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Completed

NCT Number: NCT06940310

Different Resistance Training Intensity Prescription and Monitoring Methodologies: Effects on Strength, Body Composition, and 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Almeria

Almería, Almeria, 04120, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. Height (scale)

    Time frame: Baseline

    Height will be determined using a scale (cm)

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  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).

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Collaborators

  • Patronato Municipal de Deportes de Almería, Spain

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 23, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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