NeoplamsNCT07460492
Plyometric Strength-Endurance Exercise in Breast Cancer
A study testing Plyometric Strength-Endurance Training and Conventional Strength Training in people with Neoplams and Patients, run by University of Vigo at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neoplams, Patients, Cancer Survivors
- What is being tested?
- Plyometric Strength-Endurance Training and Conventional Strength Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSpain
- Study dates
- 20 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Absence of contraindications for physiotherapy or therapeutic exercise.
- Willingness to voluntarily participate in the study.
- Ability to understand and sign the informed consent form.
- Availability to participate in the training program for the entire intervention period (approximately 12 weeks).
Who cannot join
- Participants will be excluded if any of the following conditions are present:
- 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.
- Current pregnancy.
- Lack of medical clearance for moderate-to-vigorous physical activity (as indicated by a medical certificate specifying the duration of the restriction and the conditions under which exercise may be resumed).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gloria María Cascallar Cascallar, Graduate contact
Spain1 site
Faculty of Physiotherapy
Pontevedra, Galicia, 36001
Yoana Gonzalez Gonzalez, PhD, +34) 986801767, yoana@uvigo.gal
About this study
Official title: Therapeutic Plyometric-Based Strength-Endurance Exercise Program for Breast Cancer Patients and Survivors to Improve Quality of Life and Physical and Mental Function
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.
Read the detailed description
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.
- Conditions
- Neoplams, Patients, Cancer Survivors
- Being tested
- Plyometric Strength-Endurance Training, Conventional Strength Training
- Keywords
- Randomized Controlled Trial, Cluster Analysis, quality of life, physical functional performance, functional status, mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plyometric Strength-Endurance TrainingOther
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.
Conventional Strength TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Plyometric Strength-Endurance Training |
| 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. Receives: Other: Conventional Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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:
- Presence/absence (Yes/No) of swelling;
- Subjective symptoms (heaviness, tightness, pain) measured using a visual analog scale (0-10);
- Circumference measurements (circumetry) at standardized anatomical points of the upper limb.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start20 Apr 2026 (estimated)
- Primary completion20 Jul 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for NeoplamsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoana González González, University of Vigo
- Investigators
- Yoana Gonzalez Gonzalez, PhD, Principal investigator, University ofVigoGloria M Cascallar Cascallar, Graduate, Principal investigator, SERGAS (Servicio galego de Saúde), Galician Health Service, Spanish Social Security System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460492
- Sponsor's protocol ID
- 2025/263
- Other IDs
- 2025/001
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 30658629Breda SJ, Oei EHG, Zwerver J, Visser E, Waarsing E, Krestin GP, de Vos RJ. Effectiveness of progressive tendon-loading exercise therapy in patients with patellar tendinopathy: a randomised clinical trial. Br J Sports Med. 2021 May;55(9):501-509. doi: 10.1136/bjsports-2020-103403. Epub 2020 Nov 20.
PubMed 33219115Abd Elsabour AK, Zakaria HM, Fahmy EM, Khalil ASA, Alwhaibi RM, Ragab WM, Taha SI. Effect of Plyometric Exercises of Lower Limb on Strength, Postural Control, and Risk of Falling in Stroke Patients. Medicina (Kaunas). 2025 Jan 26;61(2):223. doi: 10.3390/medicina61020223.
PubMed 40005340Johnson BA, Salzberg CL, Stevenson DA. Effects of a plyometric training program for 3 children with neurofibromatosis type 1. Pediatr Phys Ther. 2012 Summer;24(2):199-208. doi: 10.1097/PEP.0b013e31824d30ee.
PubMed 22466394Elnaggar RK, Mahmoud WS, Abdrabo MS, Elfakharany MS. Effect of adaptive variable-resistance training on chemotherapy-induced sarcopenia, fatigue, and functional restriction in pediatric survivors of acute lymphoblastic leukemia: a prospective randomized controlled trial. Support Care Cancer. 2025 Feb 22;33(3):214. doi: 10.1007/s00520-025-09250-x.
PubMed 39985582Elnaggar RK, Mohamed RR. Aqua-Plyometric Exercises: Potential Implications for Bone Mineral Density, Functional Capacity, and Quality of Life in Survivors of Childhood Acute Lymphoblastic Leukemia. Semin Oncol Nurs. 2021 Dec;37(6):151225. doi: 10.1016/j.soncn.2021.151225. Epub 2021 Nov 6.
PubMed 34753640Ulrich G, Parstorfer M. Effects of Plyometric Versus Concentric and Eccentric Conditioning Contractions on Upper-Body Postactivation Potentiation. Int J Sports Physiol Perform. 2017 Jul;12(6):736-741. doi: 10.1123/ijspp.2016-0278. Epub 2016 Oct 13.
PubMed 27736266Lin Y, Wu C, He C, Yan J, Chen Y, Gao L, Liu R, Cao B. Effectiveness of three exercise programs and intensive follow-up in improving quality of life, pain, and lymphedema among breast cancer survivors: a randomized, controlled 6-month trial. Support Care Cancer. 2022 Dec 13;31(1):9. doi: 10.1007/s00520-022-07494-5.
PubMed 36512157Xu Q, Liu C, Jia S, Wang P, Liu Q, Ding F, Ren Y, Ma X, Zhu J. Effect of physical exercise on postoperative shoulder mobility and upper limb function in patients with breast cancer: a systematic review and meta-analysis. Gland Surg. 2024 Aug 31;13(8):1494-1510. doi: 10.21037/gs-24-255. Epub 2024 Aug 22.
PubMed 39282024Shao YW, Shu Q, Xu D, Teng H, Wu GS, Hou JX, Tian J. Effect of different rehabilitation training timelines to prevent shoulder dysfunction among postoperative breast cancer patients: study protocol for a randomized controlled trial. Trials. 2021 Jan 6;22(1):16. doi: 10.1186/s13063-020-04954-3.
PubMed 33407753Hasenoehrl T, Palma S, Ramazanova D, Kolbl H, Dorner TE, Keilani M, Crevenna R. Resistance exercise and breast cancer-related lymphedema-a systematic review update and meta-analysis. Support Care Cancer. 2020 Aug;28(8):3593-3603. doi: 10.1007/s00520-020-05521-x. Epub 2020 May 15.
PubMed 32415386McNeely ML, Campbell K, Ospina M, Rowe BH, Dabbs K, Klassen TP, Mackey J, Courneya K. Exercise interventions for upper-limb dysfunction due to breast cancer treatment. Cochrane Database Syst Rev. 2010 Jun 16;2010(6):CD005211. doi: 10.1002/14651858.CD005211.pub2.
PubMed 20556760Abd-Elmonem AM, Ali HA, Saad-Eldien SS, El-Nabie WAA. Efficacy of plyometric exercises on upper extremity function, selective motor control and hand grip strength in children with unilateral cerebral palsy: A randomized controlled study. Physiother Res Int. 2024 Jan;29(1):e2061. doi: 10.1002/pri.2061. Epub 2023 Nov 3.
PubMed 37922449Swanik KA, Thomas SJ, Struminger AH, Bliven KC, Kelly JD, Swanik CB. The Effect of Shoulder Plyometric Training on Amortization Time and Upper-Extremity Kinematics. J Sport Rehabil. 2016 Dec;25(4):315-323. doi: 10.1123/jsr.2015-0005. Epub 2016 Aug 24.
PubMed 27632848Dhote S, Eon P, Grospretre S. A Comparison of the Plyometric Performance of Upper Limbs between Experienced and Non-Experienced Athletes. Sports (Basel). 2024 Aug 12;12(8):217. doi: 10.3390/sports12080217.
PubMed 39195593
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Plyometric-Based Strength-Endurance Exercise Program for Breast Cancer Patients and Survivors to Improve Quality of Life and Physical and Mental Function
- ClinicalTrials.gov ID
- NCT07460492
- Acronym / sponsor ID
- 2025/263
- Conditions
- Neoplams, Patients, Cancer Survivors
- Keywords
- Randomized Controlled Trial, Cluster Analysis, quality of life, physical functional performance, functional status, mental health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plyometric Strength-Endurance Training Program | Experimental | Other: Plyometric Strength-Endurance TrainingParticipants 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. |
| Conventional Strength Training | Active comparator | Other: Conventional Strength TrainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Absence of contraindications for physiotherapy or therapeutic exercise.
Key exclusion criteria (7 listed)
- Participants will be excluded if any of the following conditions are present:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plyometric Strength-Endurance TrainingParticipants 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. | Other | Plyometric Strength-Endurance Training Program |
| Conventional Strength TrainingParticipants 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. | Other | Conventional Strength Training |
Primary outcome
Quality of life (Breast Cancer-Specific Quality of Life)
Time frame: From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period
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.
16 secondary outcomes
Cardiorespiratory capacity
Time frame: From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period
Cancer-related fatigue
Time frame: From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period
Mobility and range of motion
Time frame: From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period
Muscle strength
Time frame: From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period
Proprioception
Time frame: From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period
Upper limb functionality
Time frame: From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period
Presence of lymphedema
Time frame: From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period
Sleep quality
Time frame: From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period
Kinesiophobia
Time frame: From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period
Enjoyment of physical activity
Time frame: From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period
Exercise adherence rate
Time frame: From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period
Intervention acceptability
Time frame: To the end of treatment at 12 weeks
Satisfaction with the intervention
Time frame: To the end of treatment at 12 weeks
Adverse events
Time frame: To the end of treatment at 12 weeks
Back pain
Time frame: From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period
Pelvic Floor distress
Time frame: From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Background: PubMed 30658629Paulo 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.
