Physical Activity Program for Caregiver Burden

Overseen By Luis Columna, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Pregnancy, Physical disability, Mental health, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a 10-week exercise program to assess its manageability and benefits for mothers of children with developmental disabilities. The goal is to determine if regular physical activity can reduce the stress and burden these mothers often face. Participants will either begin the program immediately or join a waitlist to participate next year. Mothers of children aged 4-11 with conditions such as autism or Down syndrome, who can exercise moderately three times a week and have reliable childcare, may be suitable candidates. As an unphased trial, this study provides a unique opportunity for mothers to contribute to research that could enhance their well-being and support systems.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on physical activity, so it's best to check with the trial organizers for specific guidance.

What prior data suggests that this Physical Activity Program is safe for mothers of children with developmental disabilities?

Research shows that exercise programs are generally safe for caregivers. Studies have found that these programs can reduce stress and improve well-being. For instance, one study found that exercise helped lower stress and made caregivers feel healthier. Another study showed that exercise improved both physical and mental health, leading to a better quality of life.

Although these programs include some physical activity, participants usually find them manageable. No reports of serious side effects have emerged. The main goal is to enhance caregivers' health and happiness through regular, supervised exercise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to easing caregiver burden through a structured Physical Activity Program. Unlike conventional methods, which often focus on mental health support or respite care, this program directly engages caregivers in a 10-week physical activity regimen. The aim is to uncover potential physical and mental health benefits that regular exercise might offer to caregivers, providing insights into improving their overall well-being. By comparing immediate program participation with a waitlist control group, researchers hope to determine the direct impact of physical activity on reducing caregiver stress and improving quality of life.

What evidence suggests that this Physical Activity Program is effective for reducing caregiver burden?

This trial will compare a Physical Activity Program with a Waitlist Control group to assess its impact on caregiver burden. Research has shown that exercise programs can reduce stress and burden on caregivers while improving their overall well-being. Studies have found that participating in these programs can lower distress and enhance quality of life. Exercise greatly benefits caregivers' physical and mental health, with no negative side effects. Some evidence suggests that personalized exercise plans can further ease caregivers' feelings of burden. However, a recent review found limited success in reducing depression or anxiety through these programs. Overall, exercise appears to be a promising way to support caregivers. ^{1 2 3 5 6}

Who Is on the Research Team?

Luis Columna, PhD

Principal Investigator

UW Madison

Are You a Good Fit for This Trial?

This trial is for mothers of children with developmental disabilities such as autism and Down syndrome, who are experiencing caregiver burden. Participants will be split into two groups: one that starts a physical activity program immediately and another that waits to start.

Inclusion Criteria

Be able to engage in moderate-intensity exercise three times per week

I can walk at least a quarter mile by myself.

I am a mother of a child aged 4-11 with a developmental disability.

Exclusion Criteria

Are currently pregnant

Are already engaged in physical activity programs more than twice per week

I cannot communicate effectively in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 10-week supervised physical activity program

10 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Physical Activity Program

Trial Overview The study is testing a 10-week supervised Physical Activity Program to see if it's doable and helpful for these mothers. There will be 30 participants in total, with half starting the program right away and the other half waiting (Waitlist Control group).

How Is the Trial Designed?

Group I: Physical Activity Program Experimental Treatment 1 Intervention

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

Group II: Waitlist Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11836036/

Effects of physical exercise in reducing caregivers burden The results suggest that physical exercise interventions are effective in reducing caregiver burden and stress, while also enhancing overall well-being.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883941722001558

The effect of a physical activity intervention on burden and ... (2016), it was reported that physical activity interventions significantly decreased caregivers' distress and increased their well-being, quality of life, and ...

3. mdpi.com mdpi.com/2227-9032/13/10/1196

Effects of Physical Exercise on the Physical and Mental ... Physical exercise significantly improves family caregivers' physical and mental health, quality of life, and functional capacity, with no adverse effects found.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5685520/

Impact of an Individualized Physical Activity Intervention on ... This study examined secondary benefits of an individualized physical activity intervention on improving dementia family caregivers' subjective burden, ...

5. link.springer.com link.springer.com/article/10.1007/s00520-025-10120-9

How a physical exercise program performed by patients ... A recent meta-analysis further demonstrated that such interventions have limited efficacy in reducing caregiver burden, depression, or anxiety [ ...

6. journals.sagepub.com journals.sagepub.com/doi/10.1177/15333175231178384

Effects of Physical Exercise Program for Older Family ... The purpose of this study was to examine the effects of a physical activity program that utilized four self-efficacy resources in older family caregivers of ...