Trial Outcomes & Findings for MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum (NCT NCT01719562)
NCT ID: NCT01719562
Last Updated: 2023-05-19
Results Overview
The number of participants who completed the intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
6 months after treatment initiation
Results posted on
2023-05-19
Participant Flow
Participant milestones
| Measure |
ADDENDUM: Physical Activity Intervention
Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Physical Activity: Tailored aerobic exercise program onsite and at home.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
ADDENDUM: Healthy Living Instruction Group (Control Arm)
Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
8
|
|
Overall Study
COMPLETED
|
17
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
ADDENDUM: Physical Activity Intervention
Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Physical Activity: Tailored aerobic exercise program onsite and at home.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
ADDENDUM: Healthy Living Instruction Group (Control Arm)
Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
New cancer diagnosis
|
1
|
0
|
Baseline Characteristics
MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum
Baseline characteristics by cohort
| Measure |
ADDENDUM: Physical Activity Intervention
n=20 Participants
Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Physical Activity: Tailored aerobic exercise program onsite and at home.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
ADDENDUM: Healthy Living Instruction Group (Control Arm)
n=8 Participants
Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 16.8 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
53.65 years
STANDARD_DEVIATION 16.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Diagnosis: Hodgkin Lympoma, Non-Hodgkin Lymphoma, Breast Cancer
Hodgkin Lymphoma
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Diagnosis: Hodgkin Lympoma, Non-Hodgkin Lymphoma, Breast Cancer
Non-Hodgkin Lymphoma
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Diagnosis: Hodgkin Lympoma, Non-Hodgkin Lymphoma, Breast Cancer
Breast Cancer
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months after treatment initiationThe number of participants who completed the intervention.
Outcome measures
| Measure |
ADDENDUM: Physical Activity Intervention
n=20 Participants
Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Physical Activity: Tailored aerobic exercise program onsite and at home.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
ADDENDUM: Healthy Living Instruction Group (Control Arm)
n=8 Participants
Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
|---|---|---|
|
Number of Participants Completing the Trial (Exercise Capacity Addendum)
|
17 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 6 months after treatment initiationNumber of participants who completed the 6-minute walk test at 6-months.
Outcome measures
| Measure |
ADDENDUM: Physical Activity Intervention
n=20 Participants
Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Physical Activity: Tailored aerobic exercise program onsite and at home.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
ADDENDUM: Healthy Living Instruction Group (Control Arm)
n=8 Participants
Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
|---|---|---|
|
Number of Participants Able to Complete Assessments (Exercise Capacity Addendum)
|
14 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 months after treatmentPeak exercise cardiac output refers to the amount of blood that the heart pumps out per minute. It is an important measure of how effectively the heart is working to deliver oxygen and nutrients to the body's tissues. Peak exercise cardiac output was measured in a cardiac magnetic resonance imaging (MRI) exam.
Outcome measures
| Measure |
ADDENDUM: Physical Activity Intervention
n=8 Participants
Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Physical Activity: Tailored aerobic exercise program onsite and at home.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
ADDENDUM: Healthy Living Instruction Group (Control Arm)
n=6 Participants
Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
|---|---|---|
|
Peak Exercise Cardiac Output (Exercise Capacity Addendum)
|
16900 mL/min
Standard Deviation 3350
|
15700 mL/min
Standard Deviation 4100
|
SECONDARY outcome
Timeframe: 6 months after treatment initiationPopulation: Hospital restrictions due to COVID-19 prevented the data collection of A-V O2 on all participants who completed the study.
Arteriovenous Oxygen Difference (A-V O2) is the difference in oxygen levels between arterial blood and venous blood. A-V O2 difference is important because it reflects how much oxygen is being used by the body's tissues during exercise or physical activity. A higher A-V O2 difference is generally considered better.
Outcome measures
| Measure |
ADDENDUM: Physical Activity Intervention
n=8 Participants
Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Physical Activity: Tailored aerobic exercise program onsite and at home.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
ADDENDUM: Healthy Living Instruction Group (Control Arm)
n=6 Participants
Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
|---|---|---|
|
Arteriovenous Oxygen Difference (A-V O2) (Exercise Capacity Addendum)
|
0.00182 mL/100 mL
Standard Deviation 0.000322
|
0.00150 mL/100 mL
Standard Deviation 0.000362
|
SECONDARY outcome
Timeframe: 6 months after treatment initiationPopulation: Hospital restrictions due to COVID-19 prevented the data collection of VO2 on all participants who completed the study.
Maximum rate of oxygen consumption (VO2) is an objective measure of cardiorespiratory fitness. VO2 was assessed with a cardiopulmonary exercise test (CPET). Higher VO2 represents greater cardiorespiratory fitness.
Outcome measures
| Measure |
ADDENDUM: Physical Activity Intervention
n=9 Participants
Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Physical Activity: Tailored aerobic exercise program onsite and at home.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
ADDENDUM: Healthy Living Instruction Group (Control Arm)
n=6 Participants
Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
|---|---|---|
|
Maximum Rate of Oxygen Consumption (VO2) (Exercise Capacity Addendum)
|
29.6 mL/kg/min
Standard Deviation 5.83
|
23.6 mL/kg/min
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: 6 months after treatment initiationPopulation: Hospital restrictions due to COVID-19 prevented the data collection of LVEF on all participants who completed the study.
