Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:04 AM
Study NCT ID:
NCT07460492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plyometric Strength-Endurance Exercise in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life (Breast Cancer-Specific Quality of Life)', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period', 'description': 'EORTC QLQ-BR42: European Organisation for Research and Treatment of Cancer (EORTC) to assess breast cancer-specific quality of life.\n\nDescription:\n\nThe 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.\n\nScoring:\n\nItems 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.'}], 'secondaryOutcomes': [{'measure': 'Cardiorespiratory capacity', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period', 'description': '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.\n\nScore Range:\n\nMinimum 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.'}, {'measure': 'Cancer-related fatigue', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period', 'description': '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").\n\nScore Range:\n\nMinimum 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.'}, {'measure': 'Mobility and range of motion', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period', 'description': '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.\n\nScore Range:\n\nMinimum: 0 degrees (no active movement) Maximum: varies by joint Interpretation:Higher scores indicate better mobility and joint range of motion.'}, {'measure': 'Muscle strength', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period', 'description': '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.\n\nScore Range:\n\nMinimum: 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.\n\nInterpretation:\n\nHigher scores indicate a better outcome, reflecting greater muscular strength.'}, {'measure': 'Proprioception', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period', 'description': '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.\n\nScore Range: Joint position sense: error values typically expressed in degrees (°).\n\nMinimum 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\n\nInterpretation:\n\nLower error values indicate a better outcome (greater proprioceptive accuracy).'}, {'measure': 'Upper limb functionality', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period', 'description': '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.\n\nScore Range:\n\nMinimum: 0 (no disability → best outcome) Maximum: 100 (severe disability → worst outcome)\n\nInterpretation:\n\nHigher scores indicate a worse outcome (greater disability).\n\nOutcome Measure 2: Constant-Murley shoulder score\n\nDescription:\n\nThe 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.\n\nScore Range:\n\nMinimum: 0 (worst shoulder function) Maximum: 100 (normal shoulder function)\n\nInterpretation:\n\nHigher scores indicate a better outcome (greater shoulder function).'}, {'measure': 'Presence of lymphedema', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period', 'description': 'Outcome measure: Presence of lymphedema (Yes/No), symptom severity, and limb circumference measurements.\n\nDescription:\n\nLymphedema will be assessed through a combination of:\n\n* Presence/absence (Yes/No) of swelling;\n* Subjective symptoms (heaviness, tightness, pain) measured using a visual analog scale (0-10);\n* Circumference measurements (circumetry) at standardized anatomical points of the upper limb.\n\nScore Range:\n\nVisual analog scale: 0 (no symptoms) to 10 (worst symptoms). Circumference: no fixed minimum/maximum, values recorded in centimeters.\n\nInterpretation:\n\nHigher symptom scores and larger circumference values indicate worse lymphedema.'}, {'measure': 'Sleep quality', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period', 'description': '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.\n\nScore Range:\n\nMinimum: 0 Maximum: 21 Higher scores = worse sleep quality. Interpretation: A global score \\> 5 typically indicates poor sleep quality.'}, {'measure': 'Kinesiophobia', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period', 'description': '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).\n\nScore Range:\n\nMinimum: 11 Maximum: 44 Higher scores indicate greater fear of movement. Interpretation: Higher scores = worse outcome.'}, {'measure': 'Enjoyment of physical activity', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period', 'description': 'Measure 1: Enjoyment of physical activity (Physical Activity Enjoyment Scale - PACES-18)\n\nDescription:\n\n18-item validated scale assessing enjoyment of physical activity; items rated on a 7-point Likert scale.\n\nScore Range:\n\nMin: 18 (lowest enjoyment) Max: 126 (highest enjoyment)\n\nInterpretation:\n\nHigher scores = greater enjoyment of physical activity. Measure 2: Leisure-Time Physical Activity (Leisure-Time Physical Activity Questionnaire)\n\nDescription:\n\nSelf-reported weekly minutes of moderate and vigorous physical activity performed during leisure time.\n\nScore Range:\n\nMin: 0 minutes/week Max: No fixed upper limit\n\nInterpretation:\n\nHigher scores = greater leisure-time physical activity (better outcome).'}, {'measure': 'Exercise adherence rate', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period', 'description': 'Description: Adherence will be calculated using the formula:\n\n(Number of sessions completed / Number of scheduled sessions) × 100.\n\nScore Range:\n\nMinimum: 0% Maximum: 100%\n\nInterpretation:\n\nHigher percentages indicate better adherence.'}, {'measure': 'Intervention acceptability', 'timeFrame': 'To the end of treatment at 12 weeks', 'description': "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.\n\nScore Range:\n\nMinimum: 1 (least acceptable) Maximum: 5 (most acceptable) Interpretation: Higher scores indicate greater acceptability."}, {'measure': 'Satisfaction with the intervention', 'timeFrame': 'To the end of treatment at 12 weeks', 'description': '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.\n\nScore Range:\n\nMinimum: 1 (least satisfied) Maximum: 5 (most satisfied) Interpretation: Higher scores indicate greater satisfaction'}, {'measure': 'Adverse events', 'timeFrame': 'To the end of treatment at 12 weeks', 'description': 'Systematic adverse event log Description: Systematic recording of any adverse events occurring during the program, documented according to standard clinical criteria.\n\nScore Range: Not applicable (qualitative/quantitative event logging)\n\nInterpretation:\n\nHigher number or severity of adverse events indicates poorer safety.'}, {'measure': 'Back pain', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period', 'description': 'Outcome measure: Brief Pain Inventory (BPI) Description: The Brief Pain Inventory assesses pain intensity (0-10) and pain interference with daily activities.\n\nScore Range:\n\nIntensity: 0 = no pain; 10 = worst imaginable Interference score: 0 = no interference; 10 = complete interference Interpretation: Higher scores indicate worse pain and greater functional impact.'}, {'measure': 'Pelvic Floor distress', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period', 'description': '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.\n\nScore Range:\n\nMinimum: 0 Maximum: 300 (depending on subscales used) Interpretation: Higher scores indicate greater symptom burden (worse outcome).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Randomized Controlled Trial', 'Cluster Analysis', 'quality of life', 'physical functional performance', 'functional status', 'mental health'], 'conditions': ['Neoplams', 'Patients', 'Cancer Survivors']}, 'referencesModule': {'references': [{'pmid': '30658629', 'type': 'BACKGROUND', 'citation': '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': '33219115', 'type': 'BACKGROUND', 'citation': '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': '40005340', 'type': 'BACKGROUND', 'citation': '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': '22466394', 'type': 'BACKGROUND', 'citation': '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': '39985582', 'type': 'BACKGROUND', 'citation': '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': '34753640', 'type': 'BACKGROUND', 'citation': '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': '27736266', 'type': 'BACKGROUND', 'citation': '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': '36512157', 'type': 'BACKGROUND', 'citation': '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': '39282024', 'type': 'BACKGROUND', 'citation': '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': '33407753', 'type': 'BACKGROUND', 'citation': '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': '32415386', 'type': 'BACKGROUND', 'citation': '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': '20556760', 'type': 'BACKGROUND', 'citation': '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': '37922449', 'type': 'BACKGROUND', 'citation': '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': '27632848', 'type': 'BACKGROUND', 'citation': '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': '39195593', 'type': 'BACKGROUND', 'citation': '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': '37833510', 'type': 'BACKGROUND', 'citation': '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': '8343780', 'type': 'BACKGROUND', 'citation': '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': '29174999', 'type': 'BACKGROUND', 'citation': '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': '26894494', 'type': 'BACKGROUND', 'citation': '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': '16500198', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nUsing 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.', 'detailedDescription': '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.\n\nMost 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.\n\nPlyometric 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18 years or older.\n* Prior diagnosis of breast cancer.\n* History of mastectomy, including unilateral procedures, total breast surgery, or breast-conserving surgery.\n* Completion of postoperative chemotherapy or radiotherapy, when indicated.\n* Absence of contraindications for physiotherapy or therapeutic exercise.\n* Willingness to voluntarily participate in the study.\n* Ability to understand and sign the informed consent form.\n* Availability to participate in the training program for the entire intervention period (approximately 12 weeks).\n\nExclusion Criteria\n\n* Participants will be excluded if any of the following conditions are present:\n* 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.\n* Current diagnosis of cardiovascular, respiratory, neuromuscular, or musculoskeletal diseases that contraindicate physical exercise or impair safe completion of the program.\n* Major surgery within the previous 6 months without medical clearance to resume physical activity.\n* Cognitive impairment or mental health conditions that limit comprehension of instructions or safe engagement in the intervention.\n* Current pregnancy.\n* 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).'}, 'identificationModule': {'nctId': 'NCT07460492', 'briefTitle': 'Plyometric Strength-Endurance Exercise in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Vigo'}, 'officialTitle': 'Therapeutic Plyometric-Based Strength-Endurance Exercise Program for Breast Cancer Patients and Survivors to Improve Quality of Life and Physical and Mental Function', 'orgStudyIdInfo': {'id': '2025/263'}, 'secondaryIdInfos': [{'id': '2025/001', 'type': 'OTHER', 'domain': 'COFIGA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Plyometric Strength-Endurance Training Program', 'description': "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.\n\nA 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.", 'interventionNames': ['Other: Plyometric Strength-Endurance Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Strength Training', 'description': '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.', 'interventionNames': ['Other: Conventional Strength Training']}], 'interventions': [{'name': 'Plyometric Strength-Endurance Training', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Plyometric Strength-Endurance Training Program']}, {'name': 'Conventional Strength Training', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Conventional Strength Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36001', 'city': 'Pontevedra', 'state': 'Galicia', 'country': 'Spain', 'contacts': [{'name': 'Yoana Gonzalez Gonzalez, PhD', 'role': 'CONTACT', 'email': 'yoana@uvigo.gal', 'phone': '+34) 986801767'}], 'facility': 'Faculty of Physiotherapy', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}], 'centralContacts': [{'name': 'Yoana Gonzalez-Gonzalez, PhD', 'role': 'CONTACT', 'email': 'yoana@uvigo.gal', 'phone': '(+34) 986 801767'}, {'name': 'Gloria María Cascallar Cascallar, Graduate', 'role': 'CONTACT', 'email': 'gloria.maria.cascallar.cascallar@sergas.es'}], 'overallOfficials': [{'name': 'Yoana Gonzalez Gonzalez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University ofVigo'}, {'name': 'Gloria M Cascallar Cascallar, Graduate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SERGAS (Servicio galego de Saúde), Galician Health Service, Spanish Social Security System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The individual participant data (IPD) from this study will not be shared.\n\nData 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:\n\nThe dataset contains sensitive personal and health information from oncology patients, and sharing it could compromise participant privacy.\n\nParticipants did not consent to external sharing of their individual data beyond the research team.\n\nThe study protocol prioritizes strict confidentiality in accordance with European data protection regulations (GDPR) and institutional policies.\n\nThe size and nature of the dataset increase the risk of re-identification, even after de-identification procedures.\n\nFor these reasons, no individual-level data will be made publicly available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vigo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical researcher, PhD', 'investigatorFullName': 'Yoana González González', 'investigatorAffiliation': 'University of Vigo'}}}}