Physical Activity With Tailored E-health Support for Individuals With Intellectual Disability

Physical Activity With Tailored E-health Support for Individuals With Intellectual Disability (PA-IDe Study): a Randomised Controlled Trial

Sponsors

Lead Sponsor: University Hospital of North Norway

Collaborator: The Royal Norwegian Ministry of Health

Source University Hospital of North Norway
Brief Summary

The main objective of this project is to enhance physical activity in youths and adults with intellectual disabilities (IDs) by developing and testing a tailored e-heath support for motivation and participation in physical activity.

Detailed Description

Individuals with intellectual disability (ID) have lower levels of physical activity and greater barriers for participation in fitness activities, compared to the general population. As increased physical activity has positive effects on cardiovascular and psychosocial health, identifying effective interventions for use in everyday settings is exceedingly important. E-health like motion sensor games (exergames) and smartphone reminders for physical activity have been explored and found to be promising in people with ID.

The purpose of this study is to examine the effectiveness of an individually tailored PA programme with motivational mobile e-health support on everyday level of PA in youths and adults with ID.

The PA-IDE trial uses a prospective randomized controlled design. In total, 60 participants with a sedentary lifestyle or low physical activity level will be included, aging from 16-60 years old. The intervention consists of a tailored e-health support intervention, using smartphones or tablets to create structure and predictability of physical activities. The intervention emphasizes the communicative abilities of individual participants and use rewards and give feedback of progress to motivate individuals to increase participation in physical activity. Participants will be allocated to groups consisting of 30 participants who receive either the e-health intervention or standard care (control). All participants will be assessed at baseline, 3-, and 6 months. Participants in the intervention group, close relatives or care staff will be invited to participate in a goal-setting meeting about physical activity in the intervention period, where the Goal Attainment Scaling (GAS) will be used. Primary outcome will be physical activity level measured as steps per day with commercial wrist-worn accelerometers. Secondary outcome measures include minutes of moderate activity, energy expenditure, social support for physical activity, self-efficacy in a PA setting, behaviour problems, and goal attainment.

The investigators expect that the new intervention will perform better than standard care in terms of improved physical activity, mastery, and social support for activities. Technology offers new opportunities to influence healthy behaviours. The trial results will determine the effectiveness and sustainability of a tailored e-health support intervention to increase physical activity among youths and adults with ID.

Overall Status Not yet recruiting
Start Date October 1, 2020
Completion Date June 20, 2023
Primary Completion Date December 1, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Steps per day Baseline, 3 months and 6 months
Secondary Outcome
Measure Time Frame
Physical activity Baseline, 3 months and 6 months
Blood pressure Baseline, 3 months and 6 months
Waist Circumference Baseline, 3 months and 6 months
Body Mass Index (BMI) Baseline, 3 months and 6 months
Physical functioning Baseline, 3 months and 6 months
Self-efficacy and social support Baseline, 3 months and 6 months
Challenging behaviour Baseline, 3 months and 6 months
Satisfaction with life Baseline, 3 months and 6 months
Social network Baseline, 3 months and 6 months
Goalsetting Baseline, 3 months and 6 months
Enrollment 60
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Physical activity with tailored e-health support

Description: The planned e-health intervention will contain several elements: A motivating smartphone app registers indoor- and outdoor activity as well as activity from the use of an ergometer-bike. For recording of outdoor activity commercial wrist-born accelerometers will be used. The app-solution will be motivating and result in a reward after a predefined level of activity.

Arm Group Label: Intervention

Other Name: Activity planner

Eligibility

Criteria:

Inclusion Criteria:

- Intellectual disability

- Age 15-60 years

- Low physical activity

- Sedentary lifestyle

Exclusion Criteria:

- Medical contradictions for participation

- High levels of physical activity

Gender: All

Minimum Age: 16 Years

Maximum Age: 60 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Audny Anke, Professor Principal Investigator University Hospital of North Norway
Overall Contact

Last Name: Audny Anke, Professor

Phone: +4795936333

Email: [email protected]

Verification Date

August 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Intervention

Type: Other

Description: Tailored e-heath support for physical activity with a focus on communication and rewards, using commercial accelerometers for measurements

Label: Control group

Type: No Intervention

Description: Standard care

Acronym PA-IDe
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Two-armed randomised controlled study

Primary Purpose: Other

Masking: Single (Participant)

Source: ClinicalTrials.gov