Remotely Supervised Exercise During Chemotherapy in Women With Breast Cancer

NCT07716306 | Not Yet Recruiting

• 1 other identifier: RE-CARE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

Breast cancer; Quality of life; Physical health; Combined exercise; Aerobic exercise; Resistance training

Outcome Measures

Primary Outcomes (3)

• Change in cardiorespiratory functioning, assessed by incremental test according to the University of Northern Colorado Cancer Rehabilitation Institute (UNCCRI) Treadmill protocol

  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.

  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)

  Participants will be asked to complete the EORTC QLQ-C30, a 30-item questionnaire, electronically. This instrument includes a global health status/quality-of-life scale and multiple functional subscales (physical, emotional, cognitive, social, and role functioning). It further incorporates several symptom subscales assessing fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Patients respond to the items using Likert scale (1 = "Not at all," 2 = "A little," 3 = "Quite a bit," and 4 = "Very much"). All scales and single-item measures yield scores ranging from 0 to 100%. For the functional scales, higher scores indicate better functioning, but for the symptom scales, higher scores reflect greater symptom severity. Data obtained will be analyzed using repeated-measures analysis and linear mixed-effects models.

  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.

  In addition, participants will complete the EORTC QLQ-BR23, a 23-item, breast cancer-specific questionnaire that includes functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and symptom scales (systemic therapy side effects, breast symptoms, arm symptoms). Patients respond to the items using Likert scale (1 = "Not at all," 2 = "A little," 3 = "Quite a bit," and 4 = "Very much"). All scales and single-item measures yield scores ranging from 0 to 100%. Data obtained will be analyzed using repeated-measures analysis and linear mixed-effects models.

  From baseline to 6 months after the intervention

Secondary Outcomes (11)

• Change in body composition assessed by Body Height (m)

  From baseline to 6 months after the intervention

• Change in body composition assessed by Body Weight (kg)

  From baseline to 6 months after the intervention

• Change in body composition assessed by Body Mass Index (BMI)

  From baseline to 6 months after the intervention

• Change in physical functioning, assessed by 6 Minute Walk tests (6MWT)

  From baseline to 6 months after the intervention

• Change in lower limb strength, assessed by 30 second sit to stand (30STS)

  From baseline to 6 months after the intervention

Study Arms (2)

Control group

NO INTERVENTION

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.

Intervention group

EXPERIMENTAL

Other: Intervention Group

Interventions

Intervention Group OTHER

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 applications (Resistance Band Tracker and Polar Flow).

Intervention group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riga Stradins University: lead

Study Sites (1)

Riga Stradins University

Riga, LV1007, Latvia

Location

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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/s00520-022-07268-z. Epub 2022 Jul 11.

  PMID: 35819522 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Aija Klavina, PhD

CONTACT

+371 29203488; aija.klavina@rsu.lv

Sintija Liepina, Msc

CONTACT

+371 27825885; sintija.liepina@rsu.edu.lv

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Aija Klavina, principal investigator, lead researcher at the Laboratory of Sports and nutrition research (RSU) and professor at the Lithuanian Sport University, Department of Rehabilitation and Health promotion.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)