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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: mahmoud I mahmoud, lecturer
- Phone Number: 00201142998414
- Email: Mahmoud.ibrahim@pt.bsu.edu.eg
Study Contact Backup
- Name: eman M abdallah, master degree
- Phone Number: 00201000665383
- Email: emem43332@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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
|
|
Active Comparator: 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) |
|
No Intervention: control group c receive medical only
no exercise this group do assessment pre and post 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6 minute walk test
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: sherien H mehani, professor, Beni _suef
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AF in Hemodialysis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.