Clinical trial NCT06940310: Different Resistance Training Intensity Prescription and Monitoring Methodologies: Effects on Strength, Body Composition, and Well-being in Survivors of Breast Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: resistance training
muscular strength
health-related quality of life
exercise intensity
breast malignancy
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
Collaborators: name: Patronato Municipal de Deportes de Almería, Spain
First posted: 2025-04-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Muscular strength
timeFrame: Change from baseline to week 8
Secondary outcomes:
measure: Handgrip strength
timeFrame: Change from baseline to week 8
measure: Muscle function (5STS)
timeFrame: Change from baseline to week 8
measure: Height (scale)
timeFrame: Baseline
measure: Body weight (InBody 770)
timeFrame: Change from baseline to week 8
measure: Total fat mass (InBody 770)
timeFrame: Change from baseline to week 8
measure: Fat percentage (InBody 770)
timeFrame: Change from baseline to week 8
measure: Fat-free mass (InBody)
timeFrame: Change from baseline to week 8
measure: Visceral fat mass level (InBody)
timeFrame: Change from baseline to week 8
measure: Health-related quality of life (FACT-B)
timeFrame: Change from baseline to week 8
measure: Cancer-related fatigue (FACIT-F)
timeFrame: Change from baseline to week 8
measure: Anxiety and depression (HADS)
timeFrame: Change from baseline to week 8
measure: Patient global impression of change
timeFrame: Week 8
Other outcomes:
measure: Rate of perceived exertion (RPE)
timeFrame: Through intervention completion, during 8 weeks. From day 1 to day 24.
measure: Mood (Feeling Scale)
timeFrame: Through intervention completion, during 8 weeks. From day 1 to day 24.
measure: Perceived fatigue (VAS-F)
timeFrame: Through intervention completion, during 8 weeks. From day 1 to day 24.
Locations:
city: Almeria
country: Spain
facility: University of Almeria
Study officials:
affiliation: Universidad de Almeria
name: Alberto Soriano-Maldonado
role: PRINCIPAL_INVESTIGATOR
References: