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

NCT06940310 | Recruiting

• 1 other identifier: EFICAN/04/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

resistance training; muscular strength; health-related quality of life; exercise intensity; breast malignancy

Outcome Measures

Primary Outcomes (1)

• Muscular strength

  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 Outcomes (12)

• Handgrip strength

  Change from baseline to week 8

• Muscle function (5STS)

  Change from baseline to week 8

• Height (scale)

  Baseline

• Body weight (InBody 770)

  Change from baseline to week 8

• Total fat mass (InBody 770)

  Change from baseline to week 8

Other Outcomes (3)

• Rate of perceived exertion (RPE)

  Through intervention completion, during 8 weeks. From day 1 to day 24.

• Mood (Feeling Scale)

  Through intervention completion, during 8 weeks. From day 1 to day 24.

• Perceived fatigue (VAS-F)

  Through intervention completion, during 8 weeks. From day 1 to day 24.

Study Arms (3)

Daily load-velocity-based training intensity adjustment

EXPERIMENTAL

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.

Training intensity prescription based on an initial 1RM estimation using load-velocity relationship.

EXPERIMENTAL

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

Traditional training with intensity prescription based on 1RM testing.

EXPERIMENTAL

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.

Interventions

Daily load-velocity-based training intensity adjustment. BEHAVIORAL

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.

Daily load-velocity-based training intensity adjustment

Training intensity prescription based on an initial 1RM estimation using load-velocity relationship BEHAVIORAL

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.

Training intensity prescription based on an initial 1RM estimation using load-velocity relationship.

Traditional training with intensity prescription based on 1RM testing. BEHAVIORAL

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.

Traditional training with intensity prescription based on 1RM testing.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead
• Patronato Municipal de Deportes de Almería, Spain: collaborator

Study Sites (1)

University of Almeria

Almería, Almeria, 04120, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alberto Soriano-Maldonado

  Universidad de Almeria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Soriano-Maldonado

CONTACT

950015550; asoriano@ual.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 23, 2025
• Study Start: May 9, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: One year (12 months) after study completion and once the results have been published.
• Access Criteria: The PI must be contacted and a consensus must be reached on potential co-authorship.

Locations

ES (1)