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 (M 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.