- Background: PubMed 33219115Breda SJ, Oei EHG, Zwerver J, Visser E, Waarsing E, Krestin GP, de Vos RJ. Effectiveness of progressive tendon-loading exercise therapy in patients with patellar tendinopathy: a randomised clinical trial. Br J Sports Med. 2021 May;55(9):501-509. doi: 10.1136/bjsports-2020-103403. Epub 2020 Nov 20.
- Background: PubMed 40005340Abd Elsabour AK, Zakaria HM, Fahmy EM, Khalil ASA, Alwhaibi RM, Ragab WM, Taha SI. Effect of Plyometric Exercises of Lower Limb on Strength, Postural Control, and Risk of Falling in Stroke Patients. Medicina (Kaunas). 2025 Jan 26;61(2):223. doi: 10.3390/medicina61020223.
- Background: PubMed 22466394Johnson BA, Salzberg CL, Stevenson DA. Effects of a plyometric training program for 3 children with neurofibromatosis type 1. Pediatr Phys Ther. 2012 Summer;24(2):199-208. doi: 10.1097/PEP.0b013e31824d30ee.
- Background: PubMed 39985582Elnaggar RK, Mahmoud WS, Abdrabo MS, Elfakharany MS. Effect of adaptive variable-resistance training on chemotherapy-induced sarcopenia, fatigue, and functional restriction in pediatric survivors of acute lymphoblastic leukemia: a prospective randomized controlled trial. Support Care Cancer. 2025 Feb 22;33(3):214. doi: 10.1007/s00520-025-09250-x.
- Background: PubMed 34753640Elnaggar RK, Mohamed RR. Aqua-Plyometric Exercises: Potential Implications for Bone Mineral Density, Functional Capacity, and Quality of Life in Survivors of Childhood Acute Lymphoblastic Leukemia. Semin Oncol Nurs. 2021 Dec;37(6):151225. doi: 10.1016/j.soncn.2021.151225. Epub 2021 Nov 6.
- Background: PubMed 27736266Ulrich G, Parstorfer M. Effects of Plyometric Versus Concentric and Eccentric Conditioning Contractions on Upper-Body Postactivation Potentiation. Int J Sports Physiol Perform. 2017 Jul;12(6):736-741. doi: 10.1123/ijspp.2016-0278. Epub 2016 Oct 13.
- Background: PubMed 36512157Lin Y, Wu C, He C, Yan J, Chen Y, Gao L, Liu R, Cao B. Effectiveness of three exercise programs and intensive follow-up in improving quality of life, pain, and lymphedema among breast cancer survivors: a randomized, controlled 6-month trial. Support Care Cancer. 2022 Dec 13;31(1):9. doi: 10.1007/s00520-022-07494-5.
- Background: PubMed 39282024Xu Q, Liu C, Jia S, Wang P, Liu Q, Ding F, Ren Y, Ma X, Zhu J. Effect of physical exercise on postoperative shoulder mobility and upper limb function in patients with breast cancer: a systematic review and meta-analysis. Gland Surg. 2024 Aug 31;13(8):1494-1510. doi: 10.21037/gs-24-255. Epub 2024 Aug 22.
- Background: PubMed 33407753Shao YW, Shu Q, Xu D, Teng H, Wu GS, Hou JX, Tian J. Effect of different rehabilitation training timelines to prevent shoulder dysfunction among postoperative breast cancer patients: study protocol for a randomized controlled trial. Trials. 2021 Jan 6;22(1):16. doi: 10.1186/s13063-020-04954-3.
- Background: PubMed 32415386Hasenoehrl T, Palma S, Ramazanova D, Kolbl H, Dorner TE, Keilani M, Crevenna R. Resistance exercise and breast cancer-related lymphedema-a systematic review update and meta-analysis. Support Care Cancer. 2020 Aug;28(8):3593-3603. doi: 10.1007/s00520-020-05521-x. Epub 2020 May 15.
- Background: PubMed 20556760McNeely ML, Campbell K, Ospina M, Rowe BH, Dabbs K, Klassen TP, Mackey J, Courneya K. Exercise interventions for upper-limb dysfunction due to breast cancer treatment. Cochrane Database Syst Rev. 2010 Jun 16;2010(6):CD005211. doi: 10.1002/14651858.CD005211.pub2.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gloria María Cascallar Cascallar, Graduate contact
Yoana Gonzalez Gonzalez, PhD principal investigator
University ofVigo
Gloria M Cascallar Cascallar, Graduate principal investigator
SERGAS (Servicio galego de Saúde), Galician Health Service, Spanish Social Security System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plyometric Strength-Endurance Training and Conventional Strength Training in people with Neoplams and Patients, run by University of Vigo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yoana Gonzalez-Gonzalez, PhD ((+34) 986 801767, yoana@uvigo.gal), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (Breast Cancer-Specific Quality of Life) (time frame: From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07460492, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.