NCT05040867

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

September 13, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

September 10, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

August 24, 2021

Last Update Submit

September 1, 2021

Conditions

Breast CancerCardiotoxicityAutonomic Imbalance

Keywords

Physical exerciseHeart rate variabilityStrength trainingCardiovascular trainingCardiotoxicity changesCancer patientsCancer-related side effectsHigh-intensity training

Outcome Measures

Primary Outcomes (26)

  • Baseline Troponin

    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.

    At baseline

  • After intervention Troponin

    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.

    Immediately after the intervention

  • 3 months after intervention Troponin

    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 the intervention ending

  • 6 months after intervention Troponin

    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 the intervention ending

  • Baseline Brain Natriuretic Peptide

    A haemogram will be carried out to analyse patients' BNP to assess their cardiotoxicity levels. BNP results will be reported in pg/ml.

    At baseline

  • After intervention Brain Natriuretic Peptide

    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.

    Immediately after the intervention

  • 3 months after intervention Brain Natriuretic Peptide

    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 the intervention ending

  • 6 months after intervention Brain Natriuretic Peptide

    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.

    6 months after the intervention ending

  • Baseline left ventricular systolic and diastolic volume

    An echocardiogram will be performed to measure left ventricular systolic and diastolic volume in mL.

    At Baseline

  • After intervention left ventricular systolic and diastolic volume

    An echocardiogram will be performed to measure left ventricular systolic and diastolic volume in mL and it changes after the intervention.

    Immediately after the intervention ending

  • 3 months after intervention left ventricular systolic and diastolic volume

    An echocardiogram will be performed to measure left ventricular systolic and diastolic volume in mL and it changes 3 months after the intervention.

    3 months after the intervention ending

  • 6 months after intervention left ventricular systolic and diastolic volume

    An echocardiogram will be performed to measure left ventricular systolic and diastolic volume in mL and it changes 6 months after the intervention.

    6 months after the intervention ending

  • Baseline left ventricular ejection fraction

    By an echocardiogram, patients' % of LVEF will be assessed due to its possible modification caused by cardiotoxicity.

    At baseline

  • After intervention left ventricular ejection fraction

    By an echocardiogram, patients' % of LVEF will be assessed to measure its results and its change after the intervention.

    Immediately after the intervention

  • 3 months after intervention left ventricular ejection fraction

    By an echocardiogram, patients' % of LVEF will be assessed to measure its results and its change 3 months after the intervention.

    3 months after the intervention ending

  • 6 months after intervention left ventricular ejection fraction

    By an echocardiogram, patients' % of LVEF will be assessed to measure its results and its change 6 months after the intervention.

    6 months after the intervention ending

  • Baseline time domain heart rate variability measures

    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.

    At baseline

  • After intervention time-domain heart rate variability measures

    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.

    Immediately after the intervention

  • 3 months after intervention time-domain heart rate variability measures

    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.

    3 months after the intervention ending

  • 6 months after intervention time-domain heart rate variability measures

    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.

    6 months after the intervention ending

  • During intervention time-domain heart rate variability measures

    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).

    During the intervention ending

  • Baseline frequency domain heart rate variability measures

    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.

    At baseline

  • After intervention frequency domain heart rate variability measures

    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.

    Immediately after the intervention

  • 3 months after intervention frequency domain heart rate variability measures

    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.

    3 months after the intervention ending

  • 6 months after intervention frequency domain heart rate variability measures

    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.

    6 months after the intervention ending

  • During intervention frequency domain heart rate variability measures

    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)

    During the intervention

Secondary Outcomes (124)

  • 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

  • +119 more secondary outcomes

Study Arms (3)

Control group (CG)

NO INTERVENTION

Participants will continue with their daily life and usual care.

Traditional periodization exercise group (TEG)

EXPERIMENTAL

Participants will participate in a physical exercise program with a preplanned intensity progression.

Other: Physical exercise program

Heart Rate Variability exercise group (HRVG)

EXPERIMENTAL

Participants will participate in a physical exercise program guide by participants' daily heart rate variability to plan the intensity progression.

Other: Physical exercise program

Interventions

Physical exercise programOTHER

The physical exercise programme will last 16 weeks where participants will do three weekly sessions of 60 minutes, approximately. In these training sessions, cardiovascular and strength components will be worked out, planned from moderate to high intensity in the TEG and unique high intensity in the HRVG. The training programme will be divided into three mesocycles from neuromuscular adaptation to reach, in last period, the highest loads and cardiovascular levels. Each session will include a warm-up, a main part and a cool-down with stretching and mobility exercises. The difference between the interventions of the HRVG and TEG will be in the planning of the intensity of the cardiovascular exercises and the weight to be lifted in the strength exercises. The first session of both programmes will have the same intensity but depending on how the heart rate variability of the HRVG patients reacts to, the weight and the intensity will be individualised each day.

Heart Rate Variability exercise group (HRVG)Traditional periodization exercise group (TEG)

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Being undergoing radiotherapy treatment or scheduled for surgery
  • Having metastasic cancer
  • Not having any serious psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GOfit

Santander, Cantabria, 39011, Spain

Location

Related Publications (1)

  • Lavin-Perez AM, Collado-Mateo D, Hinojo Gonzalez C, de Juan Ferre A, Ruisanchez Villar C, Mayo X, Jimenez A. High-intensity exercise prescription guided by heart rate variability in breast cancer patients: a study protocol for a randomized controlled trial. BMC Sports Sci Med Rehabil. 2023 Mar 8;15(1):28. doi: 10.1186/s13102-023-00634-2.

    PMID: 36890601DERIVED

MeSH Terms

Conditions

Breast NeoplasmsCardiotoxicityMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and InjuriesBehavior

Central Study Contacts

Ana Myriam Lavín-Pérez

CONTACT

695932730am.lavin.2018@alumnos.urjc.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2021

First Posted

September 10, 2021

Study Start

September 13, 2021

Primary Completion

July 30, 2022

Study Completion

September 20, 2022

Last Updated

September 10, 2021

Record last verified: 2021-08

Locations

ES(1)