Clinical trial NCT05040867: Exercise Prescription Guided by Heart Rate Variability in Breast Cancer Patients
Official title: Effects of Physical Exercise, and Its Prescription Guided by Heart Rate Variability, on the Cardiotoxicity, Physical and Psychological Health of Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Cardiotoxicity
Autonomic Imbalance
Keywords: Physical exercise
Heart rate variability
Strength training
Cardiovascular training
Cardiotoxicity changes
Cancer patients
Cancer-related side effects
High-intensity training
Lead sponsor: GO fit Lab- Ingesport
Sponsor class: NETWORK
Collaborators: name: Marqués de Valdecilla University Hospital
name: Center for Sport Studies, Rey Juan Carlos University
First posted: 2021-09-10
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Baseline Troponin
timeFrame: At baseline
measure: After intervention Troponin
timeFrame: Immediately after the intervention
measure: 3 months after intervention Troponin
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention Troponin
timeFrame: 6 months after the intervention ending
measure: Baseline Brain Natriuretic Peptide
timeFrame: At baseline
measure: After intervention Brain Natriuretic Peptide
timeFrame: Immediately after the intervention
measure: 3 months after intervention Brain Natriuretic Peptide
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention Brain Natriuretic Peptide
timeFrame: 6 months after the intervention ending
measure: Baseline left ventricular systolic and diastolic volume
timeFrame: At Baseline
measure: After intervention left ventricular systolic and diastolic volume
timeFrame: Immediately after the intervention ending
measure: 3 months after intervention left ventricular systolic and diastolic volume
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention left ventricular systolic and diastolic volume
timeFrame: 6 months after the intervention ending
measure: Baseline left ventricular ejection fraction
timeFrame: At baseline
measure: After intervention left ventricular ejection fraction
timeFrame: Immediately after the intervention
measure: 3 months after intervention left ventricular ejection fraction
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention left ventricular ejection fraction
timeFrame: 6 months after the intervention ending
measure: Baseline time domain heart rate variability measures
timeFrame: At baseline
measure: After intervention time-domain heart rate variability measures
timeFrame: Immediately after the intervention
measure: 3 months after intervention time-domain heart rate variability measures
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention time-domain heart rate variability measures
timeFrame: 6 months after the intervention ending
measure: During intervention time-domain heart rate variability measures
timeFrame: During the intervention ending
measure: Baseline frequency domain heart rate variability measures
timeFrame: At baseline
measure: After intervention frequency domain heart rate variability measures
timeFrame: Immediately after the intervention
measure: 3 months after intervention frequency domain heart rate variability measures
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention frequency domain heart rate variability measures
timeFrame: 6 months after the intervention ending
measure: During intervention frequency domain heart rate variability measures
timeFrame: During the intervention
Secondary outcomes:
measure: Baseline heart rate rhyme
timeFrame: At baseline
measure: After intervention heart rate rhyme
timeFrame: Immediately after the intervention
measure: 3 months after intervention heart rate rhyme
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention heart rate rhyme
timeFrame: 6 months after the intervention
measure: Baseline tumor necrosis factor
timeFrame: At baseline
measure: After intervention tumor necrosis factor
timeFrame: Immediately after the intervention
measure: 3 months after intervention tumor necrosis factor
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention tumor necrosis factor
timeFrame: 6 months after the intervention ending
measure: Baseline interleukins measurement
timeFrame: At baseline
measure: After intervention interleukins measurement
timeFrame: Immediately after the intervention.
measure: 3 months after intervention interleukins measurement
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention interleukins measurement
timeFrame: 6 months after the intervention ending
measure: Baseline C-reactive protein measure
timeFrame: At baseline
measure: After intervention C-reactive protein measure
timeFrame: Immediately after the intervention.
measure: 3 months after intervention C-reactive protein measure
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention C-reactive protein measure
timeFrame: 6 months after the intervention ending
measure: Baseline monocyte chemotactic protein measure
timeFrame: At baseline
measure: After intervention monocyte chemotactic protein measure
timeFrame: Immediately after the intervention.
measure: 3 months after intervention monocyte chemotactic protein measure
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention monocyte chemotactic protein measure
timeFrame: 6 months after the intervention ending
measure: Baseline glucose measure
timeFrame: At baseline
measure: After intervention glucose measure
timeFrame: Immediately after the intervention.
measure: 3 months after intervention glucose measure
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention glucose measure
timeFrame: 6 months after the intervention ending
measure: Baseline cholesterol measure
timeFrame: At baseline
measure: After intervention cholesterol measure
timeFrame: Immediately after the intervention.
measure: 3 months after intervention cholesterol measure
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention cholesterol measure
timeFrame: 6 months after the intervention ending
measure: Baseline blood pressure measures
timeFrame: At baseline
measure: After intervention blood pressure measures
timeFrame: Immediately after the intervention.
measure: 3 months after intervention blood pressure measures
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention blood pressure measures
timeFrame: 6 months after the intervention ending
measure: Baseline body composition weight measures
timeFrame: At baseline
measure: After intervention body composition weight measures
timeFrame: Immediately after the intervention.
measure: 3 months after intervention body composition weight measures
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention body composition weight measures
timeFrame: 6 months after the intervention ending
measure: Baseline body composition percentages measures
timeFrame: At baseline
measure: After intervention body composition percentages measures
timeFrame: Immediately after the intervention.
measure: 3 months after intervention body composition percentages measures
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention body composition percentages measures
timeFrame: 6 months after the intervention ending
measure: Baseline body water measures
timeFrame: At baseline
measure: After intervention body water measures
timeFrame: Immediately after the intervention.
measure: 3 months after intervention body water measures
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention body water measures
timeFrame: 6 months after the intervention ending
measure: Baseline anthropometric measures
timeFrame: At baseline
measure: After intervention anthropometric measures
timeFrame: Immediately after the intervention.
measure: 3 months after intervention anthropometric measures
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention anthropometric measures
timeFrame: 6 months after the intervention ending
measure: Baseline cardiorespiratory fitness
timeFrame: At baseline
measure: After intervention cardiorespiratory fitness
timeFrame: Immediately after the intervention.
measure: 3 months after intervention cardiorespiratory fitness
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention cardiorespiratory fitness
timeFrame: 6 months after the intervention ending
measure: Baseline measurement of lower-body strength endurance
timeFrame: At baseline
measure: After intervention measurement of lower-body strength endurance
timeFrame: Immediately after the intervention.
measure: 3 months after intervention measurement of lower-body strength endurance
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention measurement of lower-body strength endurance
timeFrame: 6 months after the intervention ending
measure: Baseline maximal strength
timeFrame: At baseline
measure: After intervention maximal strength
timeFrame: Immediately after the intervention.
measure: 3 months after intervention maximal strength
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention maximal strength
timeFrame: 6 months after the intervention ending
measure: Baseline vertical applied force
timeFrame: At baseline
measure: After intervention vertical applied force
timeFrame: Immediately after the intervention.
measure: 3 months intervention vertical applied force
timeFrame: 3 months after the intervention ending
measure: 6 months intervention vertical applied force
timeFrame: 6 months after the intervention ending
measure: Baseline measurement of upper body strength endurance
timeFrame: At baseline
measure: After intervention measurement of upper body strength endurance
timeFrame: Immediately after the intervention.
measure: 3 months after intervention measurement of upper body strength endurance
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention measurement of upper body strength endurance
timeFrame: 6 months after the intervention ending
measure: Baseline maximal upper body strength
timeFrame: At baseline
measure: After intervention maximal upper body strength
timeFrame: Immediately after the intervention.
measure: 3 months after intervention maximal upper body strength
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention maximal upper body strength
timeFrame: 6 months after the intervention ending
measure: Baseline measurement of agility and dynamic balance
timeFrame: At baseline
measure: After intervention measurement of agility and dynamic balance
timeFrame: Immediately after the intervention.
measure: 3 months after intervention measurement of agility and dynamic balance
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention measurement of agility and dynamic balance
timeFrame: 6 months after the intervention ending
measure: Baseline static monopodal balance
timeFrame: At baseline
measure: After intervention static monopodal balance
timeFrame: Immediately after the intervention.
measure: 3 months after intervention static monopodal balance
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention static monopodal balance
timeFrame: 6 months after the intervention ending
measure: Baseline measurement of upper body flexibility
timeFrame: At baseline
measure: After intervention measurement of upper body flexibility
timeFrame: Immediately after the intervention.
measure: 3 months after intervention measurement of upper body flexibility
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention measurement of upper body flexibility
timeFrame: 6 months after the intervention ending
measure: Baseline measurement of lower body flexibility
timeFrame: At baseline
measure: After intervention measurement of lower body flexibility
timeFrame: Immediately after the intervention.
measure: 3 months after intervention measurement of lower body flexibility
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention measurement of lower body flexibility
timeFrame: 6 months after the intervention ending
measure: Baseline health-related quality of life measure
timeFrame: At baseline
measure: After intervention health-related quality of life measure
timeFrame: Immediately after the intervention.
measure: 3 months after intervention health-related quality of life measure
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention health-related quality of life measure
timeFrame: 6 months after the intervention ending
measure: Baseline cancer-related fatigue
timeFrame: At baseline
measure: After intervention cancer-related fatigue
timeFrame: Immediately after the intervention.
measure: 3 months after intervention cancer-related fatigue
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention cancer-related fatigue
timeFrame: 6 months after the intervention ending
measure: Baseline life satisfaction measure
timeFrame: At baseline
measure: After intervention life satisfaction measure
timeFrame: Immediately after the intervention.
measure: 3 months after intervention life satisfaction measure
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention life satisfaction measure
timeFrame: 6 months after the intervention ending
measure: Baseline self-esteem
timeFrame: At baseline
measure: After intervention self-esteem
timeFrame: Immediately after the intervention.
measure: 3 months after intervention self-esteem measure
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention self-esteem measure
timeFrame: 6 months after the intervention ending
measure: Baseline anxiety and depression perception measure
timeFrame: At baseline
measure: After intervention anxiety and depression perception measure
timeFrame: Immediately after the intervention.
measure: 3 months after intervention anxiety and depression perception measure
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention anxiety and depression perception measure
timeFrame: 6 months after the intervention ending
measure: Baseline Shoulder disability perception measure
timeFrame: At baseline
measure: After intervention shoulder disability perception measure
timeFrame: Immediately after the intervention.
measure: 3 months after the intervention shoulder disability perception measure
timeFrame: 3 months after the intervention ending
measure: 6 months after the intervention shoulder disability perception measure
timeFrame: 6 months after the intervention ending
measure: Baseline physical activity level measure
timeFrame: At baseline
measure: After intervention physical activity level measure
timeFrame: Immediately after the intervention.
measure: 3 months after intervention physical activity level measure
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention physical activity level measure
timeFrame: 6 months after the intervention ending
measure: Baseline exercise motivation
timeFrame: At baseline
measure: After intervention exercise motivation
timeFrame: Immediately after the intervention.
measure: 3 months after intervention exercise motivation
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention exercise motivation
timeFrame: 6 months after the intervention ending
measure: Baseline kinesiophobia
timeFrame: At baseline
measure: After intervention kinesiophobia
timeFrame: Immediately after the intervention.
measure: 3 months after intervention kinesiophobia
timeFrame: 3 months after the intervention ending
measure: 6 months after intervention kinesiophobia
timeFrame: 6 months after the intervention ending
Other outcomes:
Locations:
city: Santander
country: Spain
facility: GOfit
state: Cantabria
Study officials:
References: