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临床试验/NCT07827274
NCT07827274尚未招募不适用

Antiremodelling Effect of Moderate Intensity Aerobic Combined With Inspiratory Muscle Trainings on Kidney Dialysis With Atrial Fibrillation

Beni-Suef University0 个研究点目标入组 45 人开始时间: 2026年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
45
主要终点
6 minute walk test

研究概览

简要总结

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:

  1. medical state of patient (heart rate, blood pressure, oxygen saturation)
  2. lab analysis (GFR, Serum creatinine, blood urea and nitrogen (BUN) and INR)
  3. maximum Inspiratory pressure (MIP)
  4. period, duration of dialysis
  5. short form questionnaire(SF36)
  6. modified Borg scale

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • Infectious disease
  • Acute respiratory failure
  • Recent acute myocardial infarction
  • Peripheral vascular diseases

研究组 & 干预措施

group A inspiratory muscle training

Active Comparator

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

干预措施: inspiratoy muscle training (Device)

group B (Aerobic exercise+inspiratory muscle trainig )

Active Comparator

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:

  • Mode:moderte -intensity interval aerobic training (MIIT).
  • Intensity: With MODERTE intensity continous of 60 %of heart rate reserve (HRR) monitored by ECG and a 5-minute cool-down following exercise at intensity (30- 40%HR RESERVE) were carried out each time.

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)

干预措施: inspiratoy muscle training (Device)

group B (Aerobic exercise+inspiratory muscle trainig )

Active Comparator

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:

  • Mode:moderte -intensity interval aerobic training (MIIT).
  • Intensity: With MODERTE intensity continous of 60 %of heart rate reserve (HRR) monitored by ECG and a 5-minute cool-down following exercise at intensity (30- 40%HR RESERVE) were carried out each time.

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)

干预措施: Aerobic exercise +inspiratory muscle training (Device)

control group c receive medical only

No Intervention

no exercise this group do assessment pre and post 3 months

结局指标

主要结局

6 minute walk test

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

eman mohamed ahmed abdallah

physiotherapist

Beni-Suef University

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