Copyright ©2013 Baishideng.
World J Meta-Anal. May 26, 2013; 1(1): 27-46
Published online May 26, 2013. doi: 10.13105/wjma.v1.i1.27
Table 1 The special search strategies
#1 Search “Recreation” [MeSH Major Topic]
#2 Search “Recreation Therapy” [MeSH Major Topic]
#3 Search “Rehabilitation” [MeSH Major Topic]
#4 Search “Treatment Outcome” [MeSH Terms]
#5 Search (#1) OR #2
#6 Search (#3) OR #4
#7 Search (#5) AND #6
#8 Search (#5) AND #6 Filters: Publication date from 1990-01-01 to 2012-04-30
#9 Search (#5) AND #6 Filters: Publication date from 1990-01-01 to 2012-04-30; Humans
#10 Search (#5) AND #6 Filters: Publication date from 1990-01-01 to 2012-04-30; Humans; Randomized Controlled Trial
#1 TX recreation
#2 (MH “Recreation+”) OR (MH “Recreational Therapy”)
#3 #1 or #2
#4 TX rehabilitation
#5 (MH “Rehabilitation+”)
#6 (MH “Treatment Outcomes+”) OR (MH “Outcome Assessment”)
#7 #4 or #5 or #6
#8 #3 and #7
#9 #3 and #7
#10 #3 and #7
#11 #3 and #7
3 Web of Science
#1 Recreation
#2 Leisure
#3 #1 OR #2
#4 Rehabilitation
#5 “Quality of life”
#6 Outcome
#7 #4 OR #5 OR #6
#8 #3 AND #7
#9 Randomized OR randomised
#10 (#8 AND #9) AND Article time span = 1990-2012
4 Ichushi Web (Originally in Japanese)
#1 Recreation/TH or recreation/AL or recreational/AL or recreation/AL or Rikuryeshon/AL or recreation/AL
#2 Rehabilitation/HL or rehabilitation/AL or rehabilitation/ALAL
#3 #1 and #2
#4 (#3) and (DT = 1990:2012 PT = original papers CK = person)
#5 (#4) and (RD = randomized controlled trials, quasi-randomized controlled trials, comparative studies)
#6 (#4) and (RD = randomized controlled trials)
#1 recreation
6 All Cochrane
#1 MeSH descriptor Recreation explode all trees
#2 (recreation): ti, ab, kw
#3 MeSH descriptor Rehabilitation explode all trees
#4 MeSH descriptor Randomized Controlled Trials as Topic explode all trees
#5 (Randomized controlled trial): ti, ab, kw
#6 (#1 OR #2)
#7 (#4 OR #5)
#8 (#3 AND #6 AND #7), from 1990 to 2012
7 Campbell Collaboration
#1 Recreation
#1 Recreation
9 Clinical
#1 Recreation OR recreational
10 UMIN-CTR (Originally in Japanese)
#1 Recreation
11 Japic CTI (Originally in Japanese)
#1 Recreation
12 JMACCT CTR (Originally in Japanese)
#1 Recreation
Table 2 References to studies excluded in this review
Excusion No.Ref.TitleReason of exclusion
1Green et al[48]Physiotherapy for patients with mobility problems more than 1 year after stroke: a randomised controlled trialNot recreation activity
2Kobayashi et al[49]Effects of a fall prevention program on physiacal activities of elderly people living in a rural region: an interventional trialCommunity-dwelling healthy elderly
3Das et al[50]The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: A randomized controlled trialCross-over design
4Hurwitz et al[51]Effects of recreational physical activity and back exercises on low back pain and psychological distress: Findings from the UCLA low back pain studyObservational study
5Matsuo[52]The influence of the exercise using a video game on the physical function and brain activitiesCross-over design
6Saposnik et al[53]Effectiveness of virtual reality exercises in stroke rehabilitation: rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming systemResearch protocol
7Mitsumura et al[54]Effect on physical and mental function of a group rhythm exercise for elderly persons certified under the less severe grades of long-term care insuranceExercise training
8Fraga et al[55]Aerobic resistance, functional autonomy and quality of life of elderly women impacted by a recreation and walking programCommunity-dwelling healthy elderly
9Watanabe et al[56]Effects of congnitive rehabilitation with computer training on neurophychological function in schizophreniaNot recreation activity
10Hsu et al[57]A "Wii" bit of fun: The effects of adding Nintendo Wii Bowling to a standard exercise regimen for residents of long-term care with upper extremity dysfunctionCross-over design
11Kwok et al[58]Evaluation of the Frails' Fall Efficacy by Comparing Treatments on reducing fall and fear of fall in moderately frail older adults: study protocol for a randomised control trialResearch protocol
Table 3 Brief summary of articles based on structured abstracts and additional elements
Ref.Szturm et al[27]Gil-Gómez et al[28]Saposnik et al[29]
CitationPhys Ther 2011; 91: 1449-1462J Neuroeng Rehabil 2011; 8: 30Stroke 2010; 41: 1477-1484
TitleEffects of an interactive computer game exercise regimen on balance impairment in frail community-dwelling older adults: a randomized controlled trialEffectiveness of a Wii balance board-based system (eBaViR) for balance rehabilitation: a pilot randomized clinical trial in patients with ABIEffectiveness of virtual reality using Wii gaming technology in stroke rehabilitation: a pilot randomized clinical trial and proof of principle
Aim/objectiveTo examine the feasibility and benefits of physical therapy based on a task-oriented approach delivered via an engaging, interactive video game paradigm. The intervention focused on performing targeted dynamic tasks, which included reactive balance controls and environmental interactionTo evaluate the efficacy of the eBaViR system as a rehabilitation tool for balance recovery in patients with ABITo examine the feasibility and safety the VR Nintendo Wii gaming system (VRWii) compared with RT in facilitating motor function on the upper extremity required for activities of daily living among patients with subacute stroke receiving standard rehablitation
Setting/placeA geriatric day hospital (Winnipeg, Manitoba, Canada)Hospital NISA Valencia al Mar y Sevilla A ljarafe, SpainToronto Rehabilitation Institute
ParticipantsThirty community-dwelling and ambulatory older adults. Inclusion Criteria; age: 65-85 yr, MMSE score > 24, English-speaking with the ability to understand the nature of the study and provide informed consent, independent in ambulatory functions, with or without an assistive device (cane or walker). without a disability and medical conditions (cancer, kidney disease, fracture, uncontrolled diabetes or seizure disorder, cardiovascular-related problems, stroke, multiple sclerosis, late-stage Parkinson disease, fainting, or dizzy spells)Twenty participants. Inclusion criteria were: (1) age ≥ 16 yr and < 80 yr; (2) chronicity > 6 mo; (3) absence of cognitive impairment (MMSE > 23); (4) able to follow instructions; and (5) ability to walk 10 m indoors with or without technical orthopaedic aidsParticipants (n = 22) who are 18 to 85 yr of age (mean age 61.3 yr) having a first-time ischemic or hemorrhagic stroke
InterventionThe control group received the typical rehabilitation program such as strengthening and balance exercise at the day hospital. The experimental group received a program of dynamic balance exercises coupled with computer-based video game play, using a center-of-pressure position signal as the computer mouse. The tasks were performed while standing on a fixed floor surface, with progression to a compliant sponge pad. Each group received 16 sessions, scheduled 2/wk, with 45 minEach patient participated in a total of 20 1-h-sessions of rehabilitation and accomplished a minimum of 3 sessions and a maximum of 5 sessions per week. During control sessions, traditional rehabilitation exercises that focused on balance training were practiced either individually or in a group. The sessions of the trial group were programmed according to the three games of the system (Simon, Balloon Breaker and Air Hockey) with a system based on the eBaViR. The eBaViR using Nintendo system had a significant improvement in static and/or standing balance (BBS and Anterior Reaches Test) compared to patients who underwent traditional therapy. The patients reported having had fun during the treatment without suffering from cyber side effects, which implies additional motivation and adhesion level to the treatmentParticipants received an intensive program consisting of 8 interventional sessions of 60 min each over a 14-d period. Intervention group conducted a virtual reality Wii gaming, and the control group did a RT such as card game
Main and secondary outcomesBBS, TUG, ABCBBS, Brunel Balance Assessment, and ARTFeasibility and safety were set as the main outcome, and the efficiency was a secondary outcome in this study
RandomisationGroup assignment codes were placed in envelopes and sealed. Each individual who agreed to enter the study randomly selected an envelopeThe randomization schedule was computer generated using a basic random number generatorThe randomization schedule was computer generated using a basic random number generator
Blinding/maskingAssessors were blinded to the participant group assignments. The participant names of the GaitRite data files were codedProgram specialsits and assessors were blinded to the patients group assignmentsOnly caregivers were blinded (single blinding)
Numbers randomisedExperimental group (n = 15) and Control group (n = 15)Trial group (n = 10) and Control group (n = 10)Virtual Reality Therapy (n = 11) and Recreation Therapy (n = 11)
