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De klinische studie NCT07386444 (IMACT) voor Vroege stadium borstcarcinoom, Dyspneu is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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Inspiratory Muscle Training for Breast Cancer Patients on Chemotherapy (IMACT) 58 Lichaamsbeweging

Rekruterend
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De klinische studie NCT07386444 (IMACT) is een interventioneel studie bij Vroege stadium borstcarcinoom, Dyspneu met de status rekruterend. Het doel is om 58 deelnemers te includeren vanaf 19 februari 2026. De studie wordt geleid door Ohio State University en de voltooiing is gepland op 31 december 2026. Laatste update op ClinicalTrials.gov: 4 februari 2026.
Beknopte samenvatting
This clinical trial studies whether breathing exercises for the muscles that help with breathing air in, inspiratory muscle training (IMT), works to improve breathing muscle strength, shortness of breath, and physical activity levels in women who are receiving chemotherapy for early-stage breast cancer (BC). Cancer and/or treatments for BC can directly result in muscle wasting that involves breathing muscles, skeleta...Toon meer
Uitgebreide beschrijving
PRIMARY OBJECTIVE: To investigate the effects of 8 weeks of IMT on inspiratory muscle strength, exertional dyspnea, and physical activity levels among women undergoing chemotherapy for BC.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients complete three sets of fifteen repetitions per session of low-intensity IMT over 15-20 minutes four days a week for 8 weeks.

ARM 2: Patients complete three sets of...

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Officiële titel

Effects of Inspiratory Muscle Training Among Breast Cancer Patients Undergoing Active Treatment (IMACT)

Aandoeningen
Vroege stadium borstcarcinoomDyspneu
Andere studie-ID's
NCT-ID
NCT07386444
Startdatum (Werkelijk)
2026-02-19
Laatste update geplaatst
2026-02-04
Verwachte einddatum
2026-12-31
Inschrijving (Geschat)
58
Studietype
Interventioneel
FASE
N.v.t.
Status
Rekruterend
Primaire doel
Ondersteunende zorg
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Enkelblind
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
Actieve comparatorArm 1 (low-intensity IMT)
Patients complete three sets of fifteen repetitions per session of low-intensity IMT over 15-20 minutes four days a week for 8 weeks.
Inspiratoire spiertraining
Training of respiratory muscles
ExperimenteelArm 2 (high-intensity IMT)
Patients complete three sets of fifteen repetitions per session of high-intensity IMT over 15-20 minutes four days a week for 8 weeks.
Inspiratoire spiertraining
Training of respiratory muscles
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Maximum inspiratory pressure
Measure of the strength of the inspiratory muscles. Units: cm H20
Baseline to 8 weeks
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Physical activity levels
Number of steps/day averaged weekly.
Baseline to 8 weeks
Modified Medical Research Council Dyspnea scale rating
Patients will indicate the extent to which their dyspnea affects mobility using a one question 1-5 scale; higher scores indicate greater respiratory disability.
Baseline to 8 weeks
Dyspnea 12 score
Questionnaire consists of 12 descriptor items such as "I feel short of breath" and "my breathing is uncomfortable" with each item rated on a scale of none (0), mild (1), moderate (2), or severe (3). Individual items are summed to generate a total score (0 to 36), with a higher score indicating worse dyspnea
Baseline to 8 weeks
RAND-36 Quality of life
8 subdomains will be scored 0-100 with higher scores reflecting better perceived quality of life.
Baseline to 8 weeks
FACIT-F
Version 4 is a 40-item measure that will be used to assess self-reported fatigue and its impact on daily activities and function over the past 7 days. It is a 5-point Likert-type scale with five subdomains including physical well-being, social/family well-being, emotional well-being, functional well-being, and fatigue yielding a total score from 0-52.
Baseline to 8 weeks
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Vrouw
  • Age ≥ 18 years
  • Within 3 weeks of starting chemotherapy for an early-stage breast cancer diagnosis
  • Able to exercise independently without needing support
  • Ability to read, speak, understand English

  • Metastatic breast cancer
  • Unwilling or unable to follow protocol requirements
  • Any significant health condition which in the investigator's opinion increases the risks of participation or makes the participant unsuitable for the study
Ohio State University Comprehensive Cancer Center logoOhio State University
Verantwoordelijke instantie
Dharini Bhammar, Hoofdonderzoeker, Principal Investigator, Ohio State University Comprehensive Cancer Center
Centraal Contactpersoon
Contact: The Ohio State University Comprehensive Cancer Center, 800-293-5066, [email protected]
Contact: Dharini Bhammar, 614-366-9467, [email protected]
1 Studielocaties in 1 landen

Ohio

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States
Dharini M. Bhammar, MBBS, PhD, Contact, 614-366-9467, [email protected]
Dharini M. Bhammar, MBBS, PhD, Hoofdonderzoeker
Rekruterend