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Clinical Trials/NCT07182071
NCT07182071
Active, not recruiting
Not Applicable

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

University of Wisconsin, Madison1 site in 1 country19 target enrollmentStarted: September 18, 2025Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
19
Locations
1
Primary Endpoint
Feasibility: Recruitment Rate

Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
25 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Be a mother of a child with a diagnosed developmental disability (e.g., autism spectrum disorder, Down syndrome, intellectual disability) ages 4-
  • 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.

Outcomes

Primary Outcomes

Feasibility: Recruitment Rate

Time Frame: through enrollment (up to 12 weeks)

Feasibility: Percent of Sessions Attended

Time Frame: up to 12 weeks

Feasibility: Number of Participants Who Complete the study

Time Frame: up to 12 weeks

Acceptability: Participant Experiences

Time Frame: up to 12 weeks

Measured qualitatively via semi-structured post-intervention interviews, summarized and reported by participant count.

Acceptability: Participant Satisfaction

Time Frame: up to 12 weeks

Measured qualitatively via semi-structured post-intervention interviews, summarized and reported by participant count.

Acceptability: Challenges to Participation

Time Frame: up to 12 weeks

Measured qualitatively via semi-structured post-intervention interviews, summarized and reported by participant count.

Acceptability: Facilitators to Participation

Time Frame: up to 12 weeks

Measured qualitatively via semi-structured post-intervention interviews, summarized and reported by participant count.

Secondary Outcomes

  • Efficacy: Grip Strength(baseline, week 5, week 10)
  • Efficacy: Number of Push-Ups Participant Completes with Proper Form(baseline, week 5, week 10)
  • Efficacy: Five Times Sit to Stand Test (FTSST)(baseline, week 5, week 10)
  • Efficacy: Percent Body Fat and Lean Mass(baseline, week 5, week 10)
  • Efficacy: Fat Mass and Fat-Free Mass in Kilograms(baseline, week 5, week 10)
  • Generalized Anxiety Disorder-7 (GAD-7)(baseline, week 5, week 10)
  • Perceived Stress Scale (PSS)(baseline, week 5, week 10)
  • Patient Health Questionnaire-8 (PHQ-8)(baseline, week 5, week 10)
  • Penn State Worry Questionnaire (PSWQ)(baseline, week 5, week 10)
  • SF-12 Health Survey(baseline, week 5, week 10)
  • International Physical Activity Questionnaire (IPAQ)(baseline, week 5, week 10)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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