Remotely Supervised Exercise During Chemotherapy in Women With Breast Cancer

Официальное название

Effect of Remotely Supervised Combined Aerobic and Resistance Exercise Training on Physical Health and Quality of Life in Women With Breast Cancer During Chemotherapy

Обзор

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.

Подробное описание

Participants in the RE-CARE intervention group will be scheduled for 2-3 training sessions per week on non-consecutive days throughout the entire chemotherapy period (\~24 weeks), ensuring no more than 48 hours elapse between two sessions. Each participant will first complete a 30-40 minute individualized introductory session to learn correct exercise techniques using the training equipment.

Each aerobic high intensity interval training session will begin with a 6-minute warm-up at a self-selected walking speed gradually increasing to moderate intensity (approximately 60-70% HRmax), corresponding to 4 on the Modified Borg scale (moderate perceived exertion) by the end of the warm-up. Following this, the main segment will consist of four 4-minute walking intervals at 85-95% HRmax (7-8 on the Modified Borg scale). Each 4-minute high-intensity interval will be interspersed with 3 minutes of active recovery at 55-70% HRmax (4 on the Modified Borg scale). The total duration of session will therefore be 34 minutes.

For resistance training, participants will perform 3-4 sets of 6 repetitions, with a 2-minute rest interval between sets. The initial workload will be set at 70% of the participant's estimated one-repetition maximum (1RM), corresponding to 6-7 on the Modified Borg scale, and will be increased to 80% (7-8 on the Modified Borg scale) once participants are able to complete more than 6 repetitions. The RT program will target major muscle groups of the legs, shoulders, and arms. Each RT session will last 35 minutes in total, including a 6-minute warm-up and a 3-minute cool-down.

Вмешательства

• Другое Intervention Group
  The intervention group will receive remotely supervised sessions conducted by health professionals approximately three times per week for 24 weeks, ensuring no more than 48 hours elapse between two sessions. Individually customized aerobic high intensity interval and resistance training sessions will be carried out on alternating days using a smartwatch, heart rate monitor (polar H10 sensor), resistance bands with real-time monitoring sensors (bandcizer sensor), and the linked smartphone applica

Первичные конечные точки

• Change in cardiorespiratory functioning, assessed by incremental test according to the University of Northern Colorado Cancer Rehabilitation Institute (UNCCRI) Treadmill protocol [Срок оценки: From baseline to 6 months after the intervention]
• Change in Health-Related Quality of Life, assessed by European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire-Core 30 (EORTC QLQ-C30) [Срок оценки: From baseline to 6 months after the intervention]
• Change in Health-Related Quality of Life, assessed by European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire - Breast Specific module EORTC QLQ-BR23. [Срок оценки: From baseline to 6 months after the intervention]

Вторичные конечные точки (11)

• Change in body composition assessed by Body Height (m) [Срок оценки: From baseline to 6 months after the intervention]
• Change in body composition assessed by Body Weight (kg) [Срок оценки: From baseline to 6 months after the intervention]
• Change in body composition assessed by Body Mass Index (BMI) [Срок оценки: From baseline to 6 months after the intervention]
• Change in physical functioning, assessed by 6 Minute Walk tests (6MWT) [Срок оценки: From baseline to 6 months after the intervention]
• Change in lower limb strength, assessed by 30 second sit to stand (30STS) [Срок оценки: From baseline to 6 months after the intervention]
• Change in lower limb strength, assessed by 5x sit to stand (5xSTS) [Срок оценки: From baseline to 6 months after the interventio]
• Change in upper limb strength, assessed by handgrip dynamometer [Срок оценки: From baseline to 6 months after the intervention]
• Change in cognitive functioning, assessed by Digit Span test [Срок оценки: From baseline to 6 months after the intervention]
• Change in cognitive functioning, assessed by Stroop test [Срок оценки: From baseline to 6 months after the intervention]
• Change in cognitive functioning, assessed by The Wisconsin Card Sorting Test [Срок оценки: From baseline to 6 months after the intervention]
• Change in Health-Related Quality of Life, assessed by Weekly Health Monitoring [Срок оценки: From baseline to 6 months after the intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Латвия · 1 центр

• Riga Stradins University — Riga

Публикации

• Klavina 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
• Kopp 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
• Diaz-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/s00520-022-07 PMID 35819522
• Woods 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
• Scarpina 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
• Kee 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
• Schmidt 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. PMID 23444095
• Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116. PMID 31626055

Идентификаторы

NCT: NCT07716306 · RE-CARE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