The Effect of Exercise on Blood Parameters Related to Dialysis Patients' Survival
NCT ID: NCT04916743
Last Updated: 2022-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
44 participants
INTERVENTIONAL
2021-07-30
2022-01-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Anabolic Steroids and Exercise in Hemodialysis Patients
NCT00250536
Study of 1.25 mmol/L Calcium Dialysate on Mineral Metabolism in Haemodialysis Patients.
NCT00744302
Sub-total Parathyroidectomy Reduces Vascular Calcification in Haemodialysis Patients
NCT01140490
The Effects of Isoflavones on Cardiovascular and Bone Metabolism Markers in Peritoneal Dialysis Patients
NCT03773029
Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients
NCT03937349
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
On the other hand, inactivity is an independent predictor of hospitalization and mortality in these patients.
The mortality rate of dialysis patients is much higher than that of healthy people, to the extent that it is reported to be about 10 to 30 times higher. The life expectancy of these patients is between 30 and 50 percent lower than that of people without the same age and sex. Dialysis patients suffer from many CVDs such as high blood pressure, vascular disease, congestive heart failure and arrhythmias. CVDs in patients are related to traditional risk factors such as diabetes, hypertension, sedentary lifestyle and non-traditional risk factors such as anemia, inflammation, abnormal calcium metabolism and phosphorus and oxidative stress. Studies have shown that high levels of calcium, phosphorus , calcium- phosphorus product and parathyroid hormone are associated with fatal and non-fatal cardiovascular events and all-cause mortality in dialysis patients.
One of the most common complications of chronic kidney disease is hypophosphatemia. Phosphate metabolism is regulated by the interaction of the kidneys, bones and intestines. This balance is impaired in kidney patients and the calcification process occurs through disturbances in the regulation of calcium, phosphate, and hyperparathyroidism. Hyperparathyroidism is considered as one of the aggravating causes of anemia as well as resistance to erythropoietin treatment in hemodialysis patients. Due to the effect of parathyroid hormone in the regulation of calcium and the anabolic and catabolic role of the bones, the regulation of this hormone is essential for all people, especially dialysis patients.
Human studies have shown that the regulation of parathyroid hormone and calcium and phosphorus metabolism are dependent on physical activity, and they have introduced exercise as an effective way to regulate this hormone. Considering the various effects of exercise on dialysis patients, a study has been designed to investigate the effect of concurrent exