Trial Outcomes & Findings for Exercise Program in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy (NCT NCT03280836)
NCT ID: NCT03280836
Last Updated: 2023-12-05
Results Overview
Acceptability of the study will be assessed by documenting the percent of eligible patients that provide consent and are enrolled in the study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
4 weeks
Results posted on
2023-12-05
Participant Flow
Participant milestones
| Measure |
Control
We ask that participants in the control arm do not start an exercise program.
|
Exercise
Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence.
Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.
Exercise: All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.
The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise Program in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Baseline characteristics by cohort
| Measure |
Control
n=10 Participants
We ask that participants in the control arm do not start an exercise program.
|
Exercise
n=9 Participants
Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence.
Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.
Exercise: All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.
The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 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
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: * Female breast cancer patients (Stage I-IIIC) * Sedentary * No previous history of anthracycline based chemotherapy * Absence of heart disease * Absence of contraindications for neoadjuvant chemotherapy * Scheduled to receive neoadjuvant chemotherapy * Primary attending oncologist approval * English speaking * Absence of contraindications for exercise stress testing
Acceptability of the study will be assessed by documenting the percent of eligible patients that provide consent and are enrolled in the study.
Outcome measures
| Measure |
All Eligible Individuals
n=74 Participants
The target population that is eligible for the study is:
* Women with a breast cancer diagnosis (Stage I-IIIC)
* Sedentary (\< 75 min/wk of moderate intensity exercise over the past month)
* No previous history of anthracycline based chemotherapy
* Absence of heart disease (clinical diagnosis of coronary artery disease, arrhythmias, congenital heart defects, dilated cardiomyopathy, or valvular heart disease)
* Absence of contraindications for neoadjuvant chemotherapy
* Scheduled to receive neoadjuvant chemotherapy
* Primary attending oncologist approval
* English speaking
* Absence of contraindications to exercise stress testing
|
Exercise
Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence.
Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.
Exercise: All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.
The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.
|
|---|---|---|
|
Acceptability: Percent of Eligible Patients That Provide Consent and Are Enrolled in the Study.
|
19 Participants
|
—
|
PRIMARY outcome
Timeframe: Introduction phase of prescribed exercise training (weeks 1-4), intermediate phase of prescribed exercise training (weeks 5-11), maintenance phase of prescribed exercise training (weeks 12-chemotherapy completion)Population: The control group was not given heart rate monitors or an exercise prescription.
Tolerability was defined for each intervention exercise training phase by the percent of weekly exercise minutes completed at the prescribed exercise intensity according to the patient's heart rate monitor.
Outcome measures
| Measure |
All Eligible Individuals
The target population that is eligible for the study is:
* Women with a breast cancer diagnosis (Stage I-IIIC)
* Sedentary (\< 75 min/wk of moderate intensity exercise over the past month)
* No previous history of anthracycline based chemotherapy
* Absence of heart disease (clinical diagnosis of coronary artery disease, arrhythmias, congenital heart defects, dilated cardiomyopathy, or valvular heart disease)
* Absence of contraindications for neoadjuvant chemotherapy
* Scheduled to receive neoadjuvant chemotherapy
* Primary attending oncologist approval
* English speaking
* Absence of contraindications to exercise stress testing
|
Exercise
n=6 Participants
Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence.
Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.
Exercise: All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.
The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.
|
|---|---|---|
|
Participant Adherence to the Exercise Intervention
Introduction phase
|
—
|
72.7 % exercise time at prescribed heart rate
Standard Error 11.5
|
|
Participant Adherence to the Exercise Intervention
Intermediate phase
|
—
|
61.0 % exercise time at prescribed heart rate
Standard Error 5.0
|
|
Participant Adherence to the Exercise Intervention
Maintenance phase
|
—
|
23.7 % exercise time at prescribed heart rate
Standard Error 7.1
|
PRIMARY outcome
Timeframe: Baseline and the window following chemotherapy completion and before surgical resection (no longer than 26 weeks from baseline)Population: Patients that withdrew, were lost to follow up, or developed treatment-induced contraindications to exercise testing, are not included in the analysis population.
Expired gas analysis (oxygen used by the body) during a submaximal treadmill exercise test determined cardiopulmonary fitness. Change between baseline and the window following chemotherapy completion and before surgical resection, was calculated as the value at the test conducted in the window following chemotherapy completion and before surgical resection minus the value at the test conducted at baseline.
Outcome measures
| Measure |
All Eligible Individuals
n=6 Participants
The target population that is eligible for the study is:
* Women with a breast cancer diagnosis (Stage I-IIIC)
* Sedentary (\< 75 min/wk of moderate intensity exercise over the past month)
* No previous history of anthracycline based chemotherapy
* Absence of heart disease (clinical diagnosis of coronary artery disease, arrhythmias, congenital heart defects, dilated cardiomyopathy, or valvular heart disease)
* Absence of contraindications for neoadjuvant chemotherapy
* Scheduled to receive neoadjuvant chemotherapy
* Primary attending oncologist approval
* English speaking
* Absence of contraindications to exercise stress testing
|
Exercise
n=7 Participants
Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence.
Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.
Exercise: All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.
The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.
|
|---|---|---|
|
Change in Cardiopulmonary Fitness Level From Baseline to the Window Following Chemotherapy Completion and Before Surgical Resection
|
-27.5 ml/kg/min
Standard Deviation 7.4
|
-1.0 ml/kg/min
Standard Deviation 13.2
|
Adverse Events
Control
Serious events: 5 serious events
Other events: 4 other events
Deaths: 0 deaths
Exercise
Serious events: 5 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=7 participants at risk；n=10 participants at risk
We ask that participants in the control arm do not start an exercise program.
|
Exercise
n=7 participants at risk；n=9 participants at risk
Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence.
Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.
Exercise: All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.
The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.
|
|---|---|---|
|
Vascular disorders
Thrombosis/embolism
|
10.0%
1/10 • Number of events 1 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
0.00%
0/9 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/10 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
11.1%
1/9 • Number of events 1 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/10 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
11.1%
1/9 • Number of events 1 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory distress
|
0.00%
0/10 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
11.1%
1/9 • Number of events 1 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
|
Infections and infestations
Febrile neutropenia
|
0.00%
0/10 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
11.1%
1/9 • Number of events 1 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
|
Cardiac disorders
Chest pain
|
10.0%
1/10 • Number of events 1 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
11.1%
1/9 • Number of events 1 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
|
Cardiac disorders
Cardiac palpitations
|
10.0%
1/10 • Number of events 1 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
0.00%
0/9 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
|
Nervous system disorders
Neuropathy
|
10.0%
1/10 • Number of events 1 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
0.00%
0/9 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
|
Hepatobiliary disorders
cholecystitis
|
10.0%
1/10 • Number of events 1 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
0.00%
0/9 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
10.0%
1/10 • Number of events 1 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
0.00%
0/9 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/10 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
11.1%
1/9 • Number of events 1 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
Other adverse events
| Measure |
Control
n=7 participants at risk；n=10 participants at risk
We ask that participants in the control arm do not start an exercise program.
|
Exercise
n=7 participants at risk；n=9 participants at risk
Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence.
Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.
Exercise: All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.
The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
14.3%
1/7 • Number of events 1 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
14.3%
1/7 • Number of events 1 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
14.3%
1/7 • Number of events 1 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
28.6%
2/7 • Number of events 2 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
|
Cardiac disorders
Chest pain
|
14.3%
1/7 • Number of events 1 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
14.3%
1/7 • Number of events 1 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
|
Nervous system disorders
Dizziness
|
28.6%
2/7 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
14.3%
1/7 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
0.00%
0/7 • Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place