Clinical trial · Interventional
Remotely Supervised Exercise During Chemotherapy in Women With Breast Cancer
Effect of Remotely Supervised Combined Aerobic and Resistance Exercise Training on Physical Health and Quality of Life in Women With Breast Cancer During Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The RE-CARE project is designed to evaluate the effects of a 24-week, remotely supervised, combined high-intensity interval aerobic and resistance exercise training on physical health and quality of life in patients with breast cancer (BC) undergoing neoadjuvant chemotherapy (NACT). The study will enroll women aged 30-65 years with previously untreated, primary breast cancer, clinical stage IIA-IIB or IIIA-IIIC, who are scheduled to receive doxorubicin/cyclophosphamide-based NACT. Participants will be randomly allocated to either an experimental intervention group or a control group. At baseline, comprehensive assessments will be conducted to evaluate cardiorespiratory fitness, physical endurance, muscle strength, cognitive function, and health-related quality of life. The primary objective is to determine the impact of the remotely supervised combined aerobic and resistance exercise on incidence and severity of NACT-related adverse effects in patients with BC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intervention Group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group
- description
- The control group will maintain their routine activities and usual care and will receive the American College of Sports Medicine (ACSM) guidelines (Campbell et al., 2019), but they will not be assigned any structured physical exercise program during the study period.
- type
- EXPERIMENTAL
- label
- Intervention group
- interventionNames
- Other: Intervention Group
Primary outcomes (3)
- measure
- Change in cardiorespiratory functioning, assessed by incremental test according to the University of Northern Colorado Cancer Rehabilitation Institute (UNCCRI) Treadmill protocol
- timeFrame
- From baseline to 6 months after the intervention
- description
- The UNCCRI Treadmill Protocol includes twenty-one 1-minute stages, with systematic increments in treadmill speed and/or grade at each stage. Outcome measures will include maximal oxygen uptake (max ml/kg/min) and ventilatory variables such as minute ventilation (L/min) and respiratory exchange ratio (RER). Heart rate (beats/min) will be continuously monitored throughout each test using a heart rate monitor. Time to exhaustion, treadmill speed, and treadmill grade will be recorded at the point of test termination. Data obtained will be analyzed using repeated-measures analysis and linear mixed-effects models.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * previously untreated primary breast cancer; * stage IIA-B, IIIA-C at diagnosis; * diagnosis established by core needle biopsy; * age 30-65 years; * prescribed doxorubicin/cyclophosphamide-based NACT. Exclusion Criteria: * cardiac pathologies (assessed by echocardiogram); * blood transfusion in the last six months; * another oncological disease; * previous chemotherapy, hormonal or X-ray treatment; * participation in another clinical trial.
References
Publications (8)
- BACKGROUNDKlavina A, Ceseiko R, Campa M, Jermolenko GF, Eglitis K, Llorente A, Line A. The Effect of High-Intensity Interval Training on Quality of Life and Incidence of Chemotherapy Side Effects in Women With Breast Cancer. Integr Cancer Ther. 2024 Jan-Dec;23:15347354241297385. doi: 10.1177/15347354241297385. PMID 39548802
- BACKGROUNDKopp B, Lange F, Steinke A. The Reliability of the Wisconsin Card Sorting Test in Clinical Practice. Assessment. 2021 Jan;28(1):248-263. doi: 10.1177/1073191119866257. Epub 2019 Aug 2. PMID 31375035
- BACKGROUNDDiaz-Balboa E, Gonzalez-Salvado V, Rodriguez-Romero B, Martinez-Monzonis A, Pedreira-Perez M, Cuesta-Vargas AI, Lopez-Lopez R, Gonzalez-Juanatey JR, Pena-Gil C. Thirty-second sit-to-stand test as an alternative for estimating peak oxygen uptake and 6-min walking distance in women with breast cancer: a cross-sectional study. Support Care Cancer. 2022 Oct;30(10):8251-8260. doi: 10.1007/s00520-022-07268-z. Epub 2022 Jul 11. PMID 35819522
- BACKGROUNDWoods DL, Kishiyamaa MM, Lund EW, Herron TJ, Edwards B, Poliva O, Hink RF, Reed B. Improving digit span assessment of short-term verbal memory. J Clin Exp Neuropsychol. 2011 Jan;33(1):101-11. doi: 10.1080/13803395.2010.493149. PMID 20680884
- BACKGROUNDScarpina F, Tagini S. The Stroop Color and Word Test. Front Psychol. 2017 Apr 12;8:557. doi: 10.3389/fpsyg.2017.00557. eCollection 2017. PMID 28446889
- BACKGROUNDKee Shackelford DY, Brown JM, Peterson BM, Schaffer J, Hayward R (2017) The University of Northern Colorado Cancer Rehabilitation Institute Treadmill Protocol Accurately Measures VO2peak in Cancer Survivors . Int J Phys Med Rehabil 5: 437. doi: 10.4172/2329-9096.1000437
- BACKGROUNDSchmidt K, Vogt L, Thiel C, Jager E, Banzer W. Validity of the six-minute walk test in cancer patients. Int J Sports Med. 2013 Jul;34(7):631-6. doi: 10.1055/s-0032-1323746. Epub 2013 Feb 26.