RecruitmentThirty community-dwelling and ambulatory older adults who were attending the Riverview Health Center Day Hospital for treatment of limitations were recruited to participate in this study“Seventy-nine hemiparetic patients who had sustained an ABI and were attending a rehabilitation program were potential candidates for participation in this study”110 potential candidates were screened to participate in EVREST (the Effectiveness of Virtual Reality Excercises in Stroke Rehabiritation), and a total of 88 patients were excluded
Numbers analysedExperimental group (n = 14) and Control group (n = 13)Trial group (n = 9) and Control group (n = 8)Virtual Reality Therapy (n = 10) and Recreation Therapy (n = 10) on the primary end point
OutcomeFinding demonstrated significant improvements in posttreatment balance performance scores for both group, and change scores were significantly greater in the experimental group compared with the control group (BBS; P = 0.001, ABC; P = 0.02). No significant treatment effect was observed in either group for the TUG or spatiotemporal gait variablesPatients using eBaViR had a significant improvement in static balance (P = 0.011 in BBS and P = 0.011 in ART) compared to patients who underwent traditional therapy. Regarding dynamic balance, the results showed significant improvement over time in all these measures, but no significant group effect or group-by-time interaction was detected for any of them, which suggest that both groups improved in the same wayFeasibility (time tolerance) and safety (intervention-related adverse event) did not show significant difference between groups. In contrast, the intervention group showed a significant improvement in mean motor function (Wolf Motor Function Test) compared to the control group (-7.4 s; 95%CI: -14.5--0.2)
HarmNo descriptionNo adverse eventsNo adverse events
ConclusionDynamic balance exercises on fixed and compliant sponge surfaces were feasibly coupled to interactive video game-based exercise. This coupling, in turn, resulted in a greater improvement in dynamic standing balance control compared with the typical exercise program. However, there was no transfer of effect to gait functionThe results suggest that eBaViR represents a safe and effective alternative to traditional treatment to improve static balance in the ABI populationVirtual reality Wii gaming technology represents a safe, feasible, and potentially effective alternative to facilitate rehabilitation therapy and promote motor recovery after stroke
Trial registrationClinical (NCT01381237)No registrationNo description
FoundGrant from the Riverview Health Centre Foundation, Winnipeg, Manitoba, Canada: The Fund provided the space at their facility and access to their day hospital program clients for assessment and treatment of the control groupMinisterio de Educación y Ciencia Spain, Projects Consolider-C (SEJ2006-14301/PSIC), “CIBER of Physiopathology of Obesity and Nutrition, an initiative of ISCIII” and the Excellence Research Program PROMETEOThis study was supported by a grant from the Ministry of Health and Long Term Care through the Ontario Stroke System, administered by Heart and Stroke Foundation of Ontario
Cost of interventionNo descriptionNo descriptionNo description
Ref.Bauer et al[30]Adamo et al[31]Hackney et al[32]
CitationJ Womens Health (Larchmt) 2010; 19: 523-531Appl Physiol Nutr Metab 2010; 35: 805-815J Rehabil Med 2009; 41: 475-481
TitleAlleviating distress during antepartum hospitalization: a randomized controlled trial of music and recreation therapyEffects of interactive video game cycling on overweight and obese adolescent healthEffects of dance on movement control in PD: a comparison of Argentine tango and American ballroom
Aim/objectiveTo examine the efficacy of a single session music or recreation therapy intervention to reduce antepartum-related distress among women with high-risk pregnancies extended antepartum hospitalizationsTo examine the efficacy of interactive video game stationary cycling (GameBike) in comparison with stationary cycling to music on adherence, energy expenditure measures, submaximal aerobic fitness, body composition, and cardiovascular disease risk markers in overweight and obese adolescents, using a randomized controlled trial designTo compare the effects of tango, waltz/foxtrot and no intervention on functional motor control in individuals with PD
Setting/placeMidwestern, suburban teaching hospital with a regional Perinatal Center with 26 private rooms on the antepartum unitThe Endocrinology clinic at the Children’s Hospital of Eastern OntarioNo description
