Remotely Supervised Exercise During Chemotherapy in Women With Breast Cancer
- Sponsor
- Riga Stradins University
- Study ID
- NCT07716306
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 30 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Intervention Group — OTHERThe 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).
Study Details
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.
Key Dates
- First listed
- Jul 21, 2026
- Start date
- Jan 31, 2027
- Status verified
- Jul 2026
- Primary completion
- Mar 31, 2028
- Completion
- Oct 31, 2028
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- No Intervention: Control groupThe 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.
- Experimental: Intervention group
Primary Outcome Measure
Change in cardiorespiratory functioning, assessed by incremental test according to the University of Northern Colorado Cancer Rehabilitation Institute (UNCCRI) Treadmill protocol [ Time Frame: From baseline to 6 months after the intervention ]
Central Contacts
- Aija Klavina, PhD+371 29203488
- Sintija Liepina, Msc+371 27825885
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