Different Resistance Training Intensity Prescription and Monitoring Methodologies: Effects on Strength, Body Composition, and Well-being in Survivors of Breast Cancer

May 27, 2026 updated by: Alberto Soriano-Maldonado, Universidad de Almeria

Effects of Different Methods of Prescription and Monitoring of Resistance Training Intensity on Muscle Strength, Body Composition, and Psychological Well-being in Survivors of Breast Cancer

The goal of this clinical trial is to compare the effects of three different methods of prescribing and monitoring resistance training intensity on muscle strength, body composition, quality of life, fatigue, anxiety, and depression in breast cancer survivors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Breast cancer survival rates have significantly increased in recent years, highlighting the importance of effective interventions to address the long-term consequences of cancer and its treatments. Breast cancer survivors often experience muscle weakness, changes in body composition, fatigue, and psychological distress, which can negatively impact their quality of life. Resistance training has been widely recognized as a safe and effective strategy to counteract these effects, improving muscle strength, body composition, and psychological well-being.

Despite its benefits, the optimal method for prescribing and monitoring resistance training intensity in breast cancer survivors remains unclear. Traditional methods based on one-repetition maximum (1RM) testing may not fully account for individual variations in fatigue and performance. Alternative approaches, such as load-velocity relationships, allow for more precise and real-time adjustments to training intensity, potentially optimizing outcomes.

This randomized controlled trial aims to compare the effects of three different methods of resistance training intensity prescription and monitoring on muscle strength, body composition, quality of life, fatigue, anxiety, and depression in breast cancer survivors. The findings will contribute to developing evidence-based exercise guidelines, enhancing rehabilitation strategies and overall well-being in this population.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Almeria
      • Almería, Almeria, Spain, 04120
        • University of Almeria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • To be >18 years old.
  • To have a breast cancer diagnosis.
  • To have finished chemotherapy, radiotherapy and/or surgery up to 10 years prior to the beginning of the study.

Exclusion Criteria:

  • To present metastatic breast cancer.
  • To have a planned surgery for breast reconstruction within three months after the start of the study.
  • To present any absolute contraindication for exercising.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Daily load-velocity-based training intensity adjustment
At the beginning of the training session, the one-repetition maximum (1RM) will be estimated based on the individual's load-velocity relationship, using the general velocity associated with the 1RM for the exercises included in the session. Additionally, during the training sessions, intensity will be monitored, and load will be adjusted in real time by movement velocity.
Behavioral: Daily load-velocity-based training intensity adjustment.
At the beginning of the training session, the one-repetition maximum (1RM) will be estimated based on the individual's load-velocity relationship, using the general velocity associated with the 1RM for the exercises included in the session. Additionally, during the training sessions, intensity will be monitored, and load will be adjusted in real time by movement velocity.
Experimental: Training intensity prescription based on an initial 1RM estimation using load-velocity relationship.
In the first training session, the one-repetition maximum (1RM) will be estimated based on the individual's load-velocity relationship, using the general velocity associated with the 1RM for the exercises included in the session. This 1RM will be used to prescribe exercise intensity throughout the intervention.
Behavioral: Training intensity prescription based on an initial 1RM estimation using load-velocity relationship
In the first training session, the one-repetition maximum (1RM) will be estimated based on the individual's load-velocity relationship, using the general velocity associated with the 1RM for the exercises included in the session. This 1RM will be used to prescribe exercise intensity throughout the intervention.
Experimental: Traditional training with intensity prescription based on 1RM testing.
The traditional training group will follow a training program using the traditionally employed methodology for assessing and prescribing training intensity in breast cancer survivors. This methodology is based on an initial 1RM estimation conducted through a 1RM test, which will be used to prescribe the training load throughout the intervention.
Behavioral: Traditional training with intensity prescription based on 1RM testing.
The traditional training group will follow a training program using the traditionally employed methodology for assessing and prescribing training intensity in breast cancer survivors. This methodology is based on an initial 1RM estimation conducted through a 1RM test, which will be used to prescribe the training load throughout the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscular strength
Time Frame: Change from baseline to week 8
The main variable of the present study will be muscle strength, assessed by determining peak isometric strength in the bench press and squat exercises using force platforms.
Change from baseline to week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handgrip strength
Time Frame: Change from baseline to week 8
Handgrip strength will be determined using a digital dynamometer (Model T.K.K.540; Takei Scientific Instruments Co, Ltd).
Change from baseline to week 8
Muscle function (5STS)
Time Frame: Change from baseline to week 8
Muscle function will be assessed using the 30-second sit-to-stand test. Additionally, the five-repetition sit-to-stand (5STS) test will be performed on force platforms, and the peak force of all repetitions will be recorded.
Change from baseline to week 8
Height (scale)
Time Frame: Baseline
Height will be determined using a scale (cm)
Baseline
Body weight (InBody 770)
Time Frame: Change from baseline to week 8
Body wieght (kg) will be determined using bioelectrical impedance analysis (InBody 770; InBody Co Ltd, Seoul, Korea).
Change from baseline to week 8
Total fat mass (InBody 770)
Time Frame: Change from baseline to week 8
Total fat mass (kg) will be determined using bioelectrical impedance analysis (InBody 770; InBody Co Ltd, Seoul, Korea).
Change from baseline to week 8
Fat percentage (InBody 770)
Time Frame: Change from baseline to week 8
body fat percentage (%) will be determined using bioelectrical impedance analysis (InBody 770; InBody Co Ltd, Seoul, Korea).
Change from baseline to week 8
Fat-free mass (InBody)
Time Frame: Change from baseline to week 8
Fat-free mass (kg) will be determined using bioelectrical impedance analysis (InBody 770; InBody Co Ltd, Seoul, Korea).
Change from baseline to week 8
Visceral fat mass level (InBody)
Time Frame: Change from baseline to week 8
Visceral fat mass level (U) will be determined using bioelectrical impedance analysis (InBody 770; InBody Co Ltd, Seoul, Korea).
Change from baseline to week 8
Health-related quality of life (FACT-B)
Time Frame: Change from baseline to week 8
Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. The global score ranges from 0 to 148 where higher scores indicate better quality of life.
Change from baseline to week 8
Cancer-related fatigue (FACIT-F)
Time Frame: Change from baseline to week 8
Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire. The score ranges from 0 to 52, where higher scores indicate lower levels of fatigue.
Change from baseline to week 8
Anxiety and depression (HADS)
Time Frame: Change from baseline to week 8
Anxiety and depression will be determined using the Hospital Anxiety and Depression Scale (HADS). Scores range from 0 to 21 for both HADS-A (Anxiety) and HADS-D (Depression) subscales, where higher scores indicate more severe symptoms of anxiety or depression.
Change from baseline to week 8
Patient global impression of change
Time Frame: Week 8
Patient global impression of change after the intervention will be evaluated at the end of the trial using a single Likert-type question.
Week 8

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of perceived exertion (RPE)
Time Frame: Through intervention completion, during 8 weeks. From day 1 to day 24.
The rate of perceived exertion during the whole training session will be assessed at the end of each of the 24 intervention session using the modified Borg Scale (0-10) where higher scores mean higher perceived exertion.
Through intervention completion, during 8 weeks. From day 1 to day 24.
Mood (Feeling Scale)
Time Frame: Through intervention completion, during 8 weeks. From day 1 to day 24.
The mood perceived by the participants at the end of the session will be measured at the end of each of the 24 intervention session using the Feeling Scale. The scale ranges from -5 to 5, where higher scores indicate positive affect toward physical activity.
Through intervention completion, during 8 weeks. From day 1 to day 24.
Perceived fatigue (VAS-F)
Time Frame: Through intervention completion, during 8 weeks. From day 1 to day 24.
The fatigue perceived by the participants at the end of the session will be assessed at the end of each of the 24 intervention session using a visual analog scale for fatigue (VAS-F). The scale ranges from 0 to 10, where higher scores indicate greater fatigue.
Through intervention completion, during 8 weeks. From day 1 to day 24.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Collaborators

Patronato Municipal de Deportes de Almería, Spain

Investigators

  • Principal Investigator: Alberto Soriano-Maldonado, Universidad de Almeria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2025

Primary Completion (Actual)

December 19, 2025

Study Completion (Actual)

December 19, 2025

Study Registration Dates

First Submitted

March 28, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFICAN/04/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual participant data will be shared once the study is finalized and the main results are published. IPD can be obtained by contacting the responsible party.

IPD Sharing Time Frame

One year (12 months) after study completion and once the results have been published.

IPD Sharing Access Criteria

The PI must be contacted and a consensus must be reached on potential co-authorship.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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