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Physical Activity, mHealth and Intellectual Disability - a Pilot Study

U

University Hospital of North Norway

Status

Completed

Conditions

Intellectual Disability

Treatments

Device: mHealth support tool

Study type

Interventional

Funder types

Other

Identifiers

NCT04929106
2016/1770

Details and patient eligibility

About

The main objective of this pilot study is to assess distant procedures, study experiences and feasibility of a planned randomized controlled trial investigating the use of a mHealth support tool on physical activity for individuals with intellectual disability.

Full description

For individuals with intellectual disability (ID) with low physical activity (PA) levels, new methods to increase participation in physical activity are needed. Motivation for participation in PA should include both individuals with ID, family members and staff, and it should work in a supportive way to strengthen mastery experiences. Technology-based interventions have not yet been explored extensively.

The study objective is to assess feasibility of procedures for a distant, COVID-19-secure intervention, study pre-treatment expectations and experiences of participants and their caregivers. In addition, the study will explore the effectiveness of an individually tailored PA program with motivational mobile health support on everyday levels of PA, goal setting and self-efficacy in a PA setting for youth and adults with intellectual disabilities.

The current protocol concerns the conducting of a mixed method pilot study to test intervention procedures of a planned complex randomised controlled trial, with steps per day as main outcome. Ten participants with intellectual disability are included. Assessment are at baseline, follow-up after 4 weeks and 12 weeks. Goal attainment scale will be used together with the introduction of an activity planner application named Active Leisure as the intervention. Feasibility and acceptance of procedures, activity measures and questionnaires are assessed.

The present trial will investigate how modern technology and e-health can be used in the promotion of PA in individuals with IDs. The study has potentially important implications for both individuals with IDs and their support networks. If successful, the project will provide a simple and accessible solution for promoting PA in individuals with IDs.

Enrollment

9 patients

Sex

All

Ages

16 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Low physical activity levels: determined with the question "How much of your leisure time have you been physically active in the last year?"
  • Diagnosis of intellectual disability (mild, moderate, severe, or profound)
  • Aged 16-60 years old
  • Ability to participate in the intervention
  • Ability to walk with or without support
  • Able to provide written informed consent or written informed consent can be obtained from a representative

Exclusion criteria

  • Medical contraindications for participation in programs with increased exercise, as advised by the primary care or ID specialist physician
  • High level of physical activity
  • Inability to provide written informed consent and written informed consent cannot be obtained from a representative

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

MHealth intervention
Experimental group
Description:
Tailored physical activity program with motivational mobile health support on everyday levels of physical activity
Treatment:
Device: mHealth support tool

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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