ParticipantsParticipants (n = 80) were hospitalized with various high-risk obstetric health issues, including preterm labor, premature rupture of membranes, preeclampsia, and multiple gestations. They were all over the age of 18 (mean age 31 yr), between 24 and 38 wk of gestationThirty obese adolescents between ages of 12-17 yrFifty-eight participants with idiopathic PD participated. They were at least 40 yr of age, could stand for at least 30 min, and walk independently for ≥ 3 m with or without an assistive device
InterventionParticipants were received a 1-h music or recreation therapy intervention. Music therapists offered a range of interventions for patients, all within the current standards of care of these therapies, included music-facilitated relaxation, active music listening, song writing, music for bonding, and clinical improvisation. Recreation therapy interventions offered included adaptive leisure activities, creative arts, community resource education, and leisure awareness activitiesIn the experimental group (interactive video game cycling), participants (n = 15) were required to exercise on a GameBike interactive video gaming system that was interfaced with a Sony Play Station 2. Participants were allowed to select from variety of choices, video games to play while cycling and were permitted to switch games during the exercise session. In control group (stationary cycling to music), participants were allowed to listen to music of their choice via radio, CD, or personal music device. The instructions given participants and the general protocol for this condition was the same as for video game condition. The 10-wk program consisted of twice weekly sessions lasting a maximum of 60 min per session, respectivelyThe both dance classes were taught by the same instructor who was an experienced professional ballroom dance instructor and an American Council on Exercise certified personal trainer. Those in the dance groups attended 1-h classes twice a week, completing 20 lessons in 13 wk. Both genders spent equal time in leading and following dance roles. Healthy young volunteers, recruited from physical therapy, pre-physical therapy and pre-medical programs at Washington University and St. Louis University, served as dance partners for those with PD. Volunteers were educated about posture and gait problems associated with PD
Main and secondary outcomesAntepartum Bedrest Emotional Impact Inventory ScoresAdherence, submaximal aerobic fitness (Peak workload,Time to exhaustion,Peak heart rate), exercise behaviour, body composition, and blood parametersThe Unified Parkinson’s Disease Rating Scale Motor Subscale 3 (UPDRS), BBS, TUG, 6MWT, FOG questionnaire, and forward and backward gait (gait velocity, stride length, and single support time)
RandomisationThe groups were assigned by the research coordinator (using a Random Numbers Statistical Table and opaque envelopes containing group membership) to an intervention condition (either a music or recreation therapy) or waitlist control conditionThe randomization schedule was computer generated using a basic random number generatorRandomly selecting one of the 3 conditions from a hat
Blinding/maskingOnly participants were blinded (single blinding)No blindingThe first author was not blinded to group assignment. The evaluations were videotaped for a rater who was a specially trained physiotherapy student otherwise not involved in the study (blinded assessor). Participants were not informed of the study hypotheses
Numbers randomisedMusic therapy group (n = 19), recreation therapy group (n = 19), and control group (n = 42)Video game cycling (n = 15) and Music cycling (n = 15)Waltz/foxtrot (n = 19), Tango (n = 19), and Control (n = 20)
RecruitmentIdentified eligible patients through chart review and nursing report during 2003-2005. A total of 136 patients; once enrolled, however, 56 patients were unable to complete the studyParticipants were recruited between May 2007 and January 2009 and the final subject assessment was completed in March 2009. A total of 150 families were screened through the Endocrinology clinic at the Children's Hospital of Eastern Ontario to determine Assessed for eligibility. Thirty families me the all inclusion criteriaParticipates were recruited from the St. Louis community through advertisement at local support groups and local community events. Most were directly recruited via telephone from the Washington University Movement Disorders Center database
Numbers analysedMusic therapy group (n = 19), recreation therapy group (n = 19), and control group (n = 42)Video game cycling (n = 13) and Music cycling (n = 13)Waltz/foxtrot (n = 17), Tango (n = 14), and Control (n = 17)
