Remotely Supervised Exercise During Chemotherapy in Women With Breast Cancer

July 16, 2026 updated by: Aija Klavina, Riga Stradins University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Latvia
      • Riga, Latvia, LV1007
        • Riga Stradins University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Other: 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 applications (Resistance Band Tracker and Polar Flow).
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: 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.
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.
Time Frame: 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.
From baseline to 6 months after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in body composition assessed by Body Height (m)
Time Frame: From baseline to 6 months after the intervention
Body height will be measured in meters
From baseline to 6 months after the intervention
Change in body composition assessed by Body Weight (kg)
Time Frame: From baseline to 6 months after the intervention
Body weight will be measured in kilograms
From baseline to 6 months after the intervention
Change in body composition assessed by Body Mass Index (BMI)
Time Frame: From baseline to 6 months after the intervention
Participant body weight and height will be combined to report BMI in kg/m^2
From baseline to 6 months after the intervention
Change in physical functioning, assessed by 6 Minute Walk tests (6MWT)
Time Frame: 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.
From baseline to 6 months after the intervention
Change in lower limb strength, assessed by 30 second sit to stand (30STS)
Time Frame: 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.
From baseline to 6 months after the intervention
Change in lower limb strength, assessed by 5x sit to stand (5xSTS)
Time Frame: 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.
From baseline to 6 months after the interventio
Change in upper limb strength, assessed by handgrip dynamometer
Time Frame: 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.
From baseline to 6 months after the intervention
Change in cognitive functioning, assessed by Digit Span test
Time Frame: 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.
From baseline to 6 months after the intervention
Change in cognitive functioning, assessed by Stroop test
Time Frame: 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.
From baseline to 6 months after the intervention
Change in cognitive functioning, assessed by The Wisconsin Card Sorting Test
Time Frame: 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.
From baseline to 6 months after the intervention
Change in Health-Related Quality of Life, assessed by Weekly Health Monitoring
Time Frame: 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.
From baseline to 6 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riga Stradins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RE-CARE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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