Effect of Intradialytic Exercise In The United Arab Emirates

NCT03131804 | Completed

• 1 other identifier: 9637
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise; Dialysis

Keywords

Aerobic; Intradialytic; Cardio-metabolic markers; Dialysis Adequacy; Quality of Life; Cost Effectiveness

Outcome Measures

Primary Outcomes (1)

• Urea Reduction Ratio (URR) (mmol/L)

  it is blood urea nitrogen taken pre and post a dialysis session

  Baseline (average of the last 6 months), Week #9,14,18,22,27,31, and at 1 year post intervention

Secondary Outcomes (6)

• Exercise Behavior questionnaire

  at baseline, end of 6 month intervention, and at 1 year post intervention

• Quality of Life

  at baseline, end of 6 month intervention, and at 1 year

• Malnutrition- Inflammation Syndrome

  at baseline, end of 6 month intervention, and at 1 year post intervention

• Exercise Fitness Level

  Week #1,9,14,18,22,27,31

• Serum Phosphorous (mmol/L)

  Baseline (average of the past 6 months), Week #9,14,18,22,27,31, and at 1 year post intervention

Study Arms (1)

Interventional Participants

EXPERIMENTAL

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

Interventions

Intradialytic aerobic low intensity exercise OTHER

Intradialytic aerobic low intensity exercise program of 45 minutes per each hemodialysis session throughout the 6-month study duration

Interventional Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zayed University: lead

Study Sites (1)

AL Qassimi Hospital

Sharjah city, 3500, United Arab Emirates

Location

Related Publications (7)

• Magnard J, Deschamps T, Cornu C, Paris A, Hristea D. Effects of a six-month intradialytic physical ACTIvity program and adequate NUTritional support on protein-energy wasting, physical functioning and quality of life in chronic hemodialysis patients: ACTINUT study protocol for a randomised controlled trial. BMC Nephrol. 2013 Nov 26;14:259. doi: 10.1186/1471-2369-14-259.

  PMID: 24279747 BACKGROUND

• Sheng K, Zhang P, Chen L, Cheng J, Wu C, Chen J. Intradialytic exercise in hemodialysis patients: a systematic review and meta-analysis. Am J Nephrol. 2014;40(5):478-90. doi: 10.1159/000368722. Epub 2014 Dec 9.

  PMID: 25504020 BACKGROUND

• Heiwe S, Jacobson SH. Exercise training in adults with CKD: a systematic review and meta-analysis. Am J Kidney Dis. 2014 Sep;64(3):383-93. doi: 10.1053/j.ajkd.2014.03.020. Epub 2014 Jun 7.

  PMID: 24913219 BACKGROUND

• Mohseni R, Emami Zeydi A, Ilali E, Adib-Hajbaghery M, Makhlough A. The effect of intradialytic aerobic exercise on dialysis efficacy in hemodialysis patients: a randomized controlled trial. Oman Med J. 2013 Sep;28(5):345-9. doi: 10.5001/omj.2013.99.

  PMID: 24044062 BACKGROUND

• Fiaccadori E, Sabatino A, Schito F, Angella F, Malagoli M, Tucci M, Cupisti A, Capitanini A, Regolisti G. Barriers to physical activity in chronic hemodialysis patients: a single-center pilot study in an Italian dialysis facility. Kidney Blood Press Res. 2014;39(2-3):169-75. doi: 10.1159/000355793. Epub 2014 Jul 29.

  PMID: 25117942 BACKGROUND

• Kalantar-Zadeh K, Kopple JD, Humphreys MH, Block G. Comparing outcome predictability of markers of malnutrition-inflammation complex syndrome in haemodialysis patients. Nephrol Dial Transplant. 2004 Jun;19(6):1507-19. doi: 10.1093/ndt/gfh143. Epub 2004 Apr 6.

  PMID: 15069177 BACKGROUND

• EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

  PMID: 10109801 BACKGROUND

Related Links

• McArdle, W.D., Katch, F.L. \& Katch, V. Exercise Physiology: Nutrition, Energy and Human Performance Hardcover - 1 Nov 2009.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• mirey Karavetian, PhD

  Zayed University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 27, 2017
• Study Start: March 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: April 1, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)