OutcomeSignificant association were found between the delivery of music and recreation therapy and reduction of antepartum-related distress in women hospitalized with high-risk pregnancies. These statistically significant reductions in distress persisted over a period of up to 48-72 h (each P < 0.05)The music group had a higher rate of attendance compared with the video game group (92% vs 86%, P < 0.05). Time spent in minutes per session at vigorous intensity (80%-100% of predicted peak heart rate) (24.9 ± 20 min vs 13.7 ± 12.8 min, P < 0.05) and average distance (km) pedaled per session (12.5 ± 2.8 km vs 10.2 ± 2.2 km, P < 0.05) also favoured the music group. However, both interventions produced significant improvements in submaximal indicators of aerobic fitness as measured by a graded cycle ergometer protocolSignificant improvements were noted in tango and waltz/foxtrot on the BBS, 6MWT and backward stride length when compared with controls (P < 0.05). Control group worsened significantly with respect to disease severity, as measured by the UPDRS, and on time spent in single support during forward and backward walking
HarmNo descriptionNo adverse eventsNo description
ConclusionSingle session music and recreation therapy interventions effectively alleviate antepartum-related distress among high-risk women experiencing antepartum hospitalization and should be considered as valuable additions to any comprehensive antepartum programThe results supported the superiority of cycling to music and indicated investing in the more expensive GameBike may not be worth the costTango may target deficits associated with PD more than waltz/foxtrot, but both dances may benefit balance and locomotion
Trial registrationNo descriptionClinical (NCT00983970)No description
FoundNo descriptionThe Canadian Diabetes AssociationThe American Parkinson’s Disease Association and NIH grant K01-048437
Cost of interventionNo descriptionParticipants and their families were reimbursed CAN$10 per visit to the laboratory for parking and transportation costs, and the participants were given a CAN$20 movie theatre gift certificate following trial completionNo description
Ref.Yavuzer et al[33]Desrosiers et al[34]Siedliecki et al[4]
CitationEur J Phys Rehabil Med 2008; 44: 237-244Arch Phys Med Rehabil 2007; 88: 1095-1100J Adv Nurs 2006; 54: 553-562
Title‘’Playstation eyetoy games’’ improve upper extremity-related motor functioning in subacute stroke: a randomized controlled clinical trialEffect of a home leisure education program after stroke: a randomized controlled trialEffect of music on power, pain, depression and disability
Aim/objectiveTo evaluate the effects of “Playstation EyeToy games” on upper extremity motor recovery and upper extremity-related motor functioning of patients with subacute strokeTo evaluate the effect of a leisure education program on participation in and satisfaction with leisure activities (leisure-related outcomes), and well-being, depressive symptoms, and quality of life (primary outcomes) after strokeTo test the effect of music levels of power, pain, depression, and disability; to compare the effect of researcher-provided relaxing music choices with subject-preferred music, selected daily based on self-assessment; and to test the relationship between power and the combined dependent variable of pain, depression and disability
Setting/placeTwenty inpatients with hemiparesis after stroke in rehabilitation center from the general hospital, TurkeyHome and communityPain clinics and chiropractic office in northeast Ohio, United States
ParticipantsTwenty hemiparetic inpatients with post-stroke. Eligible criteria: (1) first hemiparesis within 12 mo; (2) Brunnstrom stage 1-4 for upper extremity; and (3) no severe cognitive disordersSixty-two people (mean age 70 yr) with strokeParticipation of 60 African American and Caucasian people aged 21-65 yr (mean age 49.7 yr) with chronic non-malignant pain CNMP
InterventionBoth the intervention group and the control group participated in a conventional stroke rehabilitation program, 5 d a week, 2-5 h/d for 4 wk. The conventional program is patient-specific and consists of neurodevelopmental facilitation techniques, physiotherapy, OT, and speech therapy. For the same 4-wk of period, the EyeToy group received an additional 30 min of VR therapy programThe experimental participants (n = 33) received the leisure education program (leisure awareness, self-awareness, and competence development) at home once a week for 8 to 12 wk. The recreational therapist was responsible for the intervention whereas the occupational therapist acted as a consultant. The control participants (n = 29) were also visited by the recreation therapist but the topics discussed were unrelated to leisure (e.g., family, cooking, politics, news, everyday life)Patterning Music (PM; subject-preferred music) group were asked to select upbeat, familiar, instrumental or vocal music to ease muscle tension and stiffness. Standard Music (SM; researcher-provided music) group were offered a choice of one 60-min relaxing instrumental music tape from a collection of five tapes (piano, jazz, orchestra, harp and synthesizer) used in several music and acute pain studies. Each group received their assigned intervention for 1-h a day for 7 consecutive days. Control group received standard care that did not include music intervention, and all participants kept a diary for 7 d
