Physical inactivity in persons with profound intellectual and multiple disabilities Not Applicable Physical inactivity in persons with profound intellectual and multiple disabilities
Conditions
Interventions
Participants are randomised to one of two groups using a computer minimisation programme to create two similar groups with respect to gender, age (58) and GMFCS level (IV or V).
Inter
Sponsors
University of Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Profound intellectual disability (estimated intelligence quotient (IQ) below 20–25 points or a developmental age of up to 24 months) 2. Profound or severe motor disabilities (classified as Gross Motor Function Classification System level (GMFCS) IV or V) 3. Living in a large-scale twenty-four-hour residential facility (Royal Dutch Visio de Brink) which plans to implement the power-assisted exercise intervention
Exclusion criteria
Exclusion criteria: 1. A medical condition which could not be resolved in the short term excluded participation 2. Parents or legal representative of the participants did not provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Overall trial feasibility is assessed using researcher and test assistant notes during the recruitment process 2. Intervention feasibility is assessed using programme compliance rates, measured by test assistant during every training session (three times a week over a twenty-week period) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Functional ability is measured using the Behavioural Appraisal Scales assessed by blinded test assistants at baseline and 20 weeks 2. Alertness is measured using the Alertness Observation List (observation list) assessed by blinded test assistants at baseline, 5 weeks, 10 weeks, 15 weeks and 20 weeks 3. Body composition is measured using the Body Mass Index assessed by carers at baseline, 5 weeks, 10 weeks, 15 weeks and 20 weeks 4. Muscle tone is measured using the Modified Ashworth Scale assessed by blinded test assistants at baseline, 5 weeks, 10 weeks, 15 weeks and 20 weeks 5. Oxygen saturation is weekly measured only in the intervention group using a finger pulse oximeter by test assistants at the first session of the week 6. Cardiovascular fitness is weekly measured only in the intervention group using a finger pulse oximeter by test assistants at the first session of the week 7. Quality of life is measured using the QOL-PMD (questionnaire) by carers at baseline and 20 weeks | — |
Countries
Netherlands
Outcome results
None listed