- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07805330
Effects of Blood Flow Restriction Rehabilitation on Functional Mobility and Balance Among Chronic Obstructive Pulmonary Disease Patients.
Effects of Blood Flow Restriction Rehabilitation on Functional Mobility and Balance Among Chronic Obstructive Pulmonary Disease Patients
Background: Chronic obstructive pulmonary disease (COPD) is a common lung disease causing restricted airflow and breathing problems. It is sometimes called emphysema or chronic bronchitis. The damage results in swelling and irritation, also called inflammation, inside the airways that limit airflow into and out of the lungs. BFR Rehabilitation is effective in improving functional mobility and balance among COPD patients.
Objective: To find out the effects of Blood Flow Restriction (BFR) Rehabilitation on functional mobility and balance among COPD (Chronic Obstructive Pulmonary Disease) patients.
Methods: A Randomized Controlled Trial Study was conducted at Gulab Devi Hospital, Hameed Latif Hospital and Arif Memorial Teaching Hospital Lahore. Fifty patients of age 45-60 years with COPD were randomized into two groups. Allocation of patients in two equal groups by lottery method will be through random assignment. Group A was treated with controlled physical therapy while Group B was treated with BFR rehabilitation. Controlled treatment includes low intensity resistance exercises while BFR Rehabilitation includes use of a tourniquet with low intensity resistance exercises. All this information will be collected through a pulse oximeter. Berg Balance Scale will be used for balance and timed up and go test for functional mobility.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Aleena Waheed, Masters in Physical Therapy
- 전화번호: 03214883868
- 이메일: alwaheed28@gmail.com
연구 장소
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Lahore, 파키스탄, 54900
- 모병
- Arif Memorial Teaching Hospital
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연락하다:
- Aleena Waheed
- 전화번호: 03214883868
- 이메일: alwaheed28@gmail.com
-
수석 연구원:
- Harmeen Nadeem, Doctor of Physical Therapy
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Subjects who are clinically stable before study
- Forced expiratory volume in 1s (FEV1)/forced vital capacity (FVC)<70% and FEV1 ≥30% but <80% respectively
- Subjects who will be willing to take part in this study
Exclusion Criteria:
- Upper abdominal surgery
- Lung cancer
- Open fracture
- Mental disorder
- Active malignancy
- Severe hypertension
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Resistance Exercise without tourniquet
The control group performed the same above-mentioned resistance training without the pressure cuff under the supervision of physiotherapist.
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The control group performed the same above-mentioned resistance training without the pressure cuff under the supervision of physiotherapist.
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실험적: Blood flow restriction resistance exercise
Blood flow restriction resistance exercise (BFR-RE), or Kaatsu training, was developed by Dr. Yoshiaki Sato over 40 years ago.
It uses a low load (15-30% 1-RM) to induce gains in muscle strength and mass.
External pressure (~80% limb occlusion pressure, LOP) is applied via a tourniquet cuff to the proximal limb, restricting venous return while allowing partial arterial inflow, creating blood pooling in distal muscles.
Training was supervised by BFR-certified physiotherapists using medium-sized cuffs, placed at the proximal thigh for a maximum of 10 minutes.
Pressure was auto-adjusted to personalized LOP, inflated before the first set, maintained during rests, and deflated post-session.
Each session trained a single limb, alternated on different days, 2-3 times/week.
Exercises included isotonic knee extensions from 150° to 180°: 1 set of 30 reps, then 3 sets of 15 reps, with 30-second rests, at 1-2 sec/repetition, using sandbag resistance (15-30% 1-RM).
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Blood flow restriction resistance exercise (BFR-RE), or Kaatsu training, was developed by Dr. Yoshiaki Sato over 40 years ago.
It uses a low load (15-30% 1-RM) to induce gains in muscle strength and mass.
External pressure (~80% limb occlusion pressure, LOP) is applied via a tourniquet cuff to the proximal limb, restricting venous return while allowing partial arterial inflow, creating blood pooling in distal muscles.
Training was supervised by BFR-certified physiotherapists using medium-sized cuffs, placed at the proximal thigh for a maximum of 10 minutes.
Pressure was auto-adjusted to personalized LOP, inflated before the first set, maintained during rests, and deflated post-session.
Each session trained a single limb, alternated on different days, 2-3 times/week.
Exercises included isotonic knee extensions from 150° to 180°: 1 set of 30 reps, then 3 sets of 15 reps, with 30-second rests, at 1-2 sec/repetition, using sandbag resistance (15-30% 1-RM).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Balance
기간: Pre intervention and 4 weeks post intervention
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Balance was assessed using the Berg Balance Scale (BBS), a widely used clinical tool that evaluated functional balance through 14 tasks of varying difficulty.
Each task was scored from 0-4, with a maximum score of 56.
Higher scores indicated better balance, while lower scores reflected greater fall risk.
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Pre intervention and 4 weeks post intervention
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Oxygen Saturation
기간: Pre intervention and 4 weeks post intervention
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Oxygen saturation reflects the percentage of haemoglobin carrying oxygen, normally ranging between 95-100% in healthy individuals.
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Pre intervention and 4 weeks post intervention
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Respiratory rate
기간: Pre-intervention and 4 weeks post-intervention
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Respiratory rate will be measured using a pulse oximeter and recorded as the number of breaths taken per minute.
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Pre-intervention and 4 weeks post-intervention
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Heart Rate
기간: Pre-intervention and 4 weeks post-intervention
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Heart rate will be measured using a pulse oximeter and recorded as the number of heartbeats per minute.
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Pre-intervention and 4 weeks post-intervention
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공동 작업자 및 조사자
수사관
- 수석 연구원: Harmeen Nadeem, Arif Memorial Teaching Hospital
간행물 및 유용한 링크
일반 간행물
- Kohlbrenner D, Kuhn M, Manettas A, Aregger C, Peterer M, Greco N, Sievi NA, Clarenbach C. Low-load blood flow restriction strength training in patients with COPD: a randomised single-blind pilot study. Thorax. 2024 Mar 15;79(4):340-348. doi: 10.1136/thorax-2023-220546.
- Lamberti N, Straudi S, Donadi M, Tanaka H, Basaglia N, Manfredini F. Effectiveness of blood flow-restricted slow walking on mobility in severe multiple sclerosis: A pilot randomized trial. Scand J Med Sci Sports. 2020 Oct;30(10):1999-2009. doi: 10.1111/sms.13764. Epub 2020 Jul 25.
- Clarkson MJ, May AK, Warmington SA. Chronic Blood Flow Restriction Exercise Improves Objective Physical Function: A Systematic Review. Front Physiol. 2019 Aug 21;10:1058. doi: 10.3389/fphys.2019.01058. eCollection 2019.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB/2024/209
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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