Main and secondary outcomesBrunnstrom stages and FIMMinutes of leisure activity per day, number of leisure activities, the Leisure Satisfaction Scale, the Individualized Leisure Profile, the GWBS, the Center for Epidemiological Studies Depression Scale, and the SA-SIP30Power (characterize power: awareness, choices, freedom, and a personal involvement in creating change), pain, depression, and disability
RandomisationThe randomization schedule was computer generated using a basic random number generatorThe randomization schedule was computer generated using a basic random number generatorThe random allocation sequence using the Min-8 program
Blinding/maskingAssessor was blinded to the group allocation of the subject. Patients and physical therapist were not blindedOnly assessor was blindedNo description
Numbers randomisedIntervention group (n = 10) and Control group (n = 10)Experimental participants (n = 33) and Control participants (n = 29)PM group (n = 18), SM group (n = 22), and Control group (n = 20)
Recruitment“Inpatients with hemiparesis after stroke”A total of 62 people entered the trial carried out in 2002 and 2003. Authors recruited them after a review of medical charts of people (n = 230) who were previously admitted with stroke to a rehabilitation or acute care facility up to 5 yr before the study64 patients with CNMP was recruited over a 24-mo period from 2001 to 2003 from pain clinics and a chiropractic office in northeast Ohio
Numbers analysedIntervention group (n = 10) and Control group (n = 10)Experimental participants (n = 29) and Control participants (n = 27)PM group (n = 18), SM group (n = 22), and Control group (n = 20),
OutcomeThe mean change score (95%CI) of the FIM self-care score [(5.5 (2.9-8.0) vs 1.8 (0.1-3.7), P = 0.018] showed significantly more improvement in the EyeToy group compared to the control group. No significant differences were found between the groups for the Brunnstrom stages for hand and upper extremityThere was a statistically significant difference in change scores between the groups for satisfaction with leisure with a mean difference of 11.9 points (95%CI: 4.2-19.5) and participation in active leisure with a mean difference of 14.0 min (95%CI: 3.2-24.9). There was also a statistically significant difference between groups for improvement in depressive symptoms with a mean difference of -7.2 (95%CI: -12.5--1.9). Differences between groups were not statistically significant on the SA-SIP30 (0.2; 95%CI: -1.3-1.8) and GWBS (2.2; 95%CI: -5.6-10.0)The music groups had more power and less pain (P = 0.002), depression (P = 0.001) and disability (P = 0.024) than the control group, but there were no statistically significant differences between the two music interventions. The model predicting both a direct and indirect effect for music was supported
HarmNo adverse eventsNo descriptionNo description
Conclusion“Playstation EyeToy Games” combined with a conventional stroke rehabilitation program have a potential to enhance upper extremity-related motor functioning in subacute stroke patientsThe results indicate the effectiveness of the leisure education program for improving participation in leisure activities, improving satisfaction with leisure and reducing depression in people with strokeNurses can help patients with CNMP identify and use music they enjoy as a self-administered complementary intervention to facilitate feelings of power, and to decrease perceptions of pain, depression and disability
Trial registrationNo descriptionNo descriptionNo description
FoundNo descriptionThe Canadian Institutes of Health Research (MOP-49526)The Frances Payne Bolton Alumni Association, Case Western Reserve University, Cleveland Ohio; Sigma Theta Tau, Delta Omega Research Grant; NRSA (NINR; NIH#1F31nro7565)
Cost of interventionNo descriptionNo descriptionNo description
Ref.Fitzsimmons[5]Parker et al[6]
CitationJ Gerontol Nurs 2001; 27: 14-23Clin Rehabil 2001; 15: 42-52
