Women-Only Cardiac Rehab for Cardiovascular Disease

(CARE Trial)

Overseen By Beth Perrotta

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Immunosuppressants, Injectable weight loss drugs

Disqualifiers: Frailty, Severe obesity, Uncontrolled diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a women-only cardiac rehab program is more effective and enjoyable than a mixed-gender program for women with heart conditions. Researchers will compare program adherence and health improvements among participants. Suitable candidates for this trial include women diagnosed with conditions such as stable chest pain or those who have recently undergone heart surgery and have been referred to outpatient cardiac rehab at the University of Michigan. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance cardiac rehab experiences for women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this women-only cardiac rehabilitation program is safe?

Research shows that cardiac rehabilitation (CR) is usually safe and manageable. Studies have found that CR can improve heart health by lowering blood pressure and cholesterol. It also aids in smoking cessation and enhances overall heart function.

CR is particularly beneficial for women. Women often experience improved heart health and reduced risk factors after participating in these programs. No major safety concerns have been reported specifically for women in CR. However, this pilot study focuses on a women-only CR program to explore potential benefits and differences compared to mixed-gender programs.

Overall, cardiac rehab is a promising method to improve heart health and is generally safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Women Only Cardiac Rehabilitation Program because it offers a tailored approach specifically designed for women with cardiovascular disease. Unlike the standard mixed-sex rehab programs, this program focuses on addressing the unique physiological and psychological needs of women, which can differ significantly from those of men. By creating a supportive, women-centered environment, this program aims to improve engagement and outcomes, potentially leading to more effective recovery and long-term heart health for female patients.

What evidence suggests that this trial's treatments could be effective for cardiovascular disease?

Research shows that cardiac rehabilitation (CR) can greatly improve heart health in women. Studies have found that women in these programs better control heart disease risk factors like high blood pressure and cholesterol. In this trial, participants will join either a women-only cardiac rehab program or a standard mixed-sex rehab program. Programs specifically for women have higher attendance and completion rates, which are crucial for success. These programs also enhance physical fitness, as demonstrated by improved oxygen use during exercise. Women-focused CR boosts quality of life and helps women remain committed to the program. Overall, these findings suggest that women-only CR programs could effectively improve heart health. ^{1 2 6 7 8}

Who Is on the Research Team?

Melvyn Rubenfire, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for women aged 40-80 with stable angina, recent heart attack, or who've had certain heart procedures. They must be cleared for outpatient cardiac rehab at the University of Michigan and able to participate fully in the study. Exclusions include severe kidney/liver/heart conditions, uncontrolled diabetes, extreme obesity, substance abuse issues, untreated depression or anxiety, and inability to understand English.

Inclusion Criteria

I identify as female.

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability to participate in study procedures for the duration of the study

Exclusion Criteria

Not being 'cleared' for CR based on Michigan Medicine's Division of Cardiovascular Medicine Policy and Procedures

Prior participation in CR

I have chronic kidney disease or serious liver problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a women-only cardiac rehabilitation program or a mixed-sex standard care program

12 weeks

Regular sessions as per cardiac rehabilitation protocol

Follow-up

Participants are monitored for changes in blood pressure, functional capacity, and depression symptoms

12 weeks

Follow-up assessments at program completion

Extended Follow-up

Additional monitoring of depression symptoms and exercise capacity

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Women Only Cardiac Rehabilitation Program

Trial Overview The study compares a pilot women-only cardiac rehabilitation program against the standard mixed-sex program to see if it improves attendance and clinical outcomes. Women are randomly assigned to one of these two programs to assess effectiveness and enjoyment.

How Is the Trial Designed?

Group I: Women only Cardiac Rehab program Experimental Treatment 1 Intervention

Group II: Standard of Care (mixed-sex) rehab program Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

University of Texas

Collaborator

Trials

193

Recruited

143,000+

Published Research Related to This Trial

The Women's Yoga Cardiac Rehabilitation Programme (WYCRP) was well-received by participants, with 81% attendance and positive feedback regarding its physical and emotional benefits.

The WYCRP significantly improved completion rates (95% vs. 56%) and continuation to community-based rehabilitation (72% vs. 12%) compared to the standard cardiac rehabilitation program, indicating its potential effectiveness for women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the appeal of cardiac rehabilitation for women: development and pilot testing of a women-only yoga cardiac rehabilitation programme. Murphy, BM., Zaman, S., Tucker, K., et al.[2022]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001379

Cardiac Rehabilitation in Women: A Scientific Statement ... CR results in improvement of CVD risk factors, including higher rates of tobacco cessation, lowering of blood pressure and cholesterol levels, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2995341/

The Effects of a Cardiac Rehabilitation Program Tailored ... Cardiac rehabilitation attendance and study completion rates for women in the current study were also better than previously reported. Suaya et al. found that ...

3. revportcardiol.org revportcardiol.org/en-download-pdf-S0870255125002185

Effectiveness of a cardiac rehabilitation program in women ... Effectiveness outcomes were changes in peak oxygen uptake (VO2 peak) and QoL measurements before (baseline) and after the CR program (12wk). VO2 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S037851222500461X

Effects of cardiac rehabilitation on female patients with ... This review examined the effects of women-focused cardiac rehabilitation on psychological and physical outcomes and program adherence.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9027960/

Clinical Outcomes of Cardiac Rehabilitation in Women with ... This study evaluated the clinical outcomes of cardiac rehabilitation (CR) in women with coronary artery disease (CAD) in comparison to men.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2589790X25006432

Women's Cardiovascular Health and Cardiac Rehabilitation Cardiac rehabilitation (CR) is a risk reduction program that can enhance and maintain cardiovascular health through individualized programming.

7. link.springer.com link.springer.com/article/10.1007/s11883-025-01360-5

Sex and Gender-Based Differences in Outcomes of ... CR remains underutilized among women, contributing to poor health outcomes. Novel approaches to CR show promise, but further research is ...

8. bmccardiovascdisord.biomedcentral.com bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-021-02267-0

Nature, availability, and utilization of women-focused cardiac ... A cardiac rehabilitation program to improve psychosocial outcomes of women with heart disease. J Womens Health. 2008;17:123–34. Article ...