85 Participants Needed

Lifestyle Intervention for Heart Failure

Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.34678

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.127910

Who Is on the Research Team?

Karen M. Basen-Engquist | MD Anderson ...

Karen M. Basen-Engquist

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.
My heart failure was caused by previous chemotherapy.
I have heart failure with symptoms or test results confirming it.
See 3 more

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment3 Interventions
Group II: Group 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Published Research Related to This Trial

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.
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.
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.
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]

Citations

Management of heart failure. II. Counseling, education, and lifestyle modifications. [2019]
[Role of professional nurses in the management of patients with chronic heart failure in cardiac rehabilitation]. [2016]
The impact of nurse-directed patient education on quality of life and functional capacity in people with heart failure. [2007]
Predictors of physical activity behavior change among patients with heart failure enrolled in home-based cardiac rehabilitation intervention. [2023]
Therapeutic patient education in heart failure: do studies provide sufficient information about the educational programme? [2014]
Behavioral intervention, nutrition, and exercise trials in heart failure. [2011]
Cardiac rehabilitation: a comprehensive program for the management of heart failure. [2019]
Safety and effects of physical training in chronic heart failure. Results of the Chronic Heart Failure and Graded Exercise study (CHANGE) [2007]
Lifestyle Modifications for Preventing and Treating Heart Failure. [2019]
[Sodium restriction in heart failure: where are the data?] [2020]
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