Lifestyle Intervention for Heart Failure
This study is currently recruiting participants.
Verified February 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00633633
First received: March 5, 2008
Last updated: February 11, 2013
Last verified: February 2013
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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 2015 (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:
- 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;
- 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);
- oriented to person, place, and time;
- 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.
- 18 years of age or older.
- diagnosis of cancer
- have completed treatment, or are on long-term adjuvant or maintenance chemotherapy only
Exclusion Criteria:
- remain in NYHA class IV heart failure despite therapy;
- have health problems or current treatments that would make exercise unsafe, as determined by the cardiologist;
- cannot provide informed consent;
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633633
Contacts
| Contact: Karen Basen-Engquist, PhD | 713-792-0919 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Karen Basen-Engquist, PhD | |
| The University of Texas Health Science Center at San Antonio | Recruiting |
| 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 |
| Study First Received: | March 5, 2008 |
| Last Updated: | February 11, 2013 |
| 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 May 22, 2013