- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07827274
Combining Moderate Aerobic Exercise With Inspiratory Muscle Training for Dialysis Patients With Atrial
Antiremodelling Effect of Moderate Intensity Aerobic Combined With Inspiratory Muscle Trainings on Kidney Dialysis With Atrial Fibrillation
Statement of the problem:
Is there a difference between of inspiratory muscle training with aerobic exercise or inspiratory muscle training for hemodialysis patients with AF??
Purpose of the study:
To find out the effect of combined inspiratory muscle training with aerobic exercise OR inspiratorty muscle traiting for hemodialysis CKD patients with atrial fibrillation as regards The following outcomes:
- medical state of patient (heart rate, blood pressure, oxygen saturation)
- lab analysis (GFR, Serum creatinine, blood urea and nitrogen (BUN) and INR)
- maximum Inspiratory pressure (MIP)
- period, duration of dialysis
- short form questionnaire(SF36)
- modified Borg scale
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: mahmoud I mahmoud, lecturer
- 전화번호: 00201142998414
- 이메일: Mahmoud.ibrahim@pt.bsu.edu.eg
연구 연락처 백업
- 이름: eman M abdallah, master degree
- 전화번호: 00201000665383
- 이메일: emem43332@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria
- Patients from both gender
- With chronic kidney failure(GFR>30)
- with atrial fibrillation
- Unemployed living a sedentary lifestyle
- Receive regular hemodialysis sessions at 2months ago
- All of them have vascular access through arteriovenous fistula
- Age range from 40-60 years
- Fully understand purpose and procedure of study
- Stable and have sufficient level of cognition and ability to understand instructions
exclusion Criteria: Patients who meet one of the following criteria will be excluded
- Real difficulties with understanding and signing The written informed consent
- Recent sequela of cerebrovascular accidents
- Osteoarticular or musculoskeletal diseases
- Un controlled systemic hypertension
- Un controlled diabetes
- Un stable angina
- Fever
- Infectious disease
- Acute respiratory failure
- Recent acute myocardial infarction
- Peripheral vascular diseases
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: group A inspiratory muscle training
intervention device(inspiratory muscle training) (inspiratory muscle trainingat 30% of maximal inspiratory pressure for20 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece.
The resistance is adjusted 30% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device.
A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set.
The resistance was adjusted every month at 30%of the new maximum pressura and if it remain the subject remain at the same level
|
intervention : (inspiratory muscle training) (inspiratory muscle training at 30% of maximal inspiratory pressure for20 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece.
The resistance is adjusted 30% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device.
A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set.
The resistance was adjusted every month at 30%of the new maximum pressura and if it remain the subject remain at the same level
|
|
활성 비교기: group B (Aerobic exercise+inspiratory muscle trainig )
interventions device ( Aerobic exercise +inspiratory muscle training) Aerobic exercise only 5-minute warm-up before exercise Each session started with a 5-minute bicycling warmup at 30%- 40% of HRR b) Active phase:
In addition, the exercise was performed in the first half of the dialysis session over a 3 months period for 3 sessions per week by cycling for 20 min at a moderate intensity(60%HR RESERVE) participants were trained to use stationary bicycle ergometer in a supine position for minimum of 30 minutes at each HD session. The speed, load, and duration were gradually increased with change of mode (automatic and passive). inspiratory muscle training) |
intervention : (inspiratory muscle training) (inspiratory muscle training at 30% of maximal inspiratory pressure for20 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece.
The resistance is adjusted 30% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device.
A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set.
The resistance was adjusted every month at 30%of the new maximum pressura and if it remain the subject remain at the same level
b) Active phase:
In addition, the exercise was performed in the first half of the dialysis session over a 3 months period for 3 sessions per week by cycling for 20 min at a moderate intensity(60%HR RESERVE) participants were trained to use stationary bicycle ergometer in a supine position for minimum of 30 minutes at each HD session. The speed, load, and duration were gradually increased with change of mode (automatic and passive). inspiratory muscle training) |
|
간섭 없음: control group c receive medical only
no exercise this group do assessment pre and post 3 months
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
6 minute walk test
기간: at the start of study and after intervention (3months)
|
6 minute walk test : (To detect functional capacity, carry out in a 20 -meter line along The passage way, The tape is placed every 30 meters .patients are instructed to walk The longest possible distance in 6 minutes continuously, turning around at The final Mark without stopping. they are further instructed to walk as far as they can for 6minutes without running or jogging, covered distance in meters is measured at the end of the rest for analysis |
at the start of study and after intervention (3months)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: sherien H mehani, professor, Beni _suef
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
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