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

Trial Summary

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 data supports the effectiveness of the treatment Women Only Cardiac Rehabilitation Program for cardiovascular disease?

Research shows that women and men benefit equally from cardiac rehabilitation programs, with improvements in health and well-being. Women-focused cardiac rehabilitation has been found to improve both physical and mental health outcomes, suggesting that a women-only program could be effective. ^{1 2 3 4 5}

Is the Women-Only Cardiac Rehab program safe for women?

The available research does not specifically address safety concerns, but it suggests that women-only cardiac rehabilitation programs are generally well-received and comparable to mixed-sex programs in terms of participation and satisfaction, indicating no major safety issues. ^{6 7 8 9 10}

What makes the Women Only Cardiac Rehabilitation Program unique compared to other treatments for cardiovascular disease?

The Women Only Cardiac Rehabilitation Program is unique because it is specifically designed to address the needs of women with heart disease, aiming to improve their participation and outcomes by offering a gender-specific approach that includes tailored exercise, psychosocial support, and education. ^{3 7 9 11 12}

What is the purpose of this trial?

The purpose of this randomized controlled study is to investigate the effect(s) of a pilot women-only cardiac rehabilitation (CR) program. The study team will be testing the effectiveness, compliance and enjoyment of this women's only cardiac rehabilitation (CR) program by comparing outcomes to those randomized to receive Michigan Medicine's current CR program (standard care), which includes people of all genders. Study hypotheses: * Women randomized to women-specific CR programming will have superior attendance and completion rates compared to women attending mixed-sex CR programming. * Women randomized to women-specific CR programming will experience greater improvement in clinical outcomes in comparison to those in mixed-sex CR programming.

Research Team

Melvyn Rubenfire, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Women in cardiac rehabilitation. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Cardiac Rehabilitation Program Adherence and Functional Capacity Among Women: A Randomized Controlled Trial. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation for women: a systematic review. [2018]

4. Ireland pubmed.ncbi.nlm.nih.gov

Outcomes and cost of women-focused cardiac rehabilitation: A systematic review and meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A cardiac rehabilitation program to improve psychosocial outcomes of women with heart disease. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation and the therapeutic environment: the importance of physical, social, and symbolic safety for programme participation among women. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Profile of women choosing mixed-sex, women-only, and home-based cardiac rehabilitation models and impact on utilization. [2022]

8. England 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Optimal Gender-Specific Strategies for the Secondary Prevention of Heart Disease in Women: A SYSTEMATIC REVIEW. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

[Findings on gender differences in the quality of care in cardiac rehabilitation: are women discriminated against?]. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Women-Focused Cardiovascular Rehabilitation: An International Council of Cardiovascular Prevention and Rehabilitation Clinical Practice Guideline. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Nature, availability, and utilization of women-focused cardiac rehabilitation: a systematic review. [2022]