TitleEasy rider wheelchair biking. A nursing-recreation therapy clinical trial for the treatment of depressionA multicentre randomized controlled trial of leisure therapy and conventional occupational therapy after stroke. TOTAL Study Group. Trial of Occupational Therapy and Leisure
Aim/objectiveTo determine if participation in a therapy biking program had an effect on the degree of depression in older adults living in a long-term facility in upstate New YorkTo evaluate the effects of leisure therapy and conventional OT on the mood, leisure participation and independence in ADL of stroke patients 6 and 12 mo after hospital discharge
Setting/placeThe New York State Home for Veterans (Veterans’ Home)Five UK centres: Aintree Fazakerley Hospital, Bristol Southmead Hospital, Edinburgh Western General Hospital, Glasgow Royal Infirmary and Nottingham University Hospital
ParticipantsThirty-nine older adults (mean age 80 yr) with depression living a long-term facilityFour hundred and sixty-six stroke patients (mean age 72 yr)
InterventionEase rider Program (Therapy program) intervention. The experimental groups received the therapeutic biking program for 1 h a day, 5 d a week, for 2 wkTwo treatment groups (ADL group and Lisure group) received OT interventions at home for up to 6 mo after recruitment. The protocol specified a minimum of 10 sessions lasting not less than 30 min each. The treatment goals set in the ADL group were in term of improving independence in self-care tasks and therefore treatment involved practising these task (such as preparing a meal or walking outdoor). For the leisure group, goals were set in term of leisure activity and so interventions included practising the leisure task as well as any ADL tasks necessary achieve the leisure objective. Control group received no OT treatment within the trial
Main and secondary outcomesThe short-form Geriatric Depression ScaleFor mood, the GHQ/For leisure activity, the Nottingham Leisure Questionnaire/For independence in ADL, the Nottingham Extended ADL Scale
RandomisationNo descriptionThe Collaborative Stroke Audit and Research telephone randomization service was used to allocate patients to one of three group: leisure, ADL and control
Blinding/maskingNo descriptionOnly participants were blinded
Numbers randomisedTreatment group (n = 20) and Control group (n = 20)Leisure group (n = 153), ADL group (n = 156), and Control group (n = 157)
RecruitmentThe target population (n = 90) was residents with a diagnosis of or symptoms of depression in the New York State Home for VeteransRecruitment was conducted at five UK centres: Aintree Fazakerley Hospital, Bristol Southmead Hospital, Edinburgh Western General Hospital, Glasgow Royal Infirmary and Nottingham University Hospital. 1750 patients was registered
Numbers analysedTreatment group (n = 19) and Control group (n = 20)Leisure group (n = 113), ADL group (n = 106), and Control group (n = 112)
OutcomeThe control groups' GDS pretest means of 7.95 increased slightly at the posttest to 8.65, indicating a slight increase (+0.70) in depression. The treatment groups' pretest 7.68 decreased to 4.21 (-3.47) at the posttest, denoting a marked decrease in depression (P < 0.001)At 6 mo and compared to the control group, those allocated to leisure therapy had nonsignificantly better GHQ scores (-1.2: 95%CI: -2.9-0.5), leisure scores (+0.7: 95%CI: -1.1-2.5) and Extended ADL scores (+0.4: 95%CI: -3.8-4.5): the ADL group had nonsignificantly better GHQ scores (-0.1: 95%CI: -1.8-1.7) and Extended ADL scores (-1.4: 95%CI: -2.9-5.6) and nonsignificantly worse leisure scores (-0.3: 95%CI: -2.1-1.6). The results at 12 mo were similar
HarmNo adverse eventsNo description
ConclusionThis study contributes to the body of knowledge of nursing regarding options for the treatment of depression in older adults, and is an encouraging that psychosocial interventions may be effective in reducing depressionIn contrast to the findings of previous smaller trials, neither of the additional OT treatments showed a clear beneficial effect on mood, leisure activity or independence in ADL measured at 6 or 12 mo
Trial registrationNo descriptionNo description
FoundThe NewYork State Dementia Research Grant 2000NHS Research and Development Programme
Cost of interventionThe cost of a basic bike is approximately $3600 plus shipingNo description
Table 4 Evaluation of the quality of randomized controlled trials by using the CONSORT 2010 checklist and the checklist for reporting trials nonpharmacologic treatments
Paper Section/TopicIDCONSORT 2010; itemsChecklist for reporting trials of nonpharmacologic treatment: itemsRef.
