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Remotely Supervised Exercise During Chemotherapy in Women With Breast Cancer

16. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

      • Riga, Lettland, LV1007
        • Rīga Stradiņš University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Interventionsgruppe
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).
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in cardiorespiratory functioning, assessed by incremental test according to the University of Northern Colorado Cancer Rehabilitation Institute (UNCCRI) Treadmill protocol
Zeitfenster: 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)
Zeitfenster: 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.
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in body composition assessed by Body Height (m)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Januar 2027

Primärer Abschluss (Geschätzt)

1. März 2028

Studienabschluss (Geschätzt)

1. Oktober 2028

Studienanmeldedaten

Zuerst eingereicht

22. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Juli 2026

Zuerst gepostet (Tatsächlich)

21. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • RE-CARE

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .