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

NCT ID: NCT04079439

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-01-01

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.

Conditions

Intellectual Disability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intervention

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

Group Type: OTHER

Physical activity with tailored e-health support

Intervention Type: BEHAVIORAL

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.

Control group

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical activity with tailored e-health support

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Royal Norwegian Ministry of Health

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Audny Anke, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital of North Norway

Locations

University Hospital of North Norway

Tromsø, , Norway

Countries

Norway

References

Michalsen H, Wangberg SC, Hartvigsen G, Jaccheri L, Muzny M, Henriksen A, Olsen MI, Thrane G, Jahnsen RB, Pettersen G, Arntzen C, Anke A. Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disabilities: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jun 29;9(6):e19213. doi: 10.2196/19213.

Reference Type: DERIVED

PMID: 32437328 (View on PubMed)

Other Identifiers

HNF1353-17

Identifier Type: -

Identifier Source: org_study_id