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

NCT07182071 | Active Not Recruiting

• 3 other identifiers: 2025-0981Protocol Version 7/9/2025EDUC/KINESIOLOGY
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Burden

Keywords

mothers; autism; down syndrome; disabilities; fitness

Outcome Measures

Primary Outcomes (7)

• 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

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

  up to 12 weeks

• Acceptability: Participant Satisfaction

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

  up to 12 weeks

• Acceptability: Challenges to Participation

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

  up to 12 weeks

• Acceptability: Facilitators to Participation

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

  up to 12 weeks

Secondary Outcomes (11)

• 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

Study Arms (2)

Physical Activity Program

EXPERIMENTAL

This group will enroll in the 10-week program immediately.

Behavioral: Physical Activity Program

Waitlist Control

ACTIVE COMPARATOR

This group will enroll and then be offered the 10-week program next year.

Behavioral: Waitlist for Physical Activity Program

Interventions

Physical Activity Program BEHAVIORAL

Three 60-minute supervised group exercise sessions per week for 10 weeks, led by a certified instructor.

Physical Activity Program

Waitlist for Physical Activity Program BEHAVIORAL

Three 60-minute supervised group exercise sessions per week for 10 weeks, led by a certified instructor.

Waitlist Control

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Caregiver Burden; Autistic Disorder; Down Syndrome

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Luis Columna, PhD

  UW Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 19, 2025
• Study Start: September 18, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)