NCT07460492

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

March 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2026

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 3, 2026

Last Update Submit

March 10, 2026

Conditions

Keywords

Randomized Controlled TrialCluster Analysisquality of lifephysical functional performancefunctional statusmental health

Outcome Measures

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.

    From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period

Secondary Outcomes (16)

  • Cardiorespiratory capacity

    From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period

  • Cancer-related fatigue

    From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period

  • Mobility and range of motion

    From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period

  • Muscle strength

    From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period

  • Proprioception

    From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period

  • +11 more secondary outcomes

Study Arms (2)

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.

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.

Other: Conventional Strength Training

Interventions

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.

Plyometric Strength-Endurance Training Program

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.

Conventional Strength Training

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physiotherapy

Pontevedra, Galicia, 36001, Spain

Location

Related Publications (20)

  • 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.

    PMID: 30658629BACKGROUND
  • Breda 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.

    PMID: 33219115BACKGROUND
  • Abd 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.

    PMID: 40005340BACKGROUND
  • Johnson 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.

    PMID: 22466394BACKGROUND
  • Elnaggar 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.

    PMID: 39985582BACKGROUND
  • Elnaggar 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.

    PMID: 34753640BACKGROUND
  • Ulrich 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.

    PMID: 27736266BACKGROUND
  • Lin 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.

    PMID: 36512157BACKGROUND
  • Xu 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.

    PMID: 39282024BACKGROUND
  • Shao 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.

    PMID: 33407753BACKGROUND
  • Hasenoehrl 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.

    PMID: 32415386BACKGROUND
  • McNeely 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.

    PMID: 20556760BACKGROUND
  • Abd-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.

    PMID: 37922449BACKGROUND
  • Swanik 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.

    PMID: 27632848BACKGROUND
  • Dhote 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.

    PMID: 39195593BACKGROUND
  • Garcia-Carrillo E, Ramirez-Campillo R, Thapa RK, Afonso J, Granacher U, Izquierdo M. Effects of Upper-Body Plyometric Training on Physical Fitness in Healthy Youth and Young Adult Participants: A Systematic Review with Meta-Analysis. Sports Med Open. 2023 Oct 13;9(1):93. doi: 10.1186/s40798-023-00631-2.

    PMID: 37833510BACKGROUND
  • Wilk KE, Voight ML, Keirns MA, Gambetta V, Andrews JR, Dillman CJ. Stretch-shortening drills for the upper extremities: theory and clinical application. J Orthop Sports Phys Ther. 1993 May;17(5):225-39. doi: 10.2519/jospt.1993.17.5.225.

    PMID: 8343780BACKGROUND
  • Singla D, Hussain ME, Moiz JA. Effect of upper body plyometric training on physical performance in healthy individuals: A systematic review. Phys Ther Sport. 2018 Jan;29:51-60. doi: 10.1016/j.ptsp.2017.11.005. Epub 2017 Nov 11.

    PMID: 29174999BACKGROUND
  • Maenhout A, Benzoor M, Werin M, Cools A. Scapular muscle activity in a variety of plyometric exercises. J Electromyogr Kinesiol. 2016 Apr;27:39-45. doi: 10.1016/j.jelekin.2016.01.003. Epub 2016 Jan 28.

    PMID: 26894494BACKGROUND
  • Stubblefield MD, Custodio CM. Upper-extremity pain disorders in breast cancer. Arch Phys Med Rehabil. 2006 Mar;87(3 Suppl 1):S96-9; quiz S100-1. doi: 10.1016/j.apmr.2005.12.017.

    PMID: 16500198BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • 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

Central Study Contacts

Yoana Gonzalez-Gonzalez, PhD

CONTACT

Gloria María Cascallar Cascallar, Graduate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical researcher, PhD

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 10, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

July 20, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations