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Effect of Intradialytic Exercise In The United Arab Emirates

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ClinicalTrials.gov Identifier: NCT03131804
Recruitment Status : Completed
First Posted : April 27, 2017
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Mirey Karavetian, Zayed University

Brief Summary:

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 [1]; the sedentary lifestyle or the lack of exercise is known to be a risk factor for cardiovascular complications [2] and contributes to worsen protein energy wasting (PEW), which is described as the loss of body protein mass and fuel reserves [1]. 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)
Actual Enrollment : 41 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
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Exercise Behavior questionnaire [ Time Frame: at baseline, end of 6 month intervention, and at 1 year post intervention ]
    questionnaire

  2. Quality of Life [ Time Frame: at baseline, end of 6 month intervention, and at 1 year ]
    EQ-5D-5L questionnaire

  3. Malnutrition- Inflammation Syndrome [ Time Frame: at baseline, end of 6 month intervention, and at 1 year post intervention ]
    questionnaire

  4. 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)

  5. 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

  6. β-aminoisobutyric acid (μM) [ Time Frame: at baseline and at post 6 month intervention ]
    Blood test



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HD patients from the selected HD units in the UAE on HD 3 times a week
  • Stable on HD (free of life -threatening acute or chronic disease, with a life expectancy of > 6 months)
  • ≥ 3 months on HD
  • The gender being irrespective (age ≥ 18)
  • Not practicing any physical activity
  • With no recent hospitalization (in the last 3 months for ACUTE condition)
  • At their full capacity of cognitive, psychiatric and physical ability for self-care and communication
  • Capable to communicate either verbally or through writing
  • Fully aware of the proposed protocol of the study, and able to provide a consent form.
  • All selected patients should have received clearance from their nephrologist and cardiologist that they are eligible to start an exercise program

Exclusion Criteria:

  • Patients not meeting the inclusion criteria listed above
  • Patients not able to perform the exercise program
  • Patients who did not receive the clearance of the attending nephrologist of the unit to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131804


Locations
United Arab Emirates
AL Qassimi Hospital
Sharjah, United Arab Emirates, 3500
Sponsors and Collaborators
Zayed University
Investigators
Principal Investigator: mirey Karavetian, PhD Zayed University

Additional Information:
Publications:

Responsible Party: Mirey Karavetian, Assistant Professor, Zayed University
ClinicalTrials.gov Identifier: NCT03131804     History of Changes
Other Study ID Numbers: 9637
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mirey Karavetian, Zayed University:
Aerobic
Intradialytic
Cardio-metabolic markers
Dialysis Adequacy
Quality of Life
Cost Effectiveness