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Stakeholder involvement in the design of a patient-centered comparative effectiveness trial of the "On the Move" group exercise program in community-dwelling older adults.

ABSTRACT: Group exercise programs for older adults often exclude the timing and coordination of movement. Stakeholder involvement in the research process is strongly encouraged and improves the relevance and adoption of findings. We describe stakeholder involvement in the design of a clinical trial of a group-based exercise program that incorporates timing and coordination of movement into the exercises.The study was a cluster randomized, single-blind intervention trial to compare the effects on function, disability and mobility of a standard group exercise program and the "On the Move" group exercise program in older adults residing in independent living facilities and senior apartment buildings, and attending community centers. Exercise classes were twice weekly for 12weeks delivered by study exercise leaders and facility activity staff personnel.The primary outcomes function, disability and mobility were assessed at baseline and post-intervention. Function and disability were assessed using the Late Life Function and Disability Instrument, and mobility using the Six-Minute Walk Test and gait speed.Patient and provider stakeholders had significant input into the study aims, design, sample, intervention, outcomes and operational considerations.A community-based exercise program to improve walking can be developed to address both investigator identified missing components in current exercise to improve walking and stakeholder defined needs and interest for the activity program. Involvement of stakeholders substantially improves the relevance of research questions, increases the transparency of research activities and may accelerate the adoption of research into practice.

SUBMITTER: Brach JS

PROVIDER: S-EPMC5035644 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Stakeholder involvement in the design of a patient-centered comparative effectiveness trial of the "On the Move" group exercise program in community-dwelling older adults.

Brach Jennifer S JS Perera Subashan S Gilmore Sandra S VanSwearingen Jessie M JM Brodine Deborah D Wert David D Nadkarni Neelesh K NK Ricci Edmund E

Contemporary clinical trials 20160810

<h4>Background</h4>Group exercise programs for older adults often exclude the timing and coordination of movement. Stakeholder involvement in the research process is strongly encouraged and improves the relevance and adoption of findings. We describe stakeholder involvement in the design of a clinical trial of a group-based exercise program that incorporates timing and coordination of movement into the exercises.<h4>Methods</h4>The study was a cluster randomized, single-blind intervention trial ...[more]

PMID: 27521806

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Project description:ImportanceTiming and coordination exercises may be an important addition to community-based health promotion exercise programs to improve walking in older adults.ObjectiveTo compare the effectiveness of the On the Move group exercise program, which focuses on the timing and coordination of movement, with a seated strength, endurance, and flexibility program (usual care) at improving function, disability, and walking ability of older adults.Design, setting, and participantsCluster-randomized, single-blind intervention trial. Thirty-two independent living facilities, senior apartment buildings, and senior community centers were randomized to On the Move (16 sites; 152 participants) or usual care (16 sites; 146 participants). Participants were 65 years or older, able to ambulate independently with a gait speed of at least 0.60 m/s, able to follow 2-step commands, and were medically stable.InterventionsExercise classes were 50 minutes, twice a week for 12 weeks and had 10 or fewer participants per class. On the Move consisted of warm-up, timing and coordination (stepping and walking patterns), strengthening, and stretching exercises. The usual-care program consisted of warm-up, strength, endurance, and stretching exercises.Main outcomes and measuresThe primary outcomes were self-report of function and disability (Late Life Function and Disability Instrument) and mobility (6-minute walk distance and gait speed) assessed by blinded individuals.ResultsParticipants (mean [SD] age, 80.0 [8.1] years) were mostly female (251 [84.2%]) and white (249 [83.6%]) and had a mean (SD) of 2.8 (1.4) chronic conditions. Intervention groups were similar on baseline characteristics. Postintervention, 142 (93.4%) participants in On the Move and 139 (95.2%) participants in usual care completed testing. On the Move had greater mean (SD) improvements than the usual-care group in gait speed (0.05 [0.13] vs -0.01 [0.11] m/s; adjusted difference = 0.05 [0.02] m/s; P = .002) and 6-minute walk distance (20.6 [57.1] vs 4.1 [55.6] m; adjusted difference = 16.7 [7.4] m; P = .03). Attendance was greater in the usual-care program compared with On the Move (95 [65.1%] vs 76 [50.0%] attended ≥20 classes; P = .03). There were no significant differences in any of the other primary or secondary outcomes.Conclusions and relevanceThe On the Move group exercise program was more effective at improving mobility than a usual-care exercise program, despite lower attendance. Additional research examining the impact of the intervention on long-term disability outcomes is needed before recommending routine implementation into clinical practice.Trial registrationclinicaltrials.gov Identifier: NCT01986647.

