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Breast CancerNCT07716306

Remotely Supervised Exercise During Chemotherapy in Women With Breast Cancer

A study testing Intervention Group in people with Breast Cancer, run by Riga Stradins University at 1 site in Latvia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 30 to 65 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteLatvia
Study dates
Jan 2027to Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aija Klavina, PhD contact

+371 29203488

aija.klavina@rsu.lv

Sintija Liepina, Msc contact

+371 27825885

sintija.liepina@rsu.edu.lv

Latvia1 site

  • Riga Stradins University

    Riga, LV1007

    Aija Klavina, PhD, +371 29203488, aija.klavina@rsu.lv

Other trials in Latvia

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Being tested
Intervention Group
Keywords
Breast cancer, Quality of life, Physical health, Combined exercise, Aerobic exercise, Resistance training
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention GroupOther

    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).

Study groups in NCT07716306
Study groupRoleWhat they receive
Control groupNo interventionThe 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 groupExperimentalNot described
Receives: Other: Intervention Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From baseline to 6 months after the intervention

  2. 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.

    Measured: From baseline to 6 months after the intervention

  3. 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.

    Measured: From baseline to 6 months after the intervention

Secondary outcomes (11)

  1. Change in body composition assessed by Body Height (m)

    Body height will be measured in meters

    Measured: From baseline to 6 months after the intervention

  2. Change in body composition assessed by Body Weight (kg)

    Body weight will be measured in kilograms

    Measured: From baseline to 6 months after the intervention

  3. 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

    Measured: From baseline to 6 months after the intervention

  4. 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.

    Measured: From baseline to 6 months after the intervention

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

    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.

    Measured: From baseline to 6 months after the intervention

  6. Change in lower limb strength, assessed by 5x sit to stand (5xSTS)

    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.

    Measured: From baseline to 6 months after the interventio

  7. Change in upper limb strength, assessed by handgrip dynamometer

    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.

    Measured: From baseline to 6 months after the intervention

  8. Change in cognitive functioning, assessed by Digit Span test

    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.

    Measured: From baseline to 6 months after the intervention

  9. Change in cognitive functioning, assessed by Stroop test

    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.

    Measured: From baseline to 6 months after the intervention

  10. Change in cognitive functioning, assessed by The Wisconsin Card Sorting Test

    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.

    Measured: From baseline to 6 months after the intervention

  11. Change in Health-Related Quality of Life, assessed by Weekly Health Monitoring

    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.

    Measured: From baseline to 6 months after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionMar 2028 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07716306
Sponsor's protocol ID
RE-CARE
Status last verified
Jul 2026
First submitted
22 Jun 2026
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39548802

  • 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.

    PubMed 31375035

  • 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.

    PubMed 35819522

  • 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.

    PubMed 20680884

  • 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.

    PubMed 28446889

  • 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

  • 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.

    PubMed 23444095

  • 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.

    PubMed 31626055

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Group in people with Breast Cancer, run by Riga Stradins University at 1 site in Latvia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aija Klavina, PhD (+371 29203488, aija.klavina@rsu.lv), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07716306, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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