Effects of Physical Exercise, and Its Prescription Guided by Heart Rate Variability, on the Cardiotoxicity, Physical and Psychological Health of Breast Cancer Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- GO fit Lab- Ingesport
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- 6 months after intervention Troponin
- Last Updated
- 4 years ago
Overview
Brief Summary
Breast cancer is a chronic disease that has seen a boom in research into its treatments, improvements and effects in recent decades. These advances have also highlighted the need to use physical exercise as a countermeasure to reduce the cardiotoxicity of pharmacological treatments. Patients need a correct daily individualisation of the exercise dose necessary to produce the physiological, physical and psychological benefits. To this end, the present study will use, in a novel way in this population, heart rate variability (HRV) as a measure of training prescription. The primary objective of this randomised clinical trial is to analyse the effects of a physical exercise programme planned according to daily HRV in breast cancer patients after chemotherapy treatment. For this purpose, a 16-week intervention will be carried out with 90 breast cancer patients distributed in 3 groups (control group, conventional preprogrammed physical exercise training group and physical exercise group with HRV daily programming). Cardiorespiratory capacity, strength, flexibility, agility, balance, body composition, quality of life, fatigue, functionality, self-esteem, anxiety and depression of patients before and after the intervention will be evaluated in order to compare the effects of exercise and its programming.
Detailed Description
The intervention of 16 weeks will include exercise programmes of 48 sessions conducted three times per week for two of the three study groups. These groups will be: a group participating in a conventional training programme, based on a preplanned intensity progression; and, a group of participants involved in an exercise programme which will vary the exercise intensity regarding patients' daily Heart Rate Variability. Each session will include a warm-up, the main part of cardiovascular and strength training and a cool-down including stretching exercises. All the participants will be evaluated before and after the intervention measuring clinical, physical and psychosocial assessments. The clinical variables will be evaluated in patients' reference hospital and will involve medical history registers, cardiotoxicity variables, blood analysis and inflammatory factors measures. Physical and psychosocial variables measurement will be carried out in a sports centre and will include the assessment of: body composition, heart rate variability, cardiorespiratory capacity, upper and lower extremities' strength and flexibility, agility and balance, quality of life, fatigue, functionality, life satisfaction, self-esteem, anxiety and depression, shoulder mobility perception, kinesiophobia, physical activity level and exercise motivation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Being between 18 and 65 years
- •Being a breast cancer patient with luminal or triple-negative
- •Having completed the radiotherapy treatment, after chemotherapy, approximately one month ago.
- •Be able to perform the proposed tests safely
Exclusion Criteria
- •Being undergoing radiotherapy treatment or scheduled for surgery
- •Having metastasic cancer
- •Not having any serious psychiatric illness
Outcomes
Primary Outcomes
6 months after intervention Troponin
Time Frame: 6 months after the intervention ending
A haemogram will be carried out to analyse patients' Troponin I and T to detect their cardiotoxicity levels and the changes produced 6 months after the intervention. Troponin results will be reported in ng/L.
6 months after intervention Brain Natriuretic Peptide
Time Frame: 6 months after the intervention ending
A haemogram will be carried out to analyse patients' BNP to assess their cardiotoxicity levels and the change produced 6 after the intervention. BNP results will be reported in pg/ml.
After intervention left ventricular systolic and diastolic volume
Time Frame: Immediately after the intervention ending
An echocardiogram will be performed to measure left ventricular systolic and diastolic volume in mL and it changes after the intervention.
Baseline Brain Natriuretic Peptide
Time Frame: At baseline
A haemogram will be carried out to analyse patients' BNP to assess their cardiotoxicity levels. BNP results will be reported in pg/ml.
Baseline Troponin
Time Frame: At baseline
A haemogram will be carried out to analyse patients' Troponin I and T to detect their cardiotoxicity levels. Troponin results will be reported in ng/L.
Baseline left ventricular systolic and diastolic volume
Time Frame: At Baseline
An echocardiogram will be performed to measure left ventricular systolic and diastolic volume in mL.
Baseline left ventricular ejection fraction
Time Frame: At baseline
By an echocardiogram, patients' % of LVEF will be assessed due to its possible modification caused by cardiotoxicity.
After intervention Troponin
Time Frame: Immediately after the intervention
A haemogram will be carried out to analyse patients' Troponin I and T to detect their cardiotoxicity levels and the change produced after the intervention. Troponin results will be reported in ng/L.
After intervention Brain Natriuretic Peptide
Time Frame: Immediately after the intervention
A haemogram will be carried out to analyse patients' BNP to assess their cardiotoxicity levels and the change produced after the intervention. BNP results will be reported in pg/ml.
3 months after intervention left ventricular systolic and diastolic volume
Time Frame: 3 months after the intervention ending
An echocardiogram will be performed to measure left ventricular systolic and diastolic volume in mL and it changes 3 months after the intervention.
6 months after intervention left ventricular systolic and diastolic volume
Time Frame: 6 months after the intervention ending
An echocardiogram will be performed to measure left ventricular systolic and diastolic volume in mL and it changes 6 months after the intervention.
After intervention left ventricular ejection fraction
Time Frame: Immediately after the intervention
By an echocardiogram, patients' % of LVEF will be assessed to measure its results and its change after the intervention.
3 months after intervention Troponin
Time Frame: 3 months after the intervention ending
A haemogram will be carried out to analyse patients' Troponin I and T to detect their cardiotoxicity levels and the changes produced 3 months after the intervention. Troponin results will be reported in ng/L.
3 months after intervention Brain Natriuretic Peptide
Time Frame: 3 months after the intervention ending
A haemogram will be carried out to analyse patients' BNP to assess their cardiotoxicity levels and the change produced 3 after the intervention. BNP results will be reported in pg/ml.
3 months after intervention left ventricular ejection fraction
Time Frame: 3 months after the intervention ending
By an echocardiogram, patients' % of LVEF will be assessed to measure its results and its change 3 months after the intervention.
6 months after intervention left ventricular ejection fraction
Time Frame: 6 months after the intervention ending
By an echocardiogram, patients' % of LVEF will be assessed to measure its results and its change 6 months after the intervention.
Baseline frequency domain heart rate variability measures
Time Frame: At baseline
The assessment of heart rate variability will be performed with a Polar chest strap and electrocardiogram. Participants will remain in the supine position for 10 minutes to correctly obtain 5 minutes of a stable signal. After removal of artefacts, the frequency measures of low frequency (LF, 0.04-0.15 Hz) in ms2 and n.u, high frequency (HF, 0.15-0.4 Hz) ms2 and n.u, total power in ms2 and LF/HF ratio will be calculated.
Baseline time domain heart rate variability measures
Time Frame: At baseline
The assessment of heart rate variability will be performed with a Polar chest strap and electrocardiogram. Participants will remain in the supine position for 10 minutes to correctly obtain 5 minutes of a stable signal. After removal of artefacts, the standard deviation time domains of all RR intervals (SDNN) in ms, the mean ad all RR intervals in ms and the root mean square of the sum of squared RR interval differences in ms (RMSSD) will be recorded.
After intervention time-domain heart rate variability measures
Time Frame: Immediately after the intervention
The assessment of heart rate variability will be performed with a Polar chest strap and electrocardiogram. Participants will remain in the supine position for 10 minutes to correctly obtain 5 minutes of a stable signal. After removal of artefacts, the standard deviation time domains of all RR intervals (SDNN) in ms, the mean ad all RR intervals in ms and the root mean square of the sum of squared RR interval differences in ms (RMSSD) will be recorded after the intervention.
3 months after intervention time-domain heart rate variability measures
Time Frame: 3 months after the intervention ending
The assessment of heart rate variability will be performed with a Polar chest strap and electrocardiogram. Participants will remain in the supine position for 10 minutes to correctly obtain 5 minutes of a stable signal. After removal of artefacts, the standard deviation time domains of all RR intervals (SDNN) in ms, the mean ad all RR intervals in ms and the root mean square of the sum of squared RR interval differences in ms (RMSSD) will be recorded 3 months after the intervention.
6 months after intervention time-domain heart rate variability measures
Time Frame: 6 months after the intervention ending
The assessment of heart rate variability will be performed with a Polar chest strap and electrocardiogram. Participants will remain in the supine position for 10 minutes to correctly obtain 5 minutes of a stable signal. After removal of artefacts, the standard deviation time domains of all RR intervals (SDNN) in ms, the mean ad all RR intervals in ms and the root mean square of the sum of squared RR interval differences in ms (RMSSD) will be recorded 6 months after the intervention.
During intervention time-domain heart rate variability measures
Time Frame: During the intervention ending
Daily heart rate variability will be measured using the HRV4Training application, a validated mobile application that allows HRV values to be obtained by photoplethysmography (rMSSD, SDNN, AVNN, pNN50 and heart rate).
After intervention frequency domain heart rate variability measures
Time Frame: Immediately after the intervention
The assessment of heart rate variability will be performed with a Polar chest strap and electrocardiogram. Participants will remain in the supine position for 10 minutes to correctly obtain 5 minutes of a stable signal. After removal of artefacts, the frequency measures of low frequency (LF, 0.04-0.15 Hz) in ms2 and n.u, high frequency (HF, 0.15-0.4 Hz) ms2 and n.u, total power in ms2 and LF/HF ratio will be calculated after intervention.
During intervention frequency domain heart rate variability measures
Time Frame: During the intervention
Daily heart rate variability will be measured using the HRV4Training application, a validated mobile application that allows HRV values to be obtained by photoplethysmography (LF, HF, TP, LF/HF and recovery points)
3 months after intervention frequency domain heart rate variability measures
Time Frame: 3 months after the intervention ending
The assessment of heart rate variability will be performed with a Polar chest strap and electrocardiogram. Participants will remain in the supine position for 10 minutes to correctly obtain 5 minutes of a stable signal. After removal of artefacts, the frequency measures of low frequency (LF, 0.04-0.15 Hz) in ms2 and n.u, high frequency (HF, 0.15-0.4 Hz) ms2 and n.u, total power in ms2 and LF/HF ratio will be calculated 3 months after the intervention.
6 months after intervention frequency domain heart rate variability measures
Time Frame: 6 months after the intervention ending
The assessment of heart rate variability will be performed with a Polar chest strap and electrocardiogram. Participants will remain in the supine position for 10 minutes to correctly obtain 5 minutes of a stable signal. After removal of artefacts, the frequency measures of low frequency (LF, 0.04-0.15 Hz) in ms2 and n.u, high frequency (HF, 0.15-0.4 Hz) ms2 and n.u, total power in ms2 and LF/HF ratio will be calculated 6 months after the intervention.
Secondary Outcomes
- Baseline heart rate rhyme(At baseline)
- After intervention heart rate rhyme(Immediately after the intervention)
- 3 months after intervention heart rate rhyme(3 months after the intervention ending)
- 6 months after intervention heart rate rhyme(6 months after the intervention)
- Baseline tumor necrosis factor(At baseline)
- After intervention tumor necrosis factor(Immediately after the intervention)
- 3 months after intervention tumor necrosis factor(3 months after the intervention ending)
- 6 months after intervention tumor necrosis factor(6 months after the intervention ending)
- Baseline interleukins measurement(At baseline)
- After intervention interleukins measurement(Immediately after the intervention.)
- 3 months after intervention interleukins measurement(3 months after the intervention ending)
- 6 months after intervention interleukins measurement(6 months after the intervention ending)
- 3 months after intervention C-reactive protein measure(3 months after the intervention ending)
- Baseline C-reactive protein measure(At baseline)
- 3 months after intervention monocyte chemotactic protein measure(3 months after the intervention ending)
- 6 months after intervention monocyte chemotactic protein measure(6 months after the intervention ending)
- Baseline glucose measure(At baseline)
- After intervention glucose measure(Immediately after the intervention.)
- After intervention C-reactive protein measure(Immediately after the intervention.)
- 3 months after intervention glucose measure(3 months after the intervention ending)
- 6 months after intervention glucose measure(6 months after the intervention ending)
- 3 months after intervention cholesterol measure(3 months after the intervention ending)
- 3 months after intervention body composition weight measures(3 months after the intervention ending)
- 6 months after intervention body composition weight measures(6 months after the intervention ending)
- 3 months after intervention body composition percentages measures(3 months after the intervention ending)
- 6 months after intervention C-reactive protein measure(6 months after the intervention ending)
- Baseline monocyte chemotactic protein measure(At baseline)
- After intervention monocyte chemotactic protein measure(Immediately after the intervention.)
- Baseline cholesterol measure(At baseline)
- After intervention cholesterol measure(Immediately after the intervention.)
- 6 months after intervention cholesterol measure(6 months after the intervention ending)
- Baseline blood pressure measures(At baseline)
- After intervention blood pressure measures(Immediately after the intervention.)
- 3 months after intervention blood pressure measures(3 months after the intervention ending)
- 6 months after intervention blood pressure measures(6 months after the intervention ending)
- Baseline body composition weight measures(At baseline)
- After intervention body composition weight measures(Immediately after the intervention.)
- 6 months after intervention body composition percentages measures(6 months after the intervention ending)
- Baseline body composition percentages measures(At baseline)
- After intervention body composition percentages measures(Immediately after the intervention.)
- Baseline body water measures(At baseline)
- After intervention body water measures(Immediately after the intervention.)
- 3 months after intervention body water measures(3 months after the intervention ending)
- 3 months after intervention anthropometric measures(3 months after the intervention ending)
- Baseline measurement of lower-body strength endurance(At baseline)
- 6 months after intervention body water measures(6 months after the intervention ending)
- Baseline anthropometric measures(At baseline)
- 6 months after intervention anthropometric measures(6 months after the intervention ending)
- Baseline cardiorespiratory fitness(At baseline)
- After intervention measurement of lower-body strength endurance(Immediately after the intervention.)
- 6 months after intervention measurement of lower-body strength endurance(6 months after the intervention ending)
- Baseline maximal strength(At baseline)
- After intervention anthropometric measures(Immediately after the intervention.)
- After intervention cardiorespiratory fitness(Immediately after the intervention.)
- 3 months after intervention cardiorespiratory fitness(3 months after the intervention ending)
- 6 months after intervention cardiorespiratory fitness(6 months after the intervention ending)
- 3 months after intervention measurement of lower-body strength endurance(3 months after the intervention ending)
- 3 months after intervention maximal strength(3 months after the intervention ending)
- 3 months intervention vertical applied force(3 months after the intervention ending)
- 6 months intervention vertical applied force(6 months after the intervention ending)
- After intervention maximal strength(Immediately after the intervention.)
- 6 months after intervention maximal strength(6 months after the intervention ending)
- Baseline vertical applied force(At baseline)
- After intervention vertical applied force(Immediately after the intervention.)
- Baseline measurement of upper body strength endurance(At baseline)
- After intervention measurement of upper body strength endurance(Immediately after the intervention.)
- 3 months after intervention measurement of upper body strength endurance(3 months after the intervention ending)
- 6 months after intervention measurement of upper body strength endurance(6 months after the intervention ending)
- Baseline maximal upper body strength(At baseline)
- After intervention maximal upper body strength(Immediately after the intervention.)
- 3 months after intervention maximal upper body strength(3 months after the intervention ending)
- 6 months after intervention maximal upper body strength(6 months after the intervention ending)
- Baseline measurement of agility and dynamic balance(At baseline)
- After intervention measurement of agility and dynamic balance(Immediately after the intervention.)
- 3 months after intervention measurement of agility and dynamic balance(3 months after the intervention ending)
- 6 months after intervention measurement of agility and dynamic balance(6 months after the intervention ending)
- Baseline static monopodal balance(At baseline)
- 3 months after intervention static monopodal balance(3 months after the intervention ending)
- 6 months after intervention static monopodal balance(6 months after the intervention ending)
- 6 months after intervention measurement of upper body flexibility(6 months after the intervention ending)
- After intervention static monopodal balance(Immediately after the intervention.)
- Baseline measurement of upper body flexibility(At baseline)
- After intervention measurement of upper body flexibility(Immediately after the intervention.)
- 3 months after intervention measurement of upper body flexibility(3 months after the intervention ending)
- Baseline measurement of lower body flexibility(At baseline)
- After intervention measurement of lower body flexibility(Immediately after the intervention.)
- 3 months after intervention measurement of lower body flexibility(3 months after the intervention ending)
- 6 months after intervention measurement of lower body flexibility(6 months after the intervention ending)
- Baseline health-related quality of life measure(At baseline)
- 6 months after intervention health-related quality of life measure(6 months after the intervention ending)
- After intervention health-related quality of life measure(Immediately after the intervention.)
- 3 months after intervention health-related quality of life measure(3 months after the intervention ending)
- Baseline cancer-related fatigue(At baseline)
- 3 months after intervention cancer-related fatigue(3 months after the intervention ending)
- After intervention cancer-related fatigue(Immediately after the intervention.)
- 6 months after intervention cancer-related fatigue(6 months after the intervention ending)
- Baseline life satisfaction measure(At baseline)
- After intervention life satisfaction measure(Immediately after the intervention.)
- 3 months after intervention life satisfaction measure(3 months after the intervention ending)
- Baseline self-esteem(At baseline)
- After intervention self-esteem(Immediately after the intervention.)
- 3 months after intervention self-esteem measure(3 months after the intervention ending)
- 6 months after intervention life satisfaction measure(6 months after the intervention ending)
- 6 months after intervention self-esteem measure(6 months after the intervention ending)
- Baseline anxiety and depression perception measure(At baseline)
- After intervention anxiety and depression perception measure(Immediately after the intervention.)
- 3 months after intervention anxiety and depression perception measure(3 months after the intervention ending)
- 6 months after the intervention shoulder disability perception measure(6 months after the intervention ending)
- 6 months after intervention anxiety and depression perception measure(6 months after the intervention ending)
- Baseline Shoulder disability perception measure(At baseline)
- Baseline physical activity level measure(At baseline)
- After intervention shoulder disability perception measure(Immediately after the intervention.)
- 3 months after the intervention shoulder disability perception measure(3 months after the intervention ending)
- After intervention physical activity level measure(Immediately after the intervention.)
- 3 months after intervention physical activity level measure(3 months after the intervention ending)
- 3 months after intervention exercise motivation(3 months after the intervention ending)
- 6 months after intervention physical activity level measure(6 months after the intervention ending)
- Baseline exercise motivation(At baseline)
- After intervention exercise motivation(Immediately after the intervention.)
- 6 months after intervention exercise motivation(6 months after the intervention ending)
- Baseline kinesiophobia(At baseline)
- After intervention kinesiophobia(Immediately after the intervention.)
- 6 months after intervention kinesiophobia(6 months after the intervention ending)
- 3 months after intervention kinesiophobia(3 months after the intervention ending)