Breast Cancer
Conditions
Keywords
Breast cancer, Quality of life, Physical health, Combined exercise, Aerobic exercise, Resistance training
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.
Detailed description
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.
Interventions
OTHERIntervention 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 applications (Resistance Band Tracker and Polar Flow).
Sponsors
Riga Stradins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cardiorespiratory functioning, assessed by incremental test according to the University of Northern Colorado Cancer Rehabilitation Institute (UNCCRI) Treadmill protocol | From baseline to 6 months after the intervention | 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. |
| 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) | From baseline to 6 months after the intervention | 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. |
| 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. | From baseline to 6 months after the intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body composition assessed by Body Height (m) | From baseline to 6 months after the intervention | Body height will be measured in meters |
| Change in body composition assessed by Body Weight (kg) | From baseline to 6 months after the intervention | Body weight will be measured in kilograms |
| Change in body composition assessed by Body Mass Index (BMI) | From baseline to 6 months after the intervention | Participant body weight and height will be combined to report BMI in kg/m\^2 |
| Change in physical functioning, assessed by 6 Minute Walk tests (6MWT) | From baseline to 6 months after the intervention | 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. |
| Change in lower limb strength, assessed by 30 second sit to stand (30STS) | From baseline to 6 months after the intervention | Participants will be instructed to rise from a chair without using their hands, performing as fast as possible and as many repetitions as possible within 30 seconds. Higher performance scores will be interpreted as better lower body muscle strength and greater functional independence. Data obtained will be analyzed using repeated-measures analysis and linear mixed-effects models. |
| Change in lower limb strength, assessed by 5x sit to stand (5xSTS) | From baseline to 6 months after the interventio | Participants will be instructed to rise from a chair without using their hands, performing five repetitions as fast as possible. Results will be measured in seconds. Higher performance scores will be interpreted as better lower body muscle strength and greater functional independence. Data obtained will be analyzed using repeated-measures analysis and linear mixed-effects models. |
| Change in upper limb strength, assessed by handgrip dynamometer | From baseline to 6 months after the intervention | Participants will be instructed to squeeze the device as hard as possible. They will be asked to apply the force in a smooth, continuous manner, avoiding any jerking movements or rapid wrenching of the device. Each participant will perform three trials during a single assessment session and scores will be measured in kg. Higher performance scores will be interpreted as better upper-body muscular strength. Data obtained will be analyzed using repeated-measures analysis and linear mixed-effects models. |
| Change in cognitive functioning, assessed by Digit Span test | From baseline to 6 months after the intervention | Measures of forward and backward digit span are among the oldest and most widely used neuropsychological tests of short-term verbal memory.Throughout the digit span tasks, participants will be presented with a sequence of digits and instructed to repeat them in the identical order. Afterwards participants will be presented with another series of digits but required to repeat the sequence in reverse order. Following parameters will be evaluated: 1) Span Length 2) Total Score. Data obtained will be analyzed using repeated-measures analysis and linear mixed-effects models. |
| Change in cognitive functioning, assessed by Stroop test | From baseline to 6 months after the intervention | Stroop test assesses the ability to inhibit cognitive interference, which occurs when the processing of a stimulus feature affects the simultaneous processing of another attribute of the same stimulus. It measures attention, processing speed, cognitive flexibility and working memory. Participants will be shown color words printed in inconsistent ink colors (for example, the word "red" printed in green ink). They will be instructed to name the ink color rather than read the word. Two primary kinds of units will be used for measurement: time and number of errors. Data obtained will be analyzed using repeated-measures analysis and linear mixed-effects models. |
| Change in cognitive functioning, assessed by The Wisconsin Card Sorting Test | From baseline to 6 months after the intervention | The Wisconsin Card Sorting Test was developed to assess abstraction and the ability to shift cognitive strategies in response to changing environmental contingencies. It is considered a measure of executive function. During the tests four cards (a red triangle, two green stars, three yellow crosses, and four blue circles) will be placed in front of the participant. The participants will be shown a set of response cards that can be matched to the stimulus cards based on color, shape or number. Multiple parameters will be evaluated: 1) number of correct sorts, 2) categories 3) perseverative errors, 4) set-loss errors. Data obtained will be analyzed using repeated-measures analysis and linear mixed-effects models. |
| Change in Health-Related Quality of Life, assessed by Weekly Health Monitoring | From baseline to 6 months after the intervention | Participants will be requested to complete a weekly electronic survey consisting of seven questions. Questions will address commonly observed chemotherapy-related adverse effects: physical functioning; psychological functioning; pain; fatigue; social functioning and sleep quality. For each domain, participants will indicate the duration of symptom occurrence using the following response options: every day, 5-6 days, 3-4 days, 1-2 days, or none of the days. In addition, five specific chemotherapy-related symptoms (i.e., nausea, vomiting, constipation, numbness in the legs or arms, and rash/ulceration of the skin) will be listed at the end of the survey. Data obtained will be analyzed using repeated-measures analysis and linear mixed-effects models. |
Countries
Latvia
Contacts
CONTACTAija Klavina, PhD
CONTACTSintija Liepina, Msc
Outcome results
None listed