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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:
Importance of this research:
Usefulness of this research to the UAE
Each patient will be asked to follow an Intradialytic aerobic low intensity exercise program of 45 minutes per each HD session throughout the 6-month study duration. The exercise will be tailored to each HD patient's ability (measured by VO2Max), supervised by the hospital physiotherapist and the research team. Continuous support and encouragement to the patients will be provided to assure they complete the 45 minutes of exercise on each HD session. Additionally, patients will be educated on the health benefits of exercise and how to integrate safe exercise into their daily life (by the research assistants).
Research assistants will be trained by the principal investigator (PI) on the study instruments and data collection methods. These assistants will administer 4 questionnaires (5 minutes each) for each HD patient separately and will collect data from the medical chart of each patient. The assessment will take place during the HD session.
The research assistants will also collect from the patient's file blood test results on a monthly basis (relevant to the study mentioned in table1); additional needed parameters will be analysed from the same blood sample that the hospital already collect for the patients monitoring, and will be analysed by the hospital for a fee from the research fund. For the β-aminoisobutyric acid (BAIBA) tests - cardiometabolic marker, 5 ML of the blood sample from each patient will be transported to a specialized lab for analysis.
All of the parameters, except the demographics (collected only at t0), will be collected and monitored at 3 time points: Baseline (t0), post-intervention (t1) and follow up (t2).
Assessment tools include
All questionnaires that are originally not Arabic, will be translated to Arabic (local language), prior to study by 2 translators whose first language is Arabic. Next step, each questionnaire will be translated back to English by a dietitian whose first language is English and who also knows Arabic. All questionnaires will be validated by running them on 10 patients and accordingly modifying their feasibility to the Emirates HD patient's culture, language level and comprehension status.
The physiotherapist and the research assistants will be responsible for training the patients on the exercise program and recording the intensity, duration, and modality of the exercise for each patient as well as patient's complaints and reasons for drop out, if any. The intervention will be given within the HD session: no extra time required beyond the time of HD. During the intervention, patient will be at all times under direct supervision of the physiotherapist and medical team; in case of any discomfort, the intervention will be immediately stopped.
Sample size was chosen based on convenient sampling. Patients of the HD unit who received clearance from the medical team, met the inclusion criteria and consented, were included in the study.
Data will be analyzed through Scientific Package for Social Sciences version 18. Descriptive statistics will be used to analyze the data. Correlations will be conducted through ANOVA. Effect of the study will be analyzed by paired t test on continuous data and Chi-square on categorical data
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Behavior questionnaire | questionnaire | at baseline, end of 6 month intervention, and at 1 year post intervention |
| Quality of Life | EQ-5D-5L questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| mirey Karavetian, PhD | Zayed University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AL Qassimi Hospital | Sharjah city | 3500 | United Arab Emirates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24279747 | Background | 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. | |
| 25504020 |
| Label | URL |
|---|---|
| McArdle, W.D., Katch, F.L. \& Katch, V. Exercise Physiology: Nutrition, Energy and Human Performance Hardcover - 1 Nov 2009. | View source |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| at baseline, end of 6 month intervention, and at 1 year |
| Malnutrition- Inflammation Syndrome | questionnaire | at baseline, end of 6 month intervention, and at 1 year post intervention |
| Exercise Fitness Level | assessed through both the BORG scale (exertion level measurement) and heart rate (pulse per minute) | Week #1,9,14,18,22,27,31 |
| Serum Phosphorous (mmol/L) | Blood test | Baseline (average of the past 6 months), Week #9,14,18,22,27,31, and at 1 year post intervention |
| β-aminoisobutyric acid (μM) | Blood test | at baseline and at post 6 month intervention |
| 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. |
| 24913219 | 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. |
| 24044062 | 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. |
| 25117942 | 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. |
| 15069177 | 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. |
| 10109801 | 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. |
| Borg Rate of Perceived Exertion scale (1998). Perceive Exertion (Borg Rating of Perceived Exertion Scale). Center for Disease Control and Prevention | View source |