Left ventricular ejection fraction (LVEF, %) is a measure of cardiac function. LVEF was assessed with a cardiac magnetic resonance imaging (MRI) exam. The higher the LVEF, the more efficiently the heart is at pumping blood to the rest of the body with every heart beat.
Outcome measures
| Measure |
ADDENDUM: Physical Activity Intervention
n=9 Participants
Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Physical Activity: Tailored aerobic exercise program onsite and at home.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
ADDENDUM: Healthy Living Instruction Group (Control Arm)
n=6 Participants
Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
|---|---|---|
|
Left Ventricular Function (Exercise Capacity Addendum)
|
65.3 LVEF Percentage
Standard Deviation 8.06
|
65.1 LVEF Percentage
Standard Deviation 5.76
|
SECONDARY outcome
Timeframe: 6 months after treatment initiationPopulation: Hospital restrictions due to COVID-19 prevented the data collection of the COWA test on all participants who completed the study.
The COWA test was used to assess cognitive function and verbal fluency. Participants were asked to produce as many words as they can that begin with the given letter (i.e. T or L) within a 1-min time period. The COWA test total score was measured by summing the total number of acceptable words produced for three different letters. Minimum possible score for the COWA text is 0. There is no maximum possible score. Higher scores represent greater verbal fluency.
Outcome measures
| Measure |
ADDENDUM: Physical Activity Intervention
n=14 Participants
Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Physical Activity: Tailored aerobic exercise program onsite and at home.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
ADDENDUM: Healthy Living Instruction Group (Control Arm)
n=4 Participants
Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
|---|---|---|
|
Cognitive Function- Controlled Oral Word Association (COWA) Test (Exercise Capacity Addendum)
|
46.5 Scores on a scale
Standard Deviation 9.53
|
39.3 Scores on a scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: 6 months after treatment initiationPopulation: Some participants refused or failed to complete the FACT-Lym survey at 6-months.
The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) is a 42-item scale used to assess the health-related quality of life of lymphoma survivors. The FACT-Lym questionnaire examines the four primary domains of HRQL: physical, social, emotional, and functional well-being, and patient's concerns related to lymphoma. The FACT-Lym was examined as a total score, ranging from 0 to 168 points. Higher scores reflect better health-related quality of life.
Outcome measures
| Measure |
ADDENDUM: Physical Activity Intervention
n=12 Participants
Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Physical Activity: Tailored aerobic exercise program onsite and at home.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
ADDENDUM: Healthy Living Instruction Group (Control Arm)
n=5 Participants
Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
|---|---|---|
|
Health-Related Quality of Life (Exercise Capacity Addendum)
|
87.3 Scores on a scale
Standard Deviation 10.3
|
76.6 Scores on a scale
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: 6 months after treatment initiationThe 6-minute walk test is a low cost sub-maximal exercise test that serves as an indirect measure of cardiorespiratory fitness. Participants were instructed to walk at their own pace to cover as much ground (in meters) as possible for 6 minutes.
Outcome measures
| Measure |
ADDENDUM: Physical Activity Intervention
n=14 Participants
Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Physical Activity: Tailored aerobic exercise program onsite and at home.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
ADDENDUM: Healthy Living Instruction Group (Control Arm)
n=7 Participants
Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
|---|---|---|
|
6-minute Walk Distance (Exercise Capacity Addendum)
|
543 meters
Standard Deviation 90.6
|
457 meters
Standard Deviation 77.0
|
SECONDARY outcome
Timeframe: 6 months after treatment initiationPopulation: Some participants refused or failed to complete the FACT-Fatigue survey at 6-months.
The FACT-fatigue is a 13-item scale that has been widely used to assess cancer-related fatigue. The FACT-fatigue questionnaire was scored by summing all 13 items with a reverse point system. This produces a range of 0 to 52, with a higher score indicating better functioning and less fatigue.
Outcome measures
| Measure |
ADDENDUM: Physical Activity Intervention
n=15 Participants
Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Physical Activity: Tailored aerobic exercise program onsite and at home.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
ADDENDUM: Healthy Living Instruction Group (Control Arm)
n=8 Participants
Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
|---|---|---|
|
Functional Assessment of Cancer Therapy - (FACT-Fatigue) (Exercise Capacity Addendum)
|
42.0 Scores on a scale
Standard Deviation 6.20
|
32.4 Scores on a scale
Standard Deviation 8.52
|
Adverse Events
ADDENDUM: Physical Activity Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
ADDENDUM: Healthy Living Instruction Group (Control Arm)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ADDENDUM: Physical Activity Intervention
n=20 participants at risk
Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Physical Activity: Tailored aerobic exercise program onsite and at home.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
ADDENDUM: Healthy Living Instruction Group (Control Arm)
n=8 participants at risk
Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants
|
|---|---|---|
|
Gastrointestinal disorders
Nausea due to home-based exercise session
|
5.0%
1/20 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place