Music-visual Guided Physical Activity Promotion for Adults With Intellectual Disabilities

NCT04938999 | Unknown

• 1 other identifier: 2019.624
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Although physical activity (PA) is cardiometabolic and psychologically beneficial to adults with intellectual disability (ID), its initiation and maintenance remain problematic. We examine the effects of a music-visual guided PA (MVgPA) intervention on the PA level, PA self-efficacy and interest as well as functional exercise capacity of adults with ID. Hypothesis: Compared with usual care, MVgPA can significantly increase the participant's PA level and improve their PA self-efficacy and interest, and functional exercise capacity. Design and participants: This cluster-randomized controlled trial will recruit 400 Chinese adults with mild to moderate ID from 20 residential care facilities. Intervention: Based on the information-motivation-strategy model, MVgPA comprises a motivational and strategical preparatory session and ongoing support to residential service providers and a 12-week group-based staff-facilitated MVgPA (two 75-min session/week) for adults with ID. Outcome measurement PA level (primary outcome) will be measured by using an activity tracker. PA self-efficacy and interest will be measured by the Baseline Interview Questionnaire and visual analogue scale respectively. Functional exercise capacity will be measured by six-minute walk test. All outcomes will be measured at baseline, 13 and 25 weeks. Data analysis: Intervention effects will be estimated using three-level mixed effects model. Expected results: MVgPA will effectively enhance the PA levels of adults with ID. After intervention implementation, we expect that at least 50% of the residential care facilities allocated to the intervention group will demonstrate their willingness to continue to implement the MVgPA program (score 4 out of 6, 6 = most willing).

Conditions

Intellectual Disability

Keywords

physical activity; residential care; information-motivation-strategy model

Outcome Measures

Primary Outcomes (1)

• PA level

  The physical activity level of participants will be assessed in terms of minutes of moderate-to-vigorous PA by using an activity tracker

  Change from baseline PA level at one-week and three-month post-intervention

Secondary Outcomes (2)

• Self-efficacy of performing physical activity (PA self-efficacy)

  Change from baseline PA self-efficacy level at one-week and three-month post-intervention

• Functional exercise capacity

  Change from baseline functional exercise capacity at one-week and three-month post-intervention

Other Outcomes (2)

• Interest in performing physical activity and satisfaction level of the participants of intervention group

  one-week post-intervention

• satisfaction of residential service providers with the intervention and their willingness to continue with the program

  one-week post-intervention

Study Arms (2)

MVgPA group

EXPERIMENTAL

The MVgPA group consists of 24 sessions conducted over 12 weeks for the study participants by the staff of residential care facilities. The structured MVgPA group session (10 - 12 participants) will be conducted twice per week. The 75-min music-paced physical activities will be presented in the PowerPoint slideshow. The instructions for an upper limb exercise will be presented in a large number pad in the slideshow, and the participants will then be asked to follow the actions and directions presented on the slide.

Behavioral: Music-visual guided physical activity (MVgPA)

Control group

OTHER

residential care facilities will conduct their usual activities during the study period. A trained RA2 will record the activities conducted by the residential care facilities during the study period.

Behavioral: Usual care

Interventions

Music-visual guided physical activity (MVgPA) BEHAVIORAL

The MVgPA adopts the information-motivation-strategy model to address the personal and environmental challenges in PA initiation and maintenance of adults with intellectual disability. To support the staff of residential care facilities in implementing 24 sessions of MVgPA in 12 weeks, the first six sessions will be led by the RA1 and co-facilitated by the staff, while the subsequent sessions will be conducted by the staff only. At week 6, another set of MVgPA will be implemented to increase the participant's interest; two sessions will be co-facilitated by RA1. At weeks 6 and 9, the RN and RA1 will hold a meeting with the staff of the residential care facilities to acknowledge the achievement of the staff and adults with ID, as well as to address any of their concerns related to the implementation of MVgPA, and to identify the facilitators and tackle barriers to the implementation of the MVgPA.

MVgPA group

Usual care BEHAVIORAL

As control group, residential care facilities will conduct their usual activities during the study period. A trained RA will record the activities conducted by the residential care facilities during the study period.

Control group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese adults who are aged 18 years to 64 years and are diagnosed with mild or moderate ID based on the information provided by the residential care facilities;
• Able to understand basic information and instructions of the intervention and to make decisions upon their participation;
• Classified as physically inactive (i.e., \<150-min moderate-intensity or 75-min vigorous-intensity PA/week);
• Currently using residential service user as stated in the Social Welfare Department of Hong Kong SAR.

You may not qualify if:

• Currently enrolled in a regular exercise program;
• Physically unable to participate in the MVgPA, such as having significant mobility problem;
• Participation to MVgPA will put them at physiological risk; or
• At risk of self-harm as determined by the staff of the residential care facilities.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Food and Health Bureau, Hong Kong: collaborator

Study Sites (1)

The Nethersole School of Nursing, Chinese University of Hong Kong

Hong Kong, Please Select, China

RECRUITING

MeSH Terms

Conditions

Intellectual Disability; Motor Activity

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Eligible participants recruited from the same facility will be allocated to either intervention or control groups accordingly. Group allocation will be concealed from outcome assessors and made according to the random group allocation sequence generated by an independent statistician and the sequence of entry into the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 13, 2021
• First Posted: June 25, 2021
• Study Start: January 5, 2022
• Primary Completion: May 31, 2023
• Study Completion: September 30, 2023
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)