Project description:BackgroundDespite the clear benefits of physical activity in healthy ageing, engagement in regular physical activity among community-dwelling older adults remains low, with common barriers including exertional discomfort, concerns with falling, and access difficulties. The recent rise of the use of technology and the internet among older adults presents an opportunity to engage with older people online to promote increased physical activity. This study aims to determine the feasibility and acceptability of training volunteers to deliver online group exercises for older adults attending community social clubs.MethodsThis was a pre-post mixed-methods study. Older adults aged ≥ 65 years attending community social clubs who provided written consent and were not actively participating in exercise classes took part in the feasibility study. Older adults, volunteers, and staff were interviewed to determine the acceptability of the intervention. The intervention was a once weekly volunteer-led online group seated strength exercises using resistance bands. The duration of the intervention was 6 months. The primary outcome measures were the feasibility of the intervention (determined by the number of volunteers recruited, trained, and retained, participant recruitment and intervention adherence) and its acceptability to key stakeholders. Secondary outcome measures included physical activity levels (Community Health Model Activities Programme for Seniors (CHAMPS) questionnaire), modified Barthel Index, Health-related quality of life (EQ-5D-5L), frailty (PRISMA-7) and sarcopenia (SARC-F), at baseline and 6 months.ResultsNineteen volunteers were recruited, 15 (78.9%) completed training and 9 (47.3%) were retained after 1 year (mean age 68 years). Thirty older adults (mean age 77 years, 27 female) participated, attending 54% (IQR 37-67) of exercise sessions. Participants had no significant changes in secondary outcome measures, with a trend towards improvement in physical activity levels (physical activity in minutes per week at baseline was 1770 min, and 1909 min at six months, p = 0.13). Twenty volunteers, older adults, and staff were interviewed and found the intervention acceptable. The seated exercises were perceived as safe, manageable, and enjoyable.ConclusionsTrained volunteers can safely deliver online group exercise for community-dwelling older adults which was acceptable to older adults, volunteers, and club staff.Trials registrationNCT04672200.

Project description:BACKGROUND:Wellness program participation may reduce the risk of falling, emergency department-use, and hospitalization among older adults. "On the Move" (OTM), a community-based group exercise program focused on the timing and coordination of walking, improved mobility in older adults, but its impact on falls, emergency department-use, and hospitalizations remains unclear. The aim of this preliminary study was to investigate the potential long-term effects that OTM may have on downstream, tertiary outcomes. METHODS:We conducted a secondary analysis of a cluster-randomized, single-blind intervention trial, which compared two community-based, group exercise programs: OTM and a seated exercise program on strength, endurance, and flexibility (i.e. 'usual-care'). Program classes met for 50?min/session, 2 sessions/week, for 12?weeks. Older adults (?65?years), with the ability to ambulate independently at ?0.60?m/s were recruited. Self-reported incidence of falls, emergency department visitation, and hospitalization were assessed using automated monthly phone calls for the year following intervention completion. Participants with ?1 completed phone call were included in the analyses. Incidence rate ratios (IRRs) and 95% confidence intervals (CIs) were calculated (reference?=?usual-care). RESULTS:Participants (n?=?248) were similar on baseline characteristics and number of monthly phone calls completed. Participants in the seated exercise program attended an average of 2.9 more classes (p?=?.017). Of note, all results were not statistically significant (i.e. 95% CI overlapped a null value of 1.0). However, point estimates suggest OTM participation resulted in a decreased incidence rate of hospitalization compared to usual-care (IRR?=?0.88; 95% CI?=?0.59-1.32), and the estimates strengthened when controlling for between-group differences in attendance (adjusted IRR?=?0.82; 95% CI?=?0.56-1.21). Falls and emergency department visit incidence rates were initially greater for OTM participants, but decreased after controlling for attendance (adjusted IRR?=?1.08; 95% CI?=?0.72-1.62 and adjusted IRR?=?0.96; 95% CI?=?0.55-1.66, respectively). CONCLUSION:Compared to a community-based seated group exercise program, participation in OTM may result in a reduced risk of hospitalization. When OTM is adhered to, the risk for falling and hospitalizations are attenuated. However, definitive conclusions cannot be made. Nevertheless, it appears that a larger randomized trial, designed to specifically evaluate the impact of OTM on these downstream health outcomes is warranted. TRIAL REGISTRATION:Clinical trials.gov (NCT01986647; prospectively registered on November 18, 2013).

Project description:BackgroundA growing body of literature supports the efficacy of the health-social approach for the implementation of complex interventions to enhance self-care health management among community-dwelling older adults. However, there is little research on how interventions with this approach are implemented and disseminated in a real community setting.MethodsThis pilot study adopted an effectiveness-implementation hybrid design to 1) evaluate the effectiveness of a community-based Health-Social Partnership Program (HSPP) and 2) explore the reach, adoption, implementation, and maintenance of the HSPP in the community. Potential participants were recruited if they were aged 60 or above, owned a smartphone, and were cognitively competent. The participants received nurse-led case management with support from a social service team. Factors that hindered or facilitated the program delivery were examined to determine the implementation outcomes and sustained effects of the program. Data were collected at pre-intervention (T1), immediately post-intervention (T2), and 3 months post-intervention (T3).ResultsNinety-two older adults joined and completed the program. The recruitment rate was 76.7%. A significant interaction effect was found for the mean self-efficacy scores from T1 to T2 (Wald χ2 = 12.28, p ≤ .001). Barriers to widespread program implementation included manpower shortage, lack of experienced staff, and unpredictable environment, whereas facilitators, as suggested by the older adults, providers, and community staff members, included regular communication between the research and service teams, recruitment of participants through community centers with the support of the research team, and seamless partnership among the health-social partnership team members. Strong implementation fidelity was achieved with zero attrition rate.ConclusionMost conventional randomized controlled trials investigating the effects of community-based programs have tended to control the contextual factors rather than incorporate the program in a real setting. This pilot study was the first to use a hybrid model to test the effectiveness and outcomes of HSPP implementation. The results imply that the program has a high potential sustainability in the real-life context.Trial registrationThis study was registered at clinicaltrials.gov (NCT04442867; date of first registration 23/06/2020).

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Stakeholder involvement in the design of a patient-centered comparative effectiveness trial of the "On the Move" group exercise program in community-dwelling older adults.

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Stakeholder involvement in the design of a patient-centered comparative effectiveness trial of the "On the Move" group exercise program in community-dwelling older adults.

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