Lifestyle Intervention for Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00633633
Recruitment Status : Active, not recruiting
First Posted : March 12, 2008
Last Update Posted : March 15, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment
Heart Failure Other: Usual Care Behavioral: Exercise Training Behavioral: Dietary Counseling

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Take Heart: Exercise & Diet Intervention for Heart Failure in Cancer Survivors
Actual Study Start Date : February 2008
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Recruitment/Attendance/Drop-Out Rates [ Time Frame: 1 Year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00633633

United States, Texas
University of Texas 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
Principal Investigator: Karen Basen-Engquist, PhD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00633633     History of Changes
Other Study ID Numbers: 2007-0822
NCI-2011-02123 ( Registry Identifier: NCI CTRP )
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases