Lifestyle Intervention for Heart Failure

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: NYHA IV heart failure, unsafe exercise, others

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

Compensation: Varies

Number of Visits: 6

Duration: 16 weeks

85 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this behavioral research study is to learn if education and training about exercise can help to change the lifestyle of cancer survivors with symptoms of heart failure.

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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Lifestyle Intervention for Heart Failure?

Research shows that cardiac rehabilitation, which includes exercise and lifestyle changes, is effective for people with chronic heart failure. Education and counseling about lifestyle changes, such as diet and exercise, can improve the quality of life and functional capacity for heart failure patients. ^{1 2 3 4 5}

Is lifestyle intervention for heart failure safe?

Exercise training, as part of lifestyle interventions like cardiac rehabilitation, is generally considered safe for heart failure patients and can improve their quality of life and functional capacity. ^{2 4 6 7 8}

How does the lifestyle intervention treatment for heart failure differ from other treatments?

This lifestyle intervention treatment for heart failure is unique because it focuses on non-drug approaches like diet, exercise, and behavioral changes, which can improve symptoms and quality of life without the side effects of medications. Unlike standard treatments that often rely on drugs or devices, this approach emphasizes overall health improvements through lifestyle changes, such as sodium restriction and cardiac rehabilitation, which have shown promising results in managing heart failure. ^{1 6 7 9 10}

Research Team

Karen M. Basen-Engquist

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for cancer survivors over 18 living in or near Houston, who've finished treatment or are on maintenance chemo. They must have heart failure (NYHA I-III) possibly due to previous chemotherapy and be mentally oriented. Those with severe heart failure (NYHA IV), conditions making exercise unsafe, or unable to consent are excluded.

Inclusion Criteria

I am aware of who I am, where I am, and the current time.

I am 18 years old or older.

My heart failure was caused by previous chemotherapy.

Exclusion Criteria

My heart failure is severe, even with treatment.

Cannot provide informed consent

My doctor says it's unsafe for me to exercise due to my health or current treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo baseline assessments including ECG, questionnaires, and exercise tests

1 week

1 visit (in-person)

Treatment

Participants receive either usual care with dietary counseling or exercise training with dietary counseling

16 weeks

3 visits per week (in-person) for exercise group, monthly dietary counseling for usual care group

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up assessments and interviews

2-4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Dietary Counseling
• Exercise Training

Trial Overview The study examines if lifestyle changes through education about exercise and dietary counseling can improve the lives of those with heart failure post-cancer treatment. Participants will receive either regular care or added training and advice on how to incorporate healthy habits.

Participant Groups

Group I: Group 2 Experimental Treatment 3 Interventions

Exercise Training + Dietary Counseling

Group II: Group 1 Experimental Treatment 1 Intervention

Usual Care

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

A review of 19 randomized controlled trials on therapeutic patient education for heart failure revealed that while major elements of program descriptions were present, critical information such as patients' educational needs and evaluation methods were often missing.

Improving the precision of program descriptions in future studies could enhance the effectiveness of therapeutic patient education for heart failure patients, suggesting a need for standardized reporting formats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic patient education in heart failure: do studies provide sufficient information about the educational programme? Albano, MG., Jourdain, P., De Andrade, V., et al.[2014]

Exercise training is safe and beneficial for patients with heart failure, improving functional capacity, quality of life, and even survival rates, as shown in various studies.

Supervised exercise programs, particularly in cardiac rehabilitation settings, yield the best outcomes due to personalized exercise prescriptions and comprehensive management of patients' health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation: a comprehensive program for the management of heart failure. Boudreau, M., Genovese, J.[2019]

A study involving 80 patients with chronic heart failure showed that a structured endurance training program was safe, with no reported adverse events, and led to significant improvements in exercise time and quality of life.

The training increased the anaerobic threshold and decreased the ventilatory equivalent for carbon dioxide during submaximal exercise, indicating enhanced exercise capacity, although it did not significantly improve peak oxygen consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effects of physical training in chronic heart failure. Results of the Chronic Heart Failure and Graded Exercise study (CHANGE) Wielenga, RP., Huisveld, IA., Bol, E., et al.[2007]

Current evidence on sodium restriction in heart failure is limited, but the ongoing Sodium-HF study aims to provide more definitive results, highlighting the need for high-quality research in lifestyle management.

The GOURMET study showed promising results by integrating sodium restriction with a broader nutritional approach, emphasizing the importance of overall dietary quality and support in improving health outcomes for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sodium restriction in heart failure: where are the data?] Navis, GJ.[2020]

References

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

Management of heart failure. II. Counseling, education, and lifestyle modifications. [2019]

2. Italy pubmed.ncbi.nlm.nih.gov

[Role of professional nurses in the management of patients with chronic heart failure in cardiac rehabilitation]. [2016]

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

The impact of nurse-directed patient education on quality of life and functional capacity in people with heart failure. [2007]

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

Predictors of physical activity behavior change among patients with heart failure enrolled in home-based cardiac rehabilitation intervention. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Therapeutic patient education in heart failure: do studies provide sufficient information about the educational programme? [2014]

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

Behavioral intervention, nutrition, and exercise trials in heart failure. [2011]

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

Cardiac rehabilitation: a comprehensive program for the management of heart failure. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Safety and effects of physical training in chronic heart failure. Results of the Chronic Heart Failure and Graded Exercise study (CHANGE) [2007]

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

Lifestyle Modifications for Preventing and Treating Heart Failure. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

[Sodium restriction in heart failure: where are the data?] [2020]