Remotely Supervised Exercise During Chemotherapy in Women With Breast Cancer
ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-65
SponsorRiga Stradins University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
previously untreated primary breast cancer;
stage IIA-B, IIIA-C at diagnosis;
diagnosis established by core needle biopsy;
age 30-65 years;
Disqualifiers
cardiac pathologies (assessed by echocardiogram);
blood transfusion in the last six months;
another oncological disease;
previous chemotherapy, hormonal or X-ray treatment;
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention Group
Other interventionThe 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).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From baseline to 6 months after the intervention2
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.
Time frame
From baseline to 6 months after the intervention3
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.
Time frame
From baseline to 6 months after the interventionSecondary outcomes
1
Change in body composition assessed by Body Height (m)
Body height will be measured in meters
Time frame
From baseline to 6 months after the intervention2
Change in body composition assessed by Body Weight (kg)
Body weight will be measured in kilograms
Time frame
From baseline to 6 months after the intervention3
Change in body composition assessed by Body Mass Index (BMI)
Participant body weight and height will be combined to report BMI in kg/m\^2
Time frame
From baseline to 6 months after the intervention4
Change in physical functioning, assessed by 6 Minute Walk tests (6MWT)
Throughout the test, heart rate will be continuously recorded using a Polar H10 sensor. The test course will consist of a 30 m straight track located in an undisturbed indoor corridor, with turning points marked by cones. Participants will be instructed to walk back and forth along the course at their maximal tolerable walking pace, aiming to cover the greatest possible distance within the allotted time. Standardized verbal encouragement will be provided, and the remaining time will be announced at 1-minute intervals. The test will be terminated after exactly 6 minutes, at which point the total walking distance in meters will be recorded. Immediately following completion of the test, participants will rate their perceived exertion (RPE) using the Borg Scale. Data obtained will be analyzed using repeated-measures analysis and linear mixed-effects models.
Time frame
From baseline to 6 months after the interventionSponsors and contacts
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Source ClinicalTrials.gov
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