Heart FailureNCT00633633
Lifestyle Intervention for Heart Failure
A study testing Exercise Training and Dietary Counseling in people with Heart Failure, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Exercise Training and Dietary Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Feb 2008to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78249
About this study
Official title: Take Heart: Exercise & Diet Intervention for Heart Failure in Cancer Survivors
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.
Read the detailed description
Baseline Study Procedures:
If you agree to take part in the pretest portion of this study, your cardiology team will look at a number of tests performed on your heart as part of your usual care, as well as your complete medical history, to find out if you are eligible to take part in this study.
If you are found to be eligible to take part in this study, you will be scheduled for a visit to the Behavioral Research and Treatment Center (BRTC) at MD Anderson.
Before your first visit to the BRTC, you will complete the following tasks at home:
-You will wear an accelerometer to measure your physical activity for 1 week. An accelerometer is a small device that you wear on your waist during the day. It records how active you are. You will bring the accelerometer with you when you come for your first visit in the BRTC.
During your first visit to the BRTC, the following tests and procedures will be performed:
- You will have an electrocardiogram (ECG), which takes about 10 minutes. An ECG is a test used to measure the electrical activity of the heart.
- You will have your blood pressure and heart rate measured.
- You will complete questionnaires about your symptoms, quality-of-life, psychological distress, and exercise. These should take about 60 minutes to complete.
- You will complete 2 reaction time tasks on the computer. In one task, you will press a button on the keyboard to indicate the color of a word on the screen. In the other task, the computer will present a statement and you will press a button on the keyboard to indicate whether you think it is true or false. The statements are all opinions. It is not a test of knowledge. The 2 reaction time tasks together should take a total of about 10 minutes.
- You will do an exercise test on the stationary bicycle. You will ride on the stationary bicycle for about 10-15 minutes while your heart rate, blood pressure, and breathing are recorded by certified exercise specialists. While you are pedaling, the difficulty level will be changed by the study staff. First, you will pedal at a low difficulty level. After a 5-minute warm up period, the difficulty level will be slowly increased for about 3-5 minutes until you reach the point you cannot continue at that difficulty level. After that point, the difficulty level will be lowered for about 5 minutes to allow you to cool down. You can stop the test at any time.
- Then, you will repeat completing the exercise questionnaires and the reaction time tasks on the computer, which should take about another 10 minutes.
Study Groups:
After the above test and procedures, you will be randomly assigned (as in the flip of a coin) to be in 1 of 2 groups. You will have an equal chance of being in either group.
If you are in Group 1, you will receive the usual care as provided by the cardiology service, and a booklet about coping with heart failure. Dietary counseling will be provided once a month to encourage you to follow to a low sodium diet, with the goal of limiting sodium to 2 grams per day. The dietary counseling will include education about the effects of sodium for patients with heart failure, sources of sodium in the diet, reading food labels, identifying low-sodium alternatives to high-sodium foods, and using other types of flavorings rather than salt and other high-sodium condiments. You will be given the booklet How to Follow a Low Sodium Diet from the Heart Failure Society of America (appendix S and a copy of the American Heart Association Low-Salt Cookbook, 3rd edition. If you are a tobacco user or have recently quit, you will be referred to the MD Anderson Tobacco Treatment program. At the end of 16 weeks, after you have completed your 4 month visit in the BRTC, you will be offered exercise training described below. If you want to participate in the exercise training, you may do so at that time.
If you are in Group 2, you will receive all the components of usual care, plus exercise training.
Exercise Training:
If you are in Group 2, you will visit the BRTC 3 times a week for exercise training. For the first 12 sessions, you will exercise on a stationary bicycle while your heart rate, ECG, and blood pressure are recorded.
After the cardiologist finds that you are able to exercise safely, you will use part of the exercise session to do exercise without having your heart rate, ECG, and blood pressure recorded. Your exercise sessions at the BRTC will be supervised by a study staff member at all times. After you have exercised safely for at least 4 weeks, you will begin at-home exercise program, which will be a series of exercises developed individually for you, in addition to the supervised exercise sessions in the BRTC. You will be given an exercise log to describe your at-home exercise, and any problems or symptoms you experience during or after the at-home exercise sessions.
The visits to the BRTC for exercise training will last about 1 hour. You will come to the BRTC for these visits 3 times a week for 16 weeks.
