Caregiver BurdenNCT07182071
10-Week Physical Activity Program for Mothers of Children With Developmental Disabilities
A study testing Physical Activity Program and Waitlist for Physical Activity Program in people with Caregiver Burden, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- Physical Activity Program and Waitlist for Physical Activity Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2025to 13 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of a 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.
Read the 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.
- Conditions
- Caregiver Burden
- Being tested
- Physical Activity Program, Waitlist for Physical Activity Program
- Keywords
- mothers, autism, down syndrome, disabilities, fitness
- Medical subject headings
- Caregiver Burden, Autistic Disorder, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity ProgramBehavioural
Three 60-minute supervised group exercise sessions per week for 10 weeks, led by a certified instructor.
Waitlist for Physical Activity ProgramBehavioural
Three 60-minute supervised group exercise sessions per week for 10 weeks, led by a certified instructor.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Program | Experimental | This group will enroll in the 10-week program immediately. Receives: Behavioral: Physical Activity Program |
| Waitlist Control | Active comparator | This group will enroll and then be offered the 10-week program next year. Receives: Behavioral: Waitlist for Physical Activity Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment Rate
Measured: through enrollment (up to 12 weeks)
Feasibility: Percent of Sessions Attended
Measured: up to 12 weeks
Feasibility: Number of Participants Who Complete the study
Measured: up to 12 weeks
Acceptability: Participant Experiences
Measured qualitatively via semi-structured post-intervention interviews, summarized and reported by participant count.
Measured: up to 12 weeks
Acceptability: Participant Satisfaction
Measured qualitatively via semi-structured post-intervention interviews, summarized and reported by participant count.
Measured: up to 12 weeks
Acceptability: Challenges to Participation
Measured qualitatively via semi-structured post-intervention interviews, summarized and reported by participant count.
Measured: up to 12 weeks
Acceptability: Facilitators to Participation
Measured qualitatively via semi-structured post-intervention interviews, summarized and reported by participant count.
Measured: up to 12 weeks
Secondary outcomes (11)
Efficacy: Grip Strength
The participant will squeeze a handheld dynamometer as hard as possible to measure hand and forearm strength, recorded in kilograms.
Measured: baseline, week 5, week 10
Efficacy: Number of Push-Ups Participant Completes with Proper Form
The participant will perform as many push-ups as possible with proper form to test upper-body endurance.
Measured: baseline, week 5, week 10
Efficacy: Five Times Sit to Stand Test (FTSST)
The amount of time it takes for a participant to transfer from seated to standing and back to sitting five times.
Measured: baseline, week 5, week 10
Efficacy: Percent Body Fat and Lean Mass
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.
Measured: baseline, week 5, week 10
Efficacy: Fat Mass and Fat-Free Mass in Kilograms
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.
Measured: baseline, week 5, week 10
Generalized Anxiety Disorder-7 (GAD-7)
Scored from 0-21 where higher scores indicate increased anxiety.
Measured: baseline, week 5, week 10
Perceived Stress Scale (PSS)
Scored from 0-40 where higher scores indicate increased stress.
Measured: baseline, week 5, week 10
Patient Health Questionnaire-8 (PHQ-8)
Scored from 0-24 where higher scores indicate increased symptoms of depression
Measured: baseline, week 5, week 10
Penn State Worry Questionnaire (PSWQ)
Scored from 16-80 where higher scores indicate increased worry.
Measured: baseline, week 5, week 10
SF-12 Health Survey
Perceived physical and mental health subscales each scored from 0-100 with higher scores indicating better perceived physical and mental health.
Measured: baseline, week 5, week 10
International Physical Activity Questionnaire (IPAQ)
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.
Measured: baseline, week 5, week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start18 Sep 2025
- Primary completion13 May 2026
- Study completion13 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis Columna, PhD, Principal investigator, UW Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182071
- Sponsor's protocol ID
- 2025-0981
- Other IDs
- Protocol Version 7/9/2025, EDUC/KINESIOLOGY
- Status last verified
- Jun 2026
- First submitted
- 16 Sep 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a 10-Week Physical Activity Program for Mothers of Children With Developmental Disabilities
- ClinicalTrials.gov ID
- NCT07182071
- Acronym / sponsor ID
- 2025-0981
- Conditions
- Caregiver Burden
- Keywords
- mothers, autism, down syndrome, disabilities, fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 13 May 2026 (actual)
- Study completion
- 13 May 2026 (actual)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Program | Experimental | Behavioral: Physical Activity ProgramThis group will enroll in the 10-week program immediately. |
| Waitlist Control | Active comparator | Behavioral: Waitlist for Physical Activity ProgramThis group will enroll and then be offered the 10-week program next year. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity ProgramThree 60-minute supervised group exercise sessions per week for 10 weeks, led by a certified instructor. | Behavioural | Physical Activity Program |
| Waitlist for Physical Activity ProgramThree 60-minute supervised group exercise sessions per week for 10 weeks, led by a certified instructor. | Behavioural | Waitlist Control |
Primary outcome
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.
11 secondary outcomes
Efficacy: Grip Strength
Time frame: baseline, week 5, week 10
Efficacy: Number of Push-Ups Participant Completes with Proper Form
Time frame: baseline, week 5, week 10
Efficacy: Five Times Sit to Stand Test (FTSST)
Time frame: baseline, week 5, week 10
Efficacy: Percent Body Fat and Lean Mass
Time frame: baseline, week 5, week 10
Efficacy: Fat Mass and Fat-Free Mass in Kilograms
Time frame: baseline, week 5, week 10
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: baseline, week 5, week 10
Perceived Stress Scale (PSS)
Time frame: baseline, week 5, week 10
Patient Health Questionnaire-8 (PHQ-8)
Time frame: baseline, week 5, week 10
Penn State Worry Questionnaire (PSWQ)
Time frame: baseline, week 5, week 10
SF-12 Health Survey
Time frame: baseline, week 5, week 10
International Physical Activity Questionnaire (IPAQ)
Time frame: baseline, week 5, week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Columna, PhD principal investigator
UW Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Program and Waitlist for Physical Activity Program in people with Caregiver Burden, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Recruitment Rate (time frame: through enrollment (up to 12 weeks)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.