Plyometric Strength-Endurance Exercise in Breast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Vigo
About this trial
This study aims to compare an adapted plyometric strength-endurance exercise program with conventional strength training in women who are breast cancer survivors or currently undergoing treatment and who participate in provincial support associations. The goal is to determine whether a targeted plyometric intervention can provide additional benefits in physical and mental health outcomes.
Using a cluster-randomized clinical trial design, the study will assess indicators such as functional capacity, muscle strength, fatigue levels, symptoms related to lymphedema, and overall quality of life. The findings are expected to contribute to a better understanding of how structured exercise programs can support recovery, physical function, and well-being in women affected by breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 18 years or older.
Prior diagnosis of breast cancer.
History of mastectomy, including unilateral procedures, total breast surgery, or breast-conserving surgery.
Completion of postoperative chemotherapy or radiotherapy, when indicated.
Disqualifiers
Active metastasis to other organs or tissues (e.g., liver, kidney, lung, brain) or stage IV cancer that prevents safe participation in the therapeutic exercise program.
Current diagnosis of cardiovascular, respiratory, neuromuscular, or musculoskeletal diseases that contraindicate physical exercise or impair safe completion of the program.
Major surgery within the previous 6 months without medical clearance to resume physical activity.
Cognitive impairment or mental health conditions that limit comprehension of instructions or safe engagement in the intervention.
Trial design
Design model
Parallel
Treatments tested in this trial
Plyometric Strength-Endurance Training
Other interventionParticipants in the experimental group will take part in an adapted plyometric strength-endurance training program delivered through supervised 60-minute sessions, twice per week, over a 12-week period (24 sessions total). A minimum rest interval of 48 hours will be maintained between sessions. The frequency and duration of the intervention follow the recommendations of the National Strength and Conditioning Association (NSCA) for safe implementation of plyometric and strength-endurance exercise in adult populations.
Conventional Strength Training
Other interventionParticipants assigned to the control group will perform a conventional strength training program. This program has been designed as an active and structured intervention to allow a meaningful comparison with the effects of the plyometric training implemented in the experimental group. The exercise circuit will include functional movements aimed at global strengthening, with an emphasis on multi-joint patterns that promote transfer of improvements to activities of daily living.
Treatment groups
51 Participants
are divided into 2 treatment groupsGroup A: Plyometric Strength-Endurance Training ProgramExperimental treatment 1 intervention
Group B: Conventional Strength TrainingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Quality of life (Breast Cancer-Specific Quality of Life)
EORTC QLQ-BR42: European Organisation for Research and Treatment of Cancer (EORTC) to assess breast cancer-specific quality of life. Description: The EORTC QLQ-BR42 is a validated 42-item questionnaire designed to assess breast cancer-specific quality of life. It evaluates physical, emotional, and functional well-being, as well as symptoms and treatment-related side effects relevant to contemporary breast cancer therapies. The measure covers domains such as body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms. Scoring: Items are scored according to the EORTC scoring manual. Scores are linearly transformed to a 0-100 scale. Higher scores on functional scales indicate better functioning; higher scores on symptom scales indicate greater symptom burden.
Time frame
From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up periodSecondary outcomes
1
Cardiorespiratory capacity
6-Minute Walk Test (6MWT) Description: The Six-Minute Walk Test is a standardized assessment of cardiorespiratory capacity that measures the total distance walked (in meters) over a six-minute period at a self-paced speed. It reflects functional exercise tolerance and global physical endurance. Score Range: Minimum possible score: 0 meters Maximum possible score: No fixed upper limit (performance-dependent; healthy individuals may reach 300-700 meters) Interpretation: Higher scores indicate a better outcome, reflecting greater cardiorespiratory capacity.
Time frame
From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period2
Cancer-related fatigue
FACIT-F (Functional Assessment of Chronic Illness Therapy - Fatigue) Description: The Functional Assessment of Chronic Illness Therapy - Fatigue Subscale (FACIT-Fatigue) is a validated patient-reported questionnaire assessing cancer-related fatigue and its impact on daily functioning. It contains 13 items, each rated on a Likert scale from 0 ("not at all") to 4 ("very much"). Score Range: Minimum possible score: 0 points (indicates the worst fatigue) Maximum possible score: 52 points (indicates the least fatigue) Interpretation: Higher scores indicate a better outcome, representing less fatigue and better functional well-being.
Time frame
From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period3
Mobility and range of motion
Goniometry and flexibility testing Description: Goniometric and flexibility tests will be used to assess joint mobility of the upper and lower limbs and trunk. Goniometry quantifies joint range of motion in degrees using a standardized instrument (goniometer), while flexibility tests measure muscle and soft-tissue extensibility. These tests evaluate functional mobility relevant to daily activities. Score Range: Minimum: 0 degrees (no active movement) Maximum: varies by joint Interpretation:Higher scores indicate better mobility and joint range of motion.
Time frame
From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period4
Muscle strength
Hand-held dynamometry (MicroFET II - Maximal isometric strength) Description: Maximal isometric strength will be assessed using a hand-held dynamometer (MicroFET II). This device measures force output (in Newtons or kilograms-force) during standardized resisted movements of the upper limb. Score Range: Minimum: 0 (no measurable force) Maximum: device-dependent; MicroFET II typically measures up to 300 pounds-force (≈1334 N), though functional values are lower in clinical practice. Interpretation: Higher scores indicate a better outcome, reflecting greater muscular strength.
Time frame
From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up periodSponsors and contacts
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Source ClinicalTrials.gov
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