If you are in Group 1, you have the option of choosing the exercise training described above or a 12-week home-based exercise training program that you will start after your 4 - month visit to the BRTC. You will be scheduled for an in-person exercise session with the exercise physiologist at the BRTC at MD Anderson. During this visit, you will receive instructions on how to complete your exercise sessions safely and effectively at home. This visit will take about 1 hour to complete. You will be provided with an exercise recommendation that will help you work up to 30 minutes of exercise, at least 3 times a week.
The exercise physiologist will call you once a week for 12 weeks to check on your progress and answer any questions you may have about your exercise program. You will also have the opportunity to come back to MD Anderson up to 1 time a week if you would like help from the exercise physiologist.
You will be given a pedometer to wear. A pedometer is a small device (about the size of a deck of cards) that is worn on the belt and measures the number of steps you take each day. You will record the number of steps and minutes of exercise for each day on an exercise log sheet.
At Weeks 4 and 8 (+/- 7 days), you will have a telephone interview about any side effects you may be having and how well you are able to function in daily activities.
You will also be counseled on limiting how much sodium you consume. The dietary counseling will include education about the effects of sodium on patients with heart failure, sources of sodium in the diet, reading food labels, identifying low-sodium alternatives to high-sodium foods, and using other types of flavorings rather than salt and other high-sodium condiments.
These calls should take about 45 minutes.
Follow-Up Visits:
If you are in either Group 1 or Group 2, you will have an appointment with the MD Anderson cardiology team 4 months from the baseline assessment. At this visit you will be asked about your symptoms. Blood (about 1 teaspoon) will be drawn to measure biomarkers at baseline and at the 4 month visit. Biomarkers are chemical "markers" in the blood that may be related to your heart failure.
If you are in Group 1 or Group 2, you will have a follow-up visit in the BRTC about 16-18 weeks after your baseline visit.
Ten (10) days before this visit, you will receive a new accelerometer in the mail. You will be called and reminded to wear the accelerometer. You will wear the accelerometer for 7 days and then bring it to the last visit to the BRTC.
At your last follow up visit to the BRTC, the following tests and procedures will be performed:
- You will complete questionnaires about your symptoms, quality of life, psychological distress, and exercise.
- You will complete 2 reaction time tasks on the computer.
- After these questionnaires and reaction tests, you will have an ECG and your blood pressure and heart rate will be measured.
- You will have an echocardiogram.
- You will then do an exercise test on the stationary bicycle.
- Then you will repeat the exercise questionnaires and the reaction time tasks on the computer.
- You will also be asked to take part in an interview about what you thought of the exercise program and the tasks you performed at home. This interview should take about 15 minutes.
After your 16-week visit, information about your cardiac tests, health problems, and hospitalizations will be collected from your medical record.
Participants in the waiting list group who choose to participate in the exercise program after their 16 week assessment will complete questionnaires once a month to measure symptoms. After 4 months of exercise (3 months for home-based) they will repeat all the follow-up tests described above.
This is an investigational study.
Up to 80 participants will be take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Heart Failure
- Being tested
- Usual Care, Exercise Training, Dietary Counseling
- Keywords
- Heart Failure, Lifestyle Intervention, Exercise, Diet
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Monthly visits with the cardiology team and a booklet about coping with heart failure.
Exercise TrainingBehavioural
Exercise training 3 times a week.
Dietary CounselingBehavioural
Food log, booklet, and a cookbook to help decrease the salt content in your diet.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Usual Care Receives: Other: Usual Care |
| Group 2 | Experimental | Exercise Training + Dietary Counseling Receives: Other: Usual Care; Behavioral: Exercise Training; Behavioral: Dietary Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment/Attendance/Drop-Out Rates
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study start11 Feb 2008
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Basen-Engquist, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633633
- Sponsor's protocol ID
- 2007-0822
- Other IDs
- NCI-2011-02123
- Status last verified
- Jul 2026
- First submitted
- 5 Mar 2008
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tsai E, Mouhayar E, Lenihan D, Song J, Durand JB, Fadol A, Massey M, Harrison C, Basen-Engquist K. Feasibility and Outcomes of an Exercise Intervention for Chemotherapy-Induced Heart Failure. J Cardiopulm Rehabil Prev. 2019 May;39(3):199-203. doi: 10.1097/HCR.0000000000000388.
PubMed 31022003
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Take Heart: Exercise & Diet Intervention for Heart Failure in Cancer Survivors
- ClinicalTrials.gov ID
- NCT00633633
- Acronym / sponsor ID
- 2007-0822
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Lifestyle Intervention, Exercise, Diet
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 11 Feb 2008 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 12 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Baseline Study Procedures:
If you agree to take part in the pretest portion of this study, your cardiology team will look at a number of tests performed on your heart as part of your usual care, as well as your complete medical history, to find out if you are eligible to take part in this study.
If you are found to be eligible to take part in this study, you will be scheduled for a visit to the Behavioral Research and Treatment Center (BRTC) at MD Anderson.
Before your first visit to the BRTC, you will complete the following tasks at home:
-You will wear an accelerometer to measure your physical activity for 1 week. An accelerometer is a small device that you wear on your waist during the day. It records how active you are. You will bring the accelerometer with you when you come for your first visit in the BRTC.
During your first visit to the BRTC, the following tests and procedures will be performed:
- You will have an electrocardiogram (ECG), which takes about 10 minutes. An ECG is a test used to measure the electrical activity of the heart.
- You will have your blood pressure and heart rate measured.
- You will complete questionnaires about your symptoms, quality-of-life, psychological distress, and exercise. These should take about 60 minutes to complete.
- You will complete 2 reaction time tasks on the computer. In one task, you will press a button on the keyboard to indicate the color of a word on the screen. In the other task, the computer will present a statement and you will press a button on the keyboard to indicate whether you think it is true or false. The statements are all opinions. It is not a test of knowledge. The 2 reaction time tasks together should take a total of about 10 minutes.
- You will do an exercise test on the stationary bicycle. You will ride on the stationary bicycle for about 10-15 minutes while your heart rate, blood pressure, and breathing are recorded by certified exercise specialists. While you are pedaling, the difficulty level will be changed by the study staff. First, you will pedal at a low difficulty level. After a 5-minute warm up period, the difficulty level will be slowly increased for about 3-5 minutes until you reach the point you cannot continue at that difficulty level. After that point, the difficulty level will be lowered for about 5 minutes to allow you to cool down. You can stop the test at any time.
- Then, you will repeat completing the exercise questionnaires and the reaction time tasks on the computer, which should take about another 10 minutes.
Study Groups:
After the above test and procedures, you will be randomly assigned (as in the flip of a coin) to be in 1 of 2 groups. You will have an equal chance of being in either group.
If you are in Group 1, you will receive the usual care as provided by the cardiology service, and a booklet about coping with heart failure. Dietary counseling will be provided once a month to encourage you to follow to a low sodium diet, with the goal of limiting sodium to 2 grams per day. The dietary counseling will include education about the effects of sodium for patients with heart failure, sources of sodium in the diet, reading food labels, identifying low-sodium alternatives to high-sodium foods, and using other types of flavorings rather than salt and other high-sodium condiments. You will be given the booklet How to Follow a Low Sodium Diet from the Heart Failure Society of America (appendix S and a copy of the American Heart Association Low-Salt Cookbook, 3rd edition. If you are a tobacco user or have recently quit, you will be referred to the MD Anderson Tobacco Treatment program. At the end of 16 weeks, after you have completed your 4 month visit in the BRTC, you will be offered exercise training described below. If you want to participate in the exercise training, you may do so at that time.
If you are in Group 2, you will receive all the components of usual care, plus exercise training.
Exercise Training:
If you are in Group 2, you will visit the BRTC 3 times a week for exercise training. For the first 12 sessions, you will exercise on a stationary bicycle while your heart rate, ECG, and blood pressure are recorded.
After the cardiologist finds that you are able to exercise safely, you will use part of the exercise session to do exercise without having your heart rate, ECG, and blood pressure recorded. Your exercise sessions at the BRTC will be supervised by a study staff member at all times. After you have exercised safely for at least 4 weeks, you will begin at-home exercise program, which will be a series of exercises developed individually for you, in addition to the supervised exercise sessions in the BRTC. You will be given an exercise log to describe your at-home exercise, and any problems or symptoms you experience during or after the at-home exercise sessions.
