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A power-assisted exercise intervention in people with profound intellectual and multiple disabilities living in a residential facility: a pilot randomised controlled trial [with consumer summary]
Bossink LWM, van der Putten AAJ, Waninge A, Vlaskamp C
Clinical Rehabilitation 2017 Sep;31(9):1168-1178
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To assess the feasibility of conducting a randomised controlled trial to determine the effectiveness of a twenty-week power-assisted exercise intervention in people with profound intellectual and multiple disabilities and to evaluate the potential beneficial effects of this intervention. DESIGN: Pilot randomised controlled trial. SETTING: A large-scale twenty-four-hour residential facility in the Netherlands. SUBJECTS: Thirty-seven persons with profound intellectual and multiple disabilities. INTERVENTION: Participants in the intervention group received a power-assisted exercise intervention three times a week for thirty minutes over a twenty-week period. Participants in the control group received care as usual. MAIN MEASURES: Trial feasibility by recruitment process and outcomes completion rates; intervention feasibility by programme compliance rates; potential outcomes by functional abilities, alertness, body composition, muscle tone, oxygen saturation, cardiovascular fitness and quality of life. RESULTS: Thirty-seven participants were recruited (mean age 32.1, SD 14.6) and were randomly allocated to intervention (n = 19) and control (n = 18) groups. Programme compliance rates ranged from 54.2% to 97.7% with a mean (SD) of 81.5% (13.4). Oxygen saturation significantly increased in the intervention group. Standardised effect sizes on the difference between groups in outcome varied between 0.02 and 0.62. CONCLUSIONS: The power-assisted exercise intervention and the trial design were feasible and acceptable to people with profound intellectual and multiple disabilities living in a residential facility. This pilot study suggests that the intervention improves oxygen saturation, but further implementation with the aim of improving other outcomes should be considered with caution.

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