Lifestyle Intervention for Heart Failure

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00633633
First received: March 5, 2008
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Heart Failure
Other: Usual Care
Behavioral: Exercise Training
Behavioral: Dietary Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Take Heart: Exercise & Diet Intervention for Heart Failure in Cancer Survivors

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Recruitment/Attendance/Drop-Out Rates [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 85
Study Start Date: February 2008
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1
Usual Care
Other: Usual Care
Monthly visits with the cardiology team and a booklet about coping with heart failure.
Experimental: Group 2
Exercise Training + Dietary Counseling
Other: Usual Care
Monthly visits with the cardiology team and a booklet about coping with heart failure.
Behavioral: Exercise Training
Exercise training 3 times a week.
Behavioral: Dietary Counseling
Food log, booklet, and a cookbook to help decrease the salt content in your diet.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. diagnosis of NYHA I, II or III heart failure (as identified by any of the following physical findings of heart failure (jugular venous distension, crackles, edema, S3); pulmonary edema on chest x-ray; BNP > 100 pg/ml; or at least two of the following symptoms: paroxysmal nocturnal dyspnea, shortness of breath, swelling, fatigue;
  2. previous chemotherapy that contributed to the development of heart failure (i.e., heart failure develops or worsens after receiving chemotherapy, with no other obvious explanation);
  3. oriented to person, place, and time;
  4. living in the Houston area (Harris county or a contiguous county), or planning to stay in the area for at least the next 16 weeks.
  5. 18 years of age or older.
  6. diagnosis of cancer
  7. have completed treatment, or are on long-term adjuvant or maintenance chemotherapy only

Exclusion Criteria:

  1. remain in NYHA class IV heart failure despite therapy;
  2. have health problems or current treatments that would make exercise unsafe, as determined by the cardiologist;
  3. cannot provide informed consent;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633633

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78249
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Karen Basen-Engquist, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00633633     History of Changes
Other Study ID Numbers: 2007-0822, NCI-2011-02123
Study First Received: March 5, 2008
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Heart Failure
Lifestyle Intervention
Exercise
Diet

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014