The visits to the BRTC for exercise training will last about 1 hour. You will come to the BRTC for these visits 3 times a week for 16 weeks.
If you are in Group 1, you have the option of choosing the exercise training described above or a 12-week home-based exercise training program that you will start after your 4 - month visit to the BRTC. You will be scheduled for an in-person exercise session with the exercise physiologist at the BRTC at MD Anderson. During this visit, you will receive instructions on how to complete your exercise sessions safely and effectively at home. This visit will take about 1 hour to complete. You will be provided with an exercise recommendation that will help you work up to 30 minutes of exercise, at least 3 times a week.
The exercise physiologist will call you once a week for 12 weeks to check on your progress and answer any questions you may have about your exercise program. You will also have the opportunity to come back to MD Anderson up to 1 time a week if you would like help from the exercise physiologist.
You will be given a pedometer to wear. A pedometer is a small device (about the size of a deck of cards) that is worn on the belt and measures the number of steps you take each day. You will record the number of steps and minutes of exercise for each day on an exercise log sheet.
At Weeks 4 and 8 (+/- 7 days), you will have a telephone interview about any side effects you may be having and how well you are able to function in daily activities.
You will also be counseled on limiting how much sodium you consume. The dietary counseling will include education about the effects of sodium on patients with heart failure, sources of sodium in the diet, reading food labels, identifying low-sodium alternatives to high-sodium foods, and using other types of flavorings rather than salt and other high-sodium condiments.
These calls should take about 45 minutes.
Follow-Up Visits:
If you are in either Group 1 or Group 2, you will have an appointment with the MD Anderson cardiology team 4 months from the baseline assessment. At this visit you will be asked about your symptoms. Blood (about 1 teaspoon) will be drawn to measure biomarkers at baseline and at the 4 month visit. Biomarkers are chemical "markers" in the blood that may be related to your heart failure.
If you are in Group 1 or Group 2, you will have a follow-up visit in the BRTC about 16-18 weeks after your baseline visit.
Ten (10) days before this visit, you will receive a new accelerometer in the mail. You will be called and reminded to wear the accelerometer. You will wear the accelerometer for 7 days and then bring it to the last visit to the BRTC.
At your last follow up visit to the BRTC, the following tests and procedures will be performed:
- You will complete questionnaires about your symptoms, quality of life, psychological distress, and exercise.
- You will complete 2 reaction time tasks on the computer.
- After these questionnaires and reaction tests, you will have an ECG and your blood pressure and heart rate will be measured.
- You will have an echocardiogram.
- You will then do an exercise test on the stationary bicycle.
- Then you will repeat the exercise questionnaires and the reaction time tasks on the computer.
- You will also be asked to take part in an interview about what you thought of the exercise program and the tasks you performed at home. This interview should take about 15 minutes.
After your 16-week visit, information about your cardiac tests, health problems, and hospitalizations will be collected from your medical record.
Participants in the waiting list group who choose to participate in the exercise program after their 16 week assessment will complete questionnaires once a month to measure symptoms. After 4 months of exercise (3 months for home-based) they will repeat all the follow-up tests described above.
This is an investigational study.
Up to 80 participants will be take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Other: Usual CareUsual Care |
| Group 2 | Experimental | Other: Usual Care, Behavioral: Exercise Training, Behavioral: Dietary CounselingExercise Training + Dietary Counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareMonthly visits with the cardiology team and a booklet about coping with heart failure. | Other | Group 1, Group 2 |
| Exercise TrainingExercise training 3 times a week. | Behavioural | Group 2 |
| Dietary CounselingFood log, booklet, and a cookbook to help decrease the salt content in your diet. | Behavioural | Group 2 |
Primary outcome
Recruitment/Attendance/Drop-Out Rates
Time frame: 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Derived from this study: PubMed 31022003Tsai E, Mouhayar E, Lenihan D, Song J, Durand JB, Fadol A, Massey M, Harrison C, Basen-Engquist K. Feasibility and Outcomes of an Exercise Intervention for Chemotherapy-Induced Heart Failure. J Cardiopulm Rehabil Prev. 2019 May;39(3):199-203. doi: 10.1097/HCR.0000000000000388.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Basen-Engquist, PhD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training and Dietary Counseling in people with Heart Failure, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment/Attendance/Drop-Out Rates (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00633633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.