Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-02-28 @ 3:48 AM
Study NCT ID:
NCT06771635
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2025-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Physical Training Program on the Exercise Adherence for Breast Cancer Survivor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Is a prospective, multicenter, randomized, parallel-controlled, prospective pilot study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-01-07', 'studyFirstSubmitQcDate': '2025-01-10', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Quality of Life (FACT-B total score)', 'timeFrame': 'Baseline, post-intervention (6 weeks), 3 months, and 6 months.', 'description': 'Quality of life measured with the validated Spanish version of the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. Includes five subscales: physical, social/family, emotional, functional well-being, and breast cancer concerns. Higher scores indicate better quality of life.'}], 'secondaryOutcomes': [{'measure': 'Change in Emotional Well-Being (FACT-B subscale)', 'timeFrame': 'Baseline, post-intervention (6 weeks), 3 months, and 6 months.', 'description': 'Emotional well-being assessed with the FACT-B questionnaire. Higher scores indicate better emotional status.'}, {'measure': 'Change in Physical Activity Level (MET-min/week, GPAQ)', 'timeFrame': 'Baseline, post-intervention (6 weeks), 3 months, and 6 months.', 'description': 'Physical activity levels assessed using the Global Physical Activity Questionnaire (GPAQ). Data expressed in MET-minutes per week across work, transport, and leisure domains.'}, {'measure': 'Mean Sedentary Time (minutes/day, GPAQ)', 'timeFrame': 'Baseline, post-intervention (6 weeks), 3 months, and 6 months.', 'description': 'Sedentary behavior measured using the GPAQ. Time spent sitting or reclining per day is recorded in minutes.'}, {'measure': 'Adherence to Exercise Program (% sessions attended)', 'timeFrame': 'During the 6-week intervention period.', 'description': 'Exercise adherence calculated as percentage of supervised sessions attended out of the 12 prescribed sessions.'}, {'measure': 'Change in Weight (kg)', 'timeFrame': 'Baseline, post-intervention (6 weeks), 3 months, and 6 months', 'description': 'Body weight measured with a calibrated SECA® scale.'}, {'measure': 'Change in Height (cm)', 'timeFrame': 'Baseline, post-intervention (6 weeks), 3 months, and 6 months.', 'description': 'Height measured with a stadiometer.'}, {'measure': 'Change in Body Mass Index (kg/m²)', 'timeFrame': 'Baseline, post-intervention (6 weeks), 3 months, and 6 months.', 'description': 'Body mass index calculated as weight (kg)/height (m²).'}, {'measure': 'Change in Handgrip Strength (kg, dynamometer)', 'timeFrame': 'Baseline, post-intervention (6 weeks), 3 months, and 6 months.', 'description': 'Handgrip strength measured using a handheld dynamometer, following standardized ACSM protocols.'}, {'measure': 'Change in Harvard Step Test Score (index units)', 'timeFrame': 'Baseline, post-intervention (6 weeks), 3 months, and 6 months.', 'description': 'Cardiorespiratory fitness assessed with the Harvard Step Test. The fitness index score is calculated as \\[exercise duration in seconds × 100\\] / \\[2 × (sum of heartbeats in recovery periods)\\].'}, {'measure': 'Patient Satisfaction Score (Likert 0-5 scale)', 'timeFrame': 'Immediately post-intervention (6 weeks).', 'description': 'Satisfaction with the program assessed using a study-specific survey (0-5 Likert scale) evaluating perceived usefulness, expectations, and adherence intention. Higher scores indicate greater satisfaction.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Physical activity', 'Adherence', 'Concurrent training'], 'conditions': ['Breast Cancer Stage I', 'Breast Cancer Stage II', 'Breast Cancer Stage III', 'Breast Cancer Stage IIIA']}, 'referencesModule': {'references': [{'pmid': '34989765', 'type': 'BACKGROUND', 'citation': 'Cao C, Friedenreich CM, Yang L. Association of Daily Sitting Time and Leisure-Time Physical Activity With Survival Among US Cancer Survivors. JAMA Oncol. 2022 Mar 1;8(3):395-403. doi: 10.1001/jamaoncol.2021.6590.'}, {'pmid': '31144265', 'type': 'BACKGROUND', 'citation': 'Weiner LS, Takemoto M, Godbole S, Nelson SH, Natarajan L, Sears DD, Hartman SJ. Breast cancer survivors reduce accelerometer-measured sedentary time in an exercise intervention. J Cancer Surviv. 2019 Jun;13(3):468-476. doi: 10.1007/s11764-019-00768-8. Epub 2019 May 29.'}, {'pmid': '18487249', 'type': 'BACKGROUND', 'citation': 'Friedenreich CM, Cust AE. Physical activity and breast cancer risk: impact of timing, type and dose of activity and population subgroup effects. Br J Sports Med. 2008 Aug;42(8):636-47. doi: 10.1136/bjsm.2006.029132. Epub 2008 May 16.'}]}, 'descriptionModule': {'briefSummary': 'Breast cancer (BC) is one of the most common cancers among women worldwide, with survival rates steadily improving due to advances in early detection and treatment. Despite these improvements, survivors frequently experience long-term side effects such as fatigue, reduced physical function, osteosarcopenia (loss of muscle mass and bone density), and diminished quality of life (QOL). These sequelae often lead to loss of independence, increased frailty, and reduced participation in daily activities.\n\nPhysical activity, particularly structured and supervised programs, has been shown to mitigate many of these effects. Concurrent training, which combines strength, cardiovascular, and neuromotor exercise, provides a comprehensive approach that targets muscle mass, bone health, and functional mobility. However, adherence to regular physical activity in this population remains low, with most survivors not achieving recommended levels of at least 150 minutes per week of moderate-to-vigorous exercise.\n\nThis pilot randomized controlled trial aims to evaluate the effects of a 6-week supervised concurrent training program in breast cancer survivors. The program includes 12 supervised sessions designed to improve exercise adherence, physical activity levels, and QOL. The intervention is compared with a control group that receives only a health education session. Outcomes include QOL assessed by the FACT-B questionnaire, physical activity levels measured by the GPAQ, sedentary time, functional fitness, anthropometry, and patient satisfaction.\n\nThe study is expected to provide evidence that a short-term supervised concurrent training program can improve emotional well-being, preserve QOL, and increase adherence to physical activity in breast cancer survivors.', 'detailedDescription': 'Study design and participants\n\nThis is a prospective, multicenter, randomized, parallel-controlled pilot study conducted in two Spanish tertiary hospitals. Breast cancer survivors aged 18-65 years, with stage I-IIIA disease, free of active disease, and not undergoing active chemotherapy were eligible. Participants were required to be sedentary or physically inactive according to World Health Organization guidelines. Exclusion criteria included serious comorbidities preventing exercise, postoperative complications, lymphedema grade \\>2, or current practice of \\>150 minutes of moderate-to-vigorous physical activity per week.\n\nSeventy-eight women were screened, of whom 62 were randomized (intervention group: n=32; control group: n=30). At the 3-month follow-up, 37 participants completed the assessments (intervention: n=15; control: n=22).\n\nIntervention\n\nThe intervention consisted of three stages:\n\nAssessment stage\n\nInitial medical and nursing evaluation: clinical history, inclusion/exclusion criteria, anthropometric measurements (weight, height, BMI), and baseline physical activity levels using the Global Physical Activity Questionnaire (GPAQ).\n\nBaseline functional evaluation: handgrip strength with dynamometer, Harvard Step Test, and baseline QOL with the FACT-B questionnaire.\n\nExecution stage\n\nBoth groups attended a formative session on healthy lifestyle and nutrition.\n\nThe intervention group then completed 12 supervised concurrent training sessions (two 1-hour sessions per week for 6 weeks). Training components included:\n\nResistance training: circuit format, 8-12 repetitions at 60-80% estimated 1RM, with progressive overload based on baseline strength testing.\n\nCardiovascular training: treadmill, bicycle, or elliptical at 60-75% estimated maximum heart rate (HRmax = 208.75 - 0.73 × age), lasting 25-50 minutes per session.\n\nNeuromotor training: choreographies with music and stretching, performed at \\<60% HRmax.\n\nParticipants wore heart rate monitors during all sessions to ensure training safety and adherence to intensity guidelines.\n\nFollow-up stage\n\nEvaluations were performed at 1, 3, and 6 months after the intervention. Questionnaires were completed by mail, telephone, or in-person visits.\n\nControl group\n\nThe control group attended only the health education session on lifestyle and nutrition and did not participate in the exercise program. Participants continued to receive standard medical care.\n\nOutcomes\n\nPrimary outcome: Quality of life, measured with the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire at baseline, post-intervention (6 weeks), and at 3- and 6-month follow-up.\n\nSecondary outcomes:\n\nEmotional well-being subscale of FACT-B.\n\nPhysical activity levels (MET-minutes/week) using the GPAQ.\n\nSedentary behavior (minutes/day sitting).\n\nAdherence to exercise program (% of sessions attended).\n\nAnthropometric outcomes: BMI, weight, height.\n\nFunctional fitness: handgrip strength and Harvard Step Test performance.\n\nPatient satisfaction with the program (Likert survey).\n\nStatistical analysis\n\nContinuous variables are expressed as mean ± standard deviation (SD). Categorical variables are expressed as number and percentage. Statistical analyses were performed with SPSS v28 (IBM Inc., Chicago, IL, USA). A p-value \\<0.05 was considered statistically significant.\n\nNormality was assessed using the Kolmogorov-Smirnov test and homoscedasticity with the Levene test. Group comparisons were performed with univariate tests. Repeated-measures ANOVA was used to analyze time × group effects on adherence and QOL outcomes. Effect sizes were calculated using partial eta squared (η²p) and interpreted as: no effect (0-0.05), minimal (0.05-0.26), moderate (0.26-0.64), or strong (≥0.64).\n\nEthical considerations\n\nThe study was conducted in accordance with the Declaration of Helsinki and approved by the appropriate ethics committees. Written informed consent was obtained from all participants before study enrollment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage I-IIIA\n* Free of disease\n* Without active chemotherapeutic treatment\n\nExclusion Criteria:\n\n* Patients suffered from a chronic disease that prevented them from physical activity program\n* Patients with sequelae of surgery, edema of \\>2 degrees in extremities with lymphadenectomy\n* Those women who performed PA according to the recommendations established by the WHO.'}, 'identificationModule': {'nctId': 'NCT06771635', 'briefTitle': 'Effect of Physical Training Program on the Exercise Adherence for Breast Cancer Survivor', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Burgos'}, 'officialTitle': 'Effects of a Targeted Concurrent Training Program on the Exercise Adherence in Female Breast Cancer Survivors: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2018/0009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Concurrent Training Program', 'description': 'This group will participate in a 6-week concurrent training program.', 'interventionNames': ['Other: concurrent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Education Only (Control)', 'description': 'This group will no participate in the concurrent training intervention program.', 'interventionNames': ['Behavioral: Health Education Session']}], 'interventions': [{'name': 'concurrent', 'type': 'OTHER', 'description': 'The concurrent training program is divided into three types of training: endurance, cardiovascular and neuromotor.\n\nResistance training sessions were performed in a circuit format with \\>30" rest periods between exercises. The volume of work ranged from 8 to 12 repetitions at 60% of the estimated 1 maximum repetition (RM).\n\nThe cardiovascular work time per session ranged from 25-50 min depending on the intensity of the exercise and the intensity was regulated according to the maximum heart rate (FHR) estimated for each subject between 60-75%\n\nThe neuromotor training intensity of the sessions was low. The participants wore a heart rate monitor and were instructed not to exceed 60% of their HRF', 'armGroupLabels': ['Concurrent Training Program']}, {'name': 'Health Education Session', 'type': 'BEHAVIORAL', 'description': 'Single formative session on healthy lifestyle and nutrition provided to both groups. Control group received only this session without concurrent training.', 'armGroupLabels': ['Health Education Only (Control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09001', 'city': 'Burgos', 'state': 'Burgos', 'country': 'Spain', 'facility': 'Universidad de Burgos', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}], 'overallOfficials': [{'name': 'Juan Mielgo-Ayuso, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de Burgos'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only IPD used in the results publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Burgos', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundación Instituto Valenciano de Oncología', 'class': 'OTHER'}, {'name': 'Fundación Trinidad Alfonso', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}