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| ID | Type | Description | Link |
|---|---|---|---|
| 2025/001 | Other Identifier | COFIGA |
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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.
Breast cancer is the most common malignancy among women worldwide. Despite significant advances in diagnosis and treatment that have improved survival rates, many patients and survivors continue to experience physical and psychological impairments that negatively affect their quality of life. Historically, intense or repetitive upper-limb exercise was discouraged due to concerns about triggering or worsening lymphedema. However, current evidence supports supervised therapeutic exercise as both safe and effective for this population. Strength training, in particular, has demonstrated benefits in muscle mass, physical function, bone health, fatigue reduction, and emotional well-being.
Most existing research has focused on conventional strength training programs, leaving a gap in the evidence regarding more dynamic approaches, such as strength-endurance training involving plyometric exercises. Research on plyometrics within oncology remains limited and has been conducted primarily in pediatric populations, such as survivors of childhood leukemia or children with neurofibromatosis type 1. Nevertheless, plyometric training-traditionally used in athletic performance and in patients with neurological or musculoskeletal conditions-may offer significant therapeutic potential for women living with or recovering from breast cancer.
Plyometric exercises are known to enhance muscular power, balance, proprioception, and neuromuscular control, all of which are essential for restoring functional capacity and independence. Their dynamic, progressive nature may also support greater motivation and adherence, potentially translating into improvements in mental health, self-esteem, and body image.
In summary, plyometric-based strength-endurance training represents an innovative and promising approach to improving quality of life, functional performance, and overall well-being in women who are survivors of breast cancer or currently undergoing treatment. This study aims to address the existing evidence gap by evaluating the therapeutic effects of an adapted plyometric program compared with conventional strength training within a controlled clinical trial framework.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plyometric Strength-Endurance Training Program | Experimental | Participants 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 the safe implementation of plyometric and strength-endurance exercise in adult populations. A total battery of 22 plyometric exercises has been designed based on previous scientific literature in which plyometric movements were adapted for individuals with various clinical conditions. These exercises are progressively structured to ensure safe neuromuscular adaptation, gradual increases in intensity, and individualized progression according to each participant's tolerance and functional capabilities. |
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| Conventional Strength Training | Active Comparator | Participants 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. The program will be organized as a circuit of strength exercises performed after the warm-up phase and before the cool-down phase, delivered over a 12-week period through supervised 60-minute sessions held twice per week with at least 48 hours of rest between sessions to allow for adequate muscular recovery. Training volume will progress from 1-3 sets of 8 repetitions in weeks 1-2, increasing to 12-14 reps, and up to 4 sets in the final week based on tolerance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plyometric Strength-Endurance Training | Other | Participants 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoana Gonzalez-Gonzalez, PhD | Contact | (+34) 986 801767 | yoana@uvigo.gal | |
| Gloria María Cascallar Cascallar, Graduate | Contact | gloria.maria.cascallar.cascallar@sergas.es |
| Name | Affiliation | Role |
|---|---|---|
| Yoana Gonzalez Gonzalez, PhD | University ofVigo | Principal Investigator |
| Gloria M Cascallar Cascallar, Graduate | SERGAS (Servicio galego de Saúde), Galician Health Service, Spanish Social Security System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physiotherapy | Pontevedra | Galicia | 36001 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30658629 | Background | Paulo TRS, Rossi FE, Viezel J, Tosello GT, Seidinger SC, Simoes RR, de Freitas R Jr, Freitas IF Jr. The impact of an exercise program on quality of life in older breast cancer survivors undergoing aromatase inhibitor therapy: a randomized controlled trial. Health Qual Life Outcomes. 2019 Jan 18;17(1):17. doi: 10.1186/s12955-019-1090-4. | |
| 33219115 |
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The individual participant data (IPD) from this study will not be shared.
Data will remain confidential and will be used exclusively for the purposes of this research project. The decision not to share IPD is based on the following considerations:
The dataset contains sensitive personal and health information from oncology patients, and sharing it could compromise participant privacy.
Participants did not consent to external sharing of their individual data beyond the research team.
The study protocol prioritizes strict confidentiality in accordance with European data protection regulations (GDPR) and institutional policies.
The size and nature of the dataset increase the risk of re-identification, even after de-identification procedures.
For these reasons, no individual-level data will be made publicly available.
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| Conventional Strength Training | Other | Participants 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. |
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| From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period |
| 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. | From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period |
| 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. | From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period |
| 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. | From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period |
| Proprioception | Outcome measure: Joint position sense and force-matching tests Description: Proprioception will be evaluated using joint position sense testing (ability to reproduce specific joint angles) and force-matching tasks (ability to replicate a target force level). These tests assess neuromuscular control, sensorimotor acuity, and accuracy in joint and force detection. Score Range: Joint position sense: error values typically expressed in degrees (°). Minimum error: 0° (perfect accuracy) Maximum error: no fixed upper limit; depends on test range Force-matching: error expressed as difference from target force. Minimum error: 0 (perfect accuracy) Maximum: no predefined limit Interpretation: Lower error values indicate a better outcome (greater proprioceptive accuracy). | From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period |
| Upper limb functionality | Outcome measure 1: Disabilities of the arm, shoulder and hand questionnaire (DASH) Description: The DASH is a 30-item patient-reported outcome measure assessing physical function and disability of the upper limb. It evaluates difficulty performing daily activities, symptom severity, and functional limitations. Score Range: Minimum: 0 (no disability → best outcome) Maximum: 100 (severe disability → worst outcome) Interpretation: Higher scores indicate a worse outcome (greater disability). Outcome Measure 2: Constant-Murley shoulder score Description: The Constant-Murley Score is a clinician-reported composite measure evaluating shoulder function through four domains: pain, daily living activities, range of motion, and strength. Total score ranges from 0 to 100. Score Range: Minimum: 0 (worst shoulder function) Maximum: 100 (normal shoulder function) Interpretation: Higher scores indicate a better outcome (greater shoulder function). | From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period |
| Presence of lymphedema | Outcome measure: Presence of lymphedema (Yes/No), symptom severity, and limb circumference measurements. Description: Lymphedema will be assessed through a combination of:
Score Range: Visual analog scale: 0 (no symptoms) to 10 (worst symptoms). Circumference: no fixed minimum/maximum, values recorded in centimeters. Interpretation: Higher symptom scores and larger circumference values indicate worse lymphedema. | From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period |
| Sleep quality | Outcome measure: Pittsburgh Sleep Quality Index (PSQI) Description: The PSQI evaluates overall sleep quality across seven components (sleep latency, duration, efficiency, disturbances, etc.). The questionnaire includes 19 items. Score Range: Minimum: 0 Maximum: 21 Higher scores = worse sleep quality. Interpretation: A global score > 5 typically indicates poor sleep quality. | From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period |
| Kinesiophobia | Tampa Scale for Kinesiophobia - 11-item Version (TSK-11) Description: The TSK-11 assesses the fear of movement or reinjury, using 11 Likert-scale items rated from 1 (strongly disagree) to 4 (strongly agree). Score Range: Minimum: 11 Maximum: 44 Higher scores indicate greater fear of movement. Interpretation: Higher scores = worse outcome. | From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period |
| Enjoyment of physical activity | Measure 1: Enjoyment of physical activity (Physical Activity Enjoyment Scale - PACES-18) Description: 18-item validated scale assessing enjoyment of physical activity; items rated on a 7-point Likert scale. Score Range: Min: 18 (lowest enjoyment) Max: 126 (highest enjoyment) Interpretation: Higher scores = greater enjoyment of physical activity. Measure 2: Leisure-Time Physical Activity (Leisure-Time Physical Activity Questionnaire) Description: Self-reported weekly minutes of moderate and vigorous physical activity performed during leisure time. Score Range: Min: 0 minutes/week Max: No fixed upper limit Interpretation: Higher scores = greater leisure-time physical activity (better outcome). | From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period |
| Exercise adherence rate | Description: Adherence will be calculated using the formula: (Number of sessions completed / Number of scheduled sessions) × 100. Score Range: Minimum: 0% Maximum: 100% Interpretation: Higher percentages indicate better adherence. | From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period |
| Intervention acceptability | Custom Likert-Scale Acceptability Questionnaire (Ad Hoc) Description: A custom Likert-type questionnaire (1-5) will evaluate the participant's perceived acceptability of the intervention, including clarity, comfort, and usability. Score Range: Minimum: 1 (least acceptable) Maximum: 5 (most acceptable) Interpretation: Higher scores indicate greater acceptability. | To the end of treatment at 12 weeks |
| Satisfaction with the intervention | Custom Likert-Scale Satisfaction Questionnaire (Ad Hoc) Description: A custom Likert-scale questionnaire will assess participant satisfaction with the intervention, including perceived usefulness and overall experience. Score Range: Minimum: 1 (least satisfied) Maximum: 5 (most satisfied) Interpretation: Higher scores indicate greater satisfaction | To the end of treatment at 12 weeks |
| Adverse events | Systematic adverse event log Description: Systematic recording of any adverse events occurring during the program, documented according to standard clinical criteria. Score Range: Not applicable (qualitative/quantitative event logging) Interpretation: Higher number or severity of adverse events indicates poorer safety. | To the end of treatment at 12 weeks |
| Back pain | Outcome measure: Brief Pain Inventory (BPI) Description: The Brief Pain Inventory assesses pain intensity (0-10) and pain interference with daily activities. Score Range: Intensity: 0 = no pain; 10 = worst imaginable Interference score: 0 = no interference; 10 = complete interference Interpretation: Higher scores indicate worse pain and greater functional impact. | From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period |
| Pelvic Floor distress | Pelvic Floor Distress Inventory (PFDI) Description: The Pelvic Floor Distress Inventory evaluates symptoms of pelvic floor dysfunction, including urinary, colorectal, and pelvic organ prolapse symptoms. Score Range: Minimum: 0 Maximum: 300 (depending on subscales used) Interpretation: Higher scores indicate greater symptom burden (worse outcome). | From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period |
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