NCT05984823Befejeződött
Home-based Body Weight Exercise With Blood Flow Restriction (BFR): Feasibility of a Novel Rehabilitation Intervention in COPD Patients (HomeBFR-COPD)
Home-based Body Weight Exercise With Blood Flow Restriction (BFR): Feasibility of a Novel Rehabilitation Intervention in COPD Patients
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 24.
Rövid összefoglaló (regiszter, angolul)
The primary aim of this randomised controlled trial is to investigate the feasibility and acceptability of low-intensity exercise with blood flow restriction (BFR) in patients with Chronic Obstructive Pulmonary disease (COPD). The investigators will also collect functional and physiological outcome data to explore potential mechanisms and provide data for a power calculation to be used in a future randomised controlled trial (RCT) to ensure that subsequent full scale clinical RCT has maximum reach and benefit. The primary experimental hypothesis that underpins these aims is: • Low-intensity exercise with BFR is a tolerable, acceptable, and safe exercise modality in COPD patients. 40 patients attending clinics at University Hospitals of Leicester (UHL) National Health Service (NHS) Trust with diagnosed COPD will be randomly allocated to a home-based body weight exercise intervention either with or without the blood flow restriction (n=20 in each group). The body weight exercise will consist of five body weight exercises including: sitting knee extensions, standing knee raise, heel-toe raises, bilateral mini-squat behind a chair, and chair rise/sit to stand. In addition to the pre and post intervention visits, the initial two training sessions for both groups will be directly supervised in the research centre. These sessions are to ensure all exercises are performed correctly and safely and the patient become familiar with the exercises and BFR equipment and mobile application, which provides exercise guidance and session recording.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 27 (tényleges)
- Első benyújtás
- 2023. júl. 13.
- Kezdés
- 2024. jan. 26.
- Elsődleges befejezés
- 2024. nov. 4.
- Fő szponzor
- Mrs Hanoof Aljohani
- Betegségek
- Krónikus obstruktív tüdőbetegség (COPD)
- NCT-szám
- NCT05984823
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 27
- 2024. jan. 26. és az elsődleges befejezés (2024. nov. 4.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Scheduled elective surgery or other procedures requiring general anaesthesia during the study.
Más betegség
- Any major or uncontrolled comorbidity that would impair the participant's ability to exercise or would mean exercise was unsafe (e.g., uncontrolled diabetes, hypertension BP>160/100, muscle or joint injuries which would limit ability to exercise).
- Any other significant disease, disorder, or medical condition which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study including (but not limited to):
- Any clotting disorder Any bleeding disorder (e.g., haemophilia) Recent (<3 months) venous thromboembolism, vascular (artery or vein) surgery to the legs, skin graft to the legs, and or arteriovenous fistula in the legs.
- Had one or both legs immobilisation in the last 4 weeks (e.g., prolonged bed rest, or recent orthopaedic intervention) Taking any anticoagulant medication Significant peripheral neuropathy
Egyéb
- Unable to communicate sufficiently in English
- Unable to give informed consent or comply with testing and training protocol for any reason.
- Acute exacerbation in the preceding 4 weeks (would become eligible 4 weeks following recovery).
- Unable to undertake exercise due to physical or psychological barriers.
- Contraindication to exercise training (American College of Sports Medicine guidelines)
- Current or within the last 3 months (or maximum relevant wash out period, whichever is longer), participation in an investigational medicinal product (IMP) or device trial at the time of screening.
- Current or within the last 6 months (or maximum relevant wash out period, whichever is longer), participation in pulmonary rehabilitation or in another research study involving exercise training.
- Female participants who are pregnant, lactating, or planning pregnancy during the course of the study.
Kiket keres a vizsgálat
- Male or Female
- Aged 40 years or above
- Diagnosed with COPD as per GOLD criteria (Forced expiratory volume(FEV1)/forced vital capacity(FVC) <0.7)
- FEV1 ≤ 80% predicted
- Medical Research Council (MRC) dyspnoea scale ≥2
- BMI <= 35
- Willing and able to give informed consent for participation in the study.
- Stable dose of current regular medication for at least 4 weeks prior to study entry.
- Clinically acceptable ECG at enrolment.
- Able (in the investigators opinion) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Életkor a regiszterben: 40 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| NIHR Leicester Biomedical Research Centre - Respiratory | Leicester | Egyesült Királyság | Ismeretlen állapot |
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