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Program to improve mobility in aging (PRIMA) study: Methods and rationale of a task-oriented motor learning exercise program.

ABSTRACT: Walking difficulty is a common and costly problem in older adults. A potentially important yet unaddressed strategy to enhance walking ability through exercise intervention is to add a timing and coordination component in gait training (i.e. task specific timing and coordination exercise intervention) to the usual strength, endurance, and flexibility training. We describe the methods and rationale of a randomized single-blind, physical therapist supervised, exercise intervention trial to compare the effects of a standard strength, endurance, and flexibility program to a standard plus timing and coordination program in community-dwelling older adults walking slower than the desired gait speed of 1.2?m/s. Exercise sessions are twice weekly for 12?weeks. Participants are assessed at baseline, 12?weeks (post intervention), 24?weeks and 36?weeks. The primary outcome is gait speed, secondary outcomes represent components of the interventions (strength, endurance, flexibility, timing and coordination), and tertiary outcomes are measure of activity and participation (Late Life Function and Disability Instrument and physical activity). The findings of this trial will (1) establish if a standard-plus task specific timing and coordination program is superior to a standard strength and endurance program in improving mobility, activity and participation and (2) determine if the improvements are sustained over time. The information derived from this project will provide valuable insight into the prevention and management of walking difficulty, which is so common in older Americans.

SUBMITTER: Brach JS

PROVIDER: S-EPMC6945812 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Program to improve mobility in aging (PRIMA) study: Methods and rationale of a task-oriented motor learning exercise program.

Brach Jennifer S JS VanSwearingen Jessie M JM Gil Alexandra A Nadkarni Neelesh K NK Kriska Andrea A Cham Rakie R Perera Subashan S

Contemporary clinical trials 20191212

Walking difficulty is a common and costly problem in older adults. A potentially important yet unaddressed strategy to enhance walking ability through exercise intervention is to add a timing and coordination component in gait training (i.e. task specific timing and coordination exercise intervention) to the usual strength, endurance, and flexibility training. We describe the methods and rationale of a randomized single-blind, physical therapist supervised, exercise intervention trial to compare ...[more]

PMID: 31838258

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Project description:ImportanceClinical trials suggest that higher doses of task-oriented training are superior to current clinical practice for patients with stroke with upper extremity motor deficits.ObjectiveTo compare the efficacy of a structured, task-oriented motor training program vs usual and customary occupational therapy (UCC) during stroke rehabilitation.Design, setting, and participantsPhase 3, pragmatic, single-blind randomized trial among 361 participants with moderate motor impairment recruited from 7 US hospitals over 44 months, treated in the outpatient setting from June 2009 to March 2014.InterventionsStructured, task-oriented upper extremity training (Accelerated Skill Acquisition Program [ASAP]; n = 119); dose-equivalent occupational therapy (DEUCC; n = 120); or monitoring-only occupational therapy (UCC; n = 122). The DEUCC group was prescribed 30 one-hour sessions over 10 weeks; the UCC group was only monitored, without specification of dose.Main outcomes and measuresThe primary outcome was 12-month change in log-transformed Wolf Motor Function Test time score (WMFT, consisting of a mean of 15 timed arm movements and hand dexterity tasks). Secondary outcomes were change in WMFT time score (minimal clinically important difference [MCID] = 19 seconds) and proportion of patients improving ≥25 points on the Stroke Impact Scale (SIS) hand function score (MCID = 17.8 points).ResultsAmong the 361 randomized patients (mean age, 60.7 years; 56% men; 42% African American; mean time since stroke onset, 46 days), 304 (84%) completed the 12-month primary outcome assessment; in intention-to-treat analysis, mean group change scores (log WMFT, baseline to 12 months) were, for the ASAP group, 2.2 to 1.4 (difference, 0.82); DEUCC group, 2.0 to 1.2 (difference, 0.84); and UCC group, 2.1 to 1.4 (difference, 0.75), with no significant between-group differences (ASAP vs DEUCC: 0.14; 95% CI, -0.05 to 0.33; P = .16; ASAP vs UCC: -0.01; 95% CI, -0.22 to 0.21; P = .94; and DEUCC vs UCC: -0.14; 95% CI, -0.32 to 0.05; P = .15). Secondary outcomes for the ASAP group were WMFT change score, -8.8 seconds, and improved SIS, 73%; DEUCC group, WMFT, -8.1 seconds, and SIS, 72%; and UCC group, WMFT, -7.2 seconds, and SIS, 69%, with no significant pairwise between-group differences (ASAP vs DEUCC: WMFT, 1.8 seconds; 95% CI, -0.8 to 4.5 seconds; P = .18; improved SIS, 1%; 95% CI, -12% to 13%; P = .54; ASAP vs UCC: WMFT, -0.6 seconds, 95% CI, -3.8 to 2.6 seconds; P = .72; improved SIS, 4%; 95% CI, -9% to 16%; P = .48; and DEUCC vs UCC: WMFT, -2.1 seconds; 95% CI, -4.5 to 0.3 seconds; P = .08; improved SIS, 3%; 95% CI, -9% to 15%; P = .22). A total of 168 serious adverse events occurred in 109 participants, resulting in 8 patients withdrawing from the study.Conclusions and relevanceAmong patients with motor stroke and primarily moderate upper extremity impairment, use of a structured, task-oriented rehabilitation program did not significantly improve motor function or recovery beyond either an equivalent or a lower dose of UCC upper extremity rehabilitation. These findings do not support superiority of this program among patients with motor stroke and primarily moderate upper extremity impairment.Trial registrationclinicaltrials.gov Identifier: NCT00871715.

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:BackgroundThere is inconclusive evidence for the effectiveness of additional exercise in older hospital patients. The aims of this study were (1) to assess the feasibility of an augmented prescribed exercise program (APEP) in older acute medical patients and (2) to measure the potential effects of APEP on mobility capacity in order to assess the feasibility of a large full-scale study.MethodsWe conducted a single-center, prospective, parallel-group, single-blinded, randomized (1:1) controlled pilot and feasibility trial. Participants were recruited from acute geriatric wards of a general hospital. Key inclusion criteria were: age ≥ 65 years and walking ability. Key exclusion criteria were severe cognitive impairment and medical restriction for physical exercise interventions. Both groups received usual care, including physiotherapy. Intervention group participants were scheduled for additional exercise sessions (20-30 min, 4-5x/week). Feasibility of the trial design was assessed along pre-defined criteria for process, resources and management. Feasibility of the APEP intervention was analyzed by means of adherence, compliance and safety. Outcomes were measured at baseline and prior to hospital discharge. The primary outcome was mobility capacity (de Morton Mobility Index; DEMMI). Secondary outcomes were walking ability, physical endurance, fear of falling, frailty and length of stay.ResultsThirty-five participants were recruited (recruitment rate 20.3%). We lost 7 participants to follow-up (retention rate: 80%). Intervention group participants (n = 17) each participated in 5.3 ± 2.2 additional exercise sessions (mean duration: 23.2 ± 4.0 min; mean adherence rate 78% ± 26%). No severe adverse events occurred during study assessments or APEP sessions. There were no statistically significant differences in mean change scores in any outcome measure. A sample of 124 participants would be required to detect a difference of 4 DEMMI points (ES = 0.45) with a power of 80%.ConclusionsThis small feasibility RCT indicates that an APEP intervention may be safe and feasible in older acute medical patients. APEP may possibly induce small to moderate effects on mobility, but the clinical relevance of these effects may be limited. These results inform the planning of a larger-scale phase III study.Trial registrationGerman Clinical Trials Register ( DRKS00011262 ). Registered 27 October 2016.

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Program to improve mobility in aging (PRIMA) study: Methods and rationale of a task-oriented motor learning exercise program.

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Program to improve mobility in aging (PRIMA) study: Methods and rationale of a task-oriented motor learning exercise program.

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