Present description1
[27][28][29][30][31][32][33][34][4][5][6]No/sumRate (%)
Title and abstract1aIdentification as a randomised trial in the titleppppa?ppaap7/1164
1bStructured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)n/an/apppppp??p7/978
In the abstract, description of the experimental treatment, comparator, care providers, centers, and blinding statusppp????p???4/1136
Background and objectives2aScientific background and explanation of rationalepppppp?pppp10/1191
2bSpecific objectives or hypothesesppppppppppp11/11100
Trial design3aDescription of trial design (such as parallel, factorial) including allocation ratiop?ppppppppp10/1191
3bImportant changes to methods after trial commencement (such as eligibility criteria), with reasonspp?pa?paaaa4/1136
Participants4aEligibility criteria for participantsppppppppppp11/11100
4bSettings and locations where the data were collectedWhen applicable, eligibility criteria for centers and those performing the interventionsp?ppp?ppppp9/1182
Interventions5The interventions for each group with sufficient details to allow replication, including how and when they were actually administeredPrecise details of both the experimental treatment and comparatorpppp?pp?ppp9/1182
Description of the different components of the interventions and, when applicable, descriptions of the procedure for tailoring the interventions to individual participantsaappapaappp6/1155
Details of how the interventions were standardizedaaapapn/aap?p4/1040
Details of how adherence of care providers with the protocol was assessed or enhanceda?an/aapn/aa???1/911
Outcomes6aCompletely defined pre-specified primary and secondary outcome measures, including how and when they were assessedpppppppp??p9/1182
6bAny changes to trial outcomes after the trial commenced, with reasonsppan/aan/an/aaaaa2/825
Sample size7ahow sample size was determinedppa?a?paapp5/1145
7bwhen applicable, explanation of any interim analyses and stopping guidelinespaan/aan/a?aapp3/933
When applicable, details of whether and how the clustering by care providers or centers was addressedpaan/aan/a?a??p2/922
Sequence generation8aMethod used to generate the random allocation sequence?p?ppppppap8/1173
8bType of randomisation; details of any restriction (such as blocking and block size)n/an/apn/a?n/ap?aaa2/729
When applicable, how care providers were allocated to each trial groupn/an/aan/a?n/aa?p?p2/729
Allocation concealment mechanism9Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assignedaapp?pp?pap6/1155
Implementation10Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventionsaapp?pp?aap5/1145
Details of the experimental treatment and comparator as they were implementedaapp?pp?p?p6/1155
Blinding11aIf done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and howppppapppaaa7/1164
Whether or not those administering co-interventions were blinded to group assignment??a?a?a?aaa0/110
11bif relevant, description of the similarity of interventionsIf blinded, method of blinding and description of the similarity of interventionist??apapaaaaa2/1118
Statistical methods12aStatistical methods used to compare groups for primary and secondary outcomes??ppppppppp9/1182
12bMethods for additional analyses, such as subgroup analyses and adjusted analysesaan/an/aan/apapap3/838
when applicable, details of whether and how the clustering by care providers or centers was addressedaan/an/aan/aaappp3/838
Participant flow (a diagram is strongly recommended)13aFor each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcomeThe number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider or in each centeraappp?ppppp8/1173
13bFor each group, losses and exclusions after randomisation, together with reasons??ppppppppp9/1182
Recruitment14aDates defining the periods of recruitment and follow-up??p?p?ppppp7/1164
14bWhy the trial ended or was stopped??pn/apn/apppap6/967
Baseline data15A table showing baseline demographic and clinical characteristics for each groupWhen applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each groupppppappaaap7/1164
Numbers analysed16For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groupsppppppppppp11/11100
Outcomes and estimation17aFor each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)ppppapppppp10/1191
17bFor binary outcomes, presentation of both absolute and relative effect sizes is recommended??pn/aan/aaaaaa1/911
Ancillary analyses18Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratoryaan/an/aan/an/aapaa1/714
Harms19All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)apa?p?paaaa3/1127
Limitations20Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analysesppppapppppa9/1182
Generalisability21Generalisability (external validity, applicability) of the trial findingsIn addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care provides or centers in each grouppppp?p??paa6/1155
Interpretation22Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidencepppp?pp?p?p8/1173
Generalizability (external validity) of the trial findings according to the intervention, comparators, patients, and care providers and centers involved in the trial??pp????p??3/1127
Other information
Registration23Registration number and name of trial registrypa??p??????2/1118
Protocol24Where the full trial protocol can be accessed, if availablepap?a?aaaaa2/1118
Funding25Sources of funding and other support (such as supply of drugs), role of fundersp?p?apppppp8/1173
Table 5 Overall evidence and future research agenda to build evidence
Overall evidence in the presentResearch agenda
Structural description of papers based on the CONSORT 2010 and the CONSORT for nonpharmacological trials
1 Satisfactory description and methodology
There is potential for effects such as psychological status, balance or motor function, and adherence but overall evidence remains unclear(Method used to generate the random allocation sequence, blinding, care provider, estimated effect size and its precision, harm, external validity, and trial registry with protocol)
2 Description of intervention dose (if pragmatic intervention)
3 Adequate sample size to perform a meta-analysis
4 Description of adverse effects (e.g., dizziness by watching screen)
5 Description of withdrawals
6 Description of cost (e.g., gaming equipment)
7 Development of the original check item in recreation activity