Effect of Intradialytic Exercise In The United Arab Emirates
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|ClinicalTrials.gov Identifier: NCT03131804|
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : June 16, 2017
Hemodialysis (HD) patients have decreased physical functioning, diminished muscle mass and altered muscle quality thus the increased mortality rate compared to their age-matched population. Risk factors include their sedentary lifestyle and altered nutritional status ; the sedentary lifestyle or the lack of exercise is known to be a risk factor for cardiovascular complications  and contributes to worsen protein energy wasting (PEW), which is described as the loss of body protein mass and fuel reserves . Therefore the health of the HD patients and consequently their quality of life (QOL) is deteriorated.
Studies have shown that aerobic exercise during HD improves aerobic capacity, blood pressure, heart rate, muscular strength, dialysis efficacy and quality of life; however, such studies were not done on the United Arab Emirates (UAE) HD patients and there is no protocol for implementing exercise in the UAE HD units [3-4]
Hypothesis: Intradialytic aerobic exercise will result in significantly improved clinical, cardio-metabolic and quality of life outcomes and reduced cost of care.
Primary objective of the study:
- To investigate whether the intradialytic exercise (IDE) within the routine practice of hemodialysis in the UAE will improve adequacy of dialysis.
Secondary objectives of the study:
- To study the effect of clinical and cardio-metabolic outcomes of the HD patients.
- Explore whether the trial would improve the cost effectiveness of this patient population's health care
- Define the nature of the IDE programs (intensity, duration, modality), and feasibility of its application in routine setting.
Importance of this research:
- Pioneering research in the Middle East and Gulf Cooperation Council (GCC) countries where the effect of intradialytic exercise will be studied for the first time on Arab population.
- It will contribute in identifying the exact strategies to integrate within the hemodialysis unit to improve clinical and cardio-metabolic outcomes, quality of life and healthcare cost.
Usefulness of this research to the UAE
- It will improve the health care cost and reduce cost wastage in the UAE (lean management).
- It will put UAE on the pedestal in front of other countries in integrating innovative methods for a better care of hemodialysis patients.
|Condition or disease||Intervention/treatment||Phase|
|Exercise Dialysis||Other: Intradialytic aerobic low intensity exercise||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Effect of Intradialytic Exercise Among Hemodialysis Patients in the United Arab Emirates on Cardio-Metabolic Markers, Dialysis Adequacy, Quality of Life and Cost Effectiveness|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||October 1, 2017|
|Estimated Study Completion Date :||April 1, 2018|
Experimental: Interventional Participants
Patients will represent their own controls (pre and post intervention), in the HD unit of Al Qassimi Hospital, Sharjah, United Arab Emirates.
Other: Intradialytic aerobic low intensity exercise
Intradialytic aerobic low intensity exercise program of 45 minutes per each hemodialysis session throughout the 6-month study duration
- Urea Reduction Ratio (URR) (mmol/L) [ Time Frame: Baseline (average of the last 6 months), Week #9,14,18,22,27,31, and at 1 year post intervention ]it is blood urea nitrogen taken pre and post a dialysis session
- Exercise Behavior questionnaire [ Time Frame: at baseline, end of 6 month intervention, and at 1 year post intervention ]questionnaire
- Quality of Life [ Time Frame: at baseline, end of 6 month intervention, and at 1 year ]EQ-5D-5L questionnaire
- Malnutrition- Inflammation Syndrome [ Time Frame: at baseline, end of 6 month intervention, and at 1 year post intervention ]questionnaire
- Exercise Fitness Level [ Time Frame: Week #1,9,14,18,22,27,31 ]assessed through both the BORG scale (exertion level measurement) and heart rate (pulse per minute)
- Serum Phosphorous (mmol/L) [ Time Frame: Baseline (average of the past 6 months), Week #9,14,18,22,27,31, and at 1 year post intervention ]Blood test
- β-aminoisobutyric acid (μM) [ Time Frame: at baseline and at post 6 month intervention ]Blood test
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131804
|Contact: Mirey Karavetian, PhD||+971562446865||Mirey.Karavetian@zu.ac.ae|
|United Arab Emirates|
|AL Qassimi Hospital||Recruiting|
|Sharjah, United Arab Emirates, 3500|
|Contact: Consultant Nephrologist +971509693848 Harithmuthana@yahoo.com|
|Principal Investigator:||mirey Karavetian, PhD||Zayed University|