10-Week Physical Activity Program for Mothers of Children With Developmental Disabilities

Not Applicable

Not yet recruiting

• Conditions: Caregiver Burden

• Registration Number: NCT07182071
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

The purpose of this study is to determine the feasibility and acceptability of a 10-week supervised Physical Activity program for mothers of children with developmental disabilities. 30 participants will be enrolled: 15 into an Intervention group and 15 into a Waitlist Control group.

Detailed Description

The specific aims of this study are:

* Aim 1: Determine the feasibility and acceptability of a 10-week supervised resistance training program for mothers of autistic children.

* Aim 2: Determine the potential health benefits of the 10-week physical activity program on psychological and physical health outcomes.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-16
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-19
• Last Update Posted: 2025-09-19
• Study Start: 2025-10-01
• Primary Completion: 2026-06
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Be a mother of a child with a diagnosed developmental disability (e.g., autism spectrum disorder, Down syndrome, intellectual disability) ages 4-11.
• Be able to engage in moderate-intensity exercise three times per week.
• Be able to walk independently for at least a quarter of a mile without assistance.
• Have reliable childcare arrangements during program sessions (please note: childcare will not be provided).
• Be available and willing to attend scheduled assessments and group sessions throughout the 10-week program.

Exclusion Criteria

• Are currently pregnant.
• Have a physical disability or medical condition that prevents safe participation in physical activity.
• Are already engaged in physical activity programs more than twice per week.
• Have diagnosed mental health conditions that may interfere with consistent attendance or the ability to provide informed consent.
• Are unable to communicate effectively in English.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility: Recruitment Rate	through enrollment (up to 12 weeks)
Feasibility: Percent of Sessions Attended	up to 12 weeks
Feasibility: Number of Participants Who Complete the study	up to 12 weeks
Acceptability: Participant Experiences	up to 12 weeks	Measured qualitatively via semi-structured post-intervention interviews, summarized and reported by participant count.
Acceptability: Participant Satisfaction	up to 12 weeks	Measured qualitatively via semi-structured post-intervention interviews, summarized and reported by participant count.
Acceptability: Challenges to Participation	up to 12 weeks	Measured qualitatively via semi-structured post-intervention interviews, summarized and reported by participant count.
Acceptability: Facilitators to Participation	up to 12 weeks	Measured qualitatively via semi-structured post-intervention interviews, summarized and reported by participant count.

Secondary Outcome Measures

Name	Time	Method
Efficacy: Grip Strength	baseline, week 5, week 10	The participant will squeeze a handheld dynamometer as hard as possible to measure hand and forearm strength, recorded in kilograms.
Efficacy: Number of Push-Ups Participant Completes with Proper Form	baseline, week 5, week 10	The participant will perform as many push-ups as possible with proper form to test upper-body endurance.
Efficacy: Five Times Sit to Stand Test (FTSST)	baseline, week 5, week 10	The amount of time it takes for a participant to transfer from seated to standing and back to sitting five times.
Efficacy: Percent Body Fat and Lean Mass	baseline, week 5, week 10	Body composition is measured via Bioelectrical Impedance Analysis (BIA). The participant will stand barefoot on a bioelectrical impedance device to estimate body fat and muscle levels.
Efficacy: Fat Mass and Fat-Free Mass in Kilograms	baseline, week 5, week 10	Body composition is measured via Bioelectrical Impedance Analysis (BIA). The participant will stand barefoot on a bioelectrical impedance device to estimate body fat and muscle levels.
Generalized Anxiety Disorder-7 (GAD-7)	baseline, week 5, week 10	Scored from 0-21 where higher scores indicate increased anxiety.
Perceived Stress Scale (PSS)	baseline, week 5, week 10	Scored from 0-40 where higher scores indicate increased stress.
Patient Health Questionnaire-8 (PHQ-8)	baseline, week 5, week 10	Scored from 0-24 where higher scores indicate increased symptoms of depression
Penn State Worry Questionnaire (PSWQ)	baseline, week 5, week 10	Scored from 16-80 where higher scores indicate increased worry.
SF-12 Health Survey	baseline, week 5, week 10	Perceived physical and mental health subscales each scored from 0-100 with higher scores indicating better perceived physical and mental health.
International Physical Activity Questionnaire (IPAQ)	baseline, week 5, week 10	The IPAQ assesses physical activity during the previous 7 days by asking participants how many days and how many minutes per day they engaged in vigorous activity, moderate activity, walking, and sitting. The responses are converted into metabolic equivalent (MET) minutes per week by multiplying the minutes of activity per week by an assigned MET value (walking = 3.3 METs, moderate activity = 4.0 METs, vigorous activity = 8.0 METs). The total physical activity score is the sum of MET-minutes/week across the activity categories. Higher scores reflect greater levels of physical activity.

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States