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Completed

NCT Number: NCT07182071

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

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.

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Key information

Conditions

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

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical Activity Program

Behavioral

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

Waitlist for Physical Activity Program

Behavioral

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

Primary outcomes

  1. Feasibility: Recruitment Rate

    Time frame: through enrollment (up to 12 weeks)

  2. Feasibility: Percent of Sessions Attended

    Time frame: up to 12 weeks

  3. Feasibility: Number of Participants Who Complete the study

    Time frame: up to 12 weeks

  4. Acceptability: Participant Experiences

    Time frame: up to 12 weeks

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

  5. Acceptability: Participant Satisfaction

    Time frame: up to 12 weeks

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

  6. Acceptability: Challenges to Participation

    Time frame: up to 12 weeks

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

  7. 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

  1. Efficacy: Grip Strength

    Time frame: 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.

  2. Efficacy: Number of Push-Ups Participant Completes with Proper Form

    Time frame: baseline, week 5, week 10

    The participant will perform as many push-ups as possible with proper form to test upper-body endurance.

  3. Efficacy: Five Times Sit to Stand Test (FTSST)

    Time frame: 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.

  4. Efficacy: Percent Body Fat and Lean Mass

    Time frame: 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.

  5. Efficacy: Fat Mass and Fat-Free Mass in Kilograms

    Time frame: 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.

  6. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: baseline, week 5, week 10

    Scored from 0-21 where higher scores indicate increased anxiety.

  7. Perceived Stress Scale (PSS)

    Time frame: baseline, week 5, week 10

    Scored from 0-40 where higher scores indicate increased stress.

  8. Patient Health Questionnaire-8 (PHQ-8)

    Time frame: baseline, week 5, week 10

    Scored from 0-24 where higher scores indicate increased symptoms of depression

  9. Penn State Worry Questionnaire (PSWQ)

    Time frame: baseline, week 5, week 10

    Scored from 16-80 where higher scores indicate increased worry.

  10. SF-12 Health Survey

    Time frame: 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.

  11. International Physical Activity Questionnaire (IPAQ)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2025
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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