- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07648524
Influence of Cardiopulmonary Rehabilitation on Cardiorespiratory Adaptation in Patients With Pulmonary Hypertension
Influence of Cardiopulmonary Rehabilitation on Cardiorespiratory Adaptation in Patients With Pulmonary Hypertension: A Comparative Experimental Study
연구 개요
상태
상세 설명
Pulmonary hypertension is a progressive disease associated with reduced exercise capacity, respiratory muscle weakness, and impaired quality of life. Exercise training and respiratory muscle training have been shown to improve physical performance and quality of life in patients with pulmonary hypertension.
forty-two medically stable patients with Group III pulmonary hypertension due to lung diseases (obstructive and restrictive) will participate in this comparative experimental study. Participants will receive cardiopulmonary rehabilitation consisting of moderate-intensity interval aerobic training and inspiratory muscle training in addition to routine medical treatment. Outcome measures will include echocardiographic parameters, pulmonary function, six-minute walk distance, estimated VO2max, dyspnea severity, and quality of life. The study aims to evaluate the influence of cardiopulmonary rehabilitation on cardiorespiratory adaptation in patients with pulmonary hypertension.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Rana Essam El Din Abd Elbar, Assistant lecturer
- 전화번호: 01013981766
- 이메일: rana.essam@acu.edu.eg
연구 장소
-
-
-
Giza, 이집트
- Faculty of Physical Therapy ,Cairo University
-
연락하다:
- Rana Essam El Din Abd Elbar, Assistant lecturer
- 전화번호: 01013981766
- 이메일: rana.essam@acu.edu.eg
-
연락하다:
- Rana Essam El Din Abd Elbar, assistant lect P.T
- 이메일: rana.essam@acu.edu.eg
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- a)Medically stable pulmonary hypertension patients who were under optimized medical therapy. b)Pulmonary artery pressure ≥ 25 mmHg confirmed by RT side heart catheterization.
c)Forty two male patients with group 3 pulmonary hypertension (Chest cause) include Obstructive lung disease ( COPD and sleep apnea ) and restrictive lung disease (ILD). d)The patients' ages will range from 45 to 65 years old. e)BMI (25 - 34.9) kg/m2. f)World Health Organization (WHO) classification of functional classes II to III ( class II are patients with pulmonary hypertension who have a mild limitation of physical activity )(class III are patients with pulmonary hypertension who have a marked limitation of physical activity
Exclusion Criteria:
g)Uncontrolled systemic HTN. h)Other types of pulmonary hypertension.. i)Smoker j)Any condition of kidney failure. k)Neurological or musculoskeletal conditions that interfere with gait
l)Impaired vision and/or hearing.
m)Patients who are unable to follow verbal instructions. n)acute exacerbation condition. o)unstable angina, serious cardiac dysrhythmias on resting ECG.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: group III PH with obstructive lung disease
Group (A), (n =16) patients with group III PH with obstructive lung disease will receive cardiopulmonary Rehabilitation in the form of moderate-intensity interval aerobic training and inspiratory muscle training in addition to the routine medical treatment.
|
Training will be conducted on a treadmill three times weekly for 12 weeks.
Exercise intensity will progress from 30-40% to 60-70% of target heart rate.
Each session will last 30 minutes and include warm-up and cool-down periods.
inspiratory muscle training will be performed using a Threshold Inspiratory Muscle Trainer (Philips Respironics).
Training intensity will correspond to moderate-to-severe effort (3-5 on the Modified Borg Scale).
|
|
실험적: group III PHT with restrictive lung disease
group (B), (n =16) patients with group III PHT with restrictive lung disease will receive cardiopulmonary rehabilitation in the form of moderate-intensity interval aerobic training and inspiratory muscle training in addition to the routine medical treatment.
|
Training will be conducted on a treadmill three times weekly for 12 weeks.
Exercise intensity will progress from 30-40% to 60-70% of target heart rate.
Each session will last 30 minutes and include warm-up and cool-down periods.
inspiratory muscle training will be performed using a Threshold Inspiratory Muscle Trainer (Philips Respironics).
Training intensity will correspond to moderate-to-severe effort (3-5 on the Modified Borg Scale).
|
|
실험적: control group III PH with obstructive lung disease
Group (c), (n =5) patients with group III PH with obstructive lung disease will receive medical treatment only
|
medication
|
|
실험적: control group III PHT with restrictive lung disease
Group (D), (n =5) patients with group III PH with restrictive lung disease will receive medical treatment only
|
medication
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
6-minute walk distance
기간: 12 weeks
|
total distance walked in 6 minutes
|
12 weeks
|
|
Maximal Oxygen Consumption
기간: 12weeks
|
Estimated VO2max
|
12weeks
|
|
spirometry
기간: 12weeks
|
FEV1, FVC, FEV1/FVC, MVV
|
12weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Dyspnea Severity
기간: 12weeks
|
Modified Borg Scale
|
12weeks
|
|
change Pulmonary Artery Pressure
기간: 12weeks
|
pulmonary artery pressure estimated by ECHO
|
12weeks
|
|
change of total score of SF-12 Questionnaire) Quality of Life
기간: 12weeks
|
more increase scores more increase quality of life
|
12weeks
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: NESREEN GHAREEB MOHAMED EL-NAHAS, Prof PT, faculty of P.T. Cairo University
- 연구 의자: HEBA AHMED ALI ABDEEN, Prof, faculty of P.T. Cairo University
- 연구 의자: HEND ABD EL-MONAEM ABD EL-MONAEM, Lecturer of physical therapy, faculty of P.T. Cairo University
- 연구 의자: REEM IBRAHIM EL KORASHY, prof of pulmonology, Cairo University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
기타 연구 ID 번호
- P.T.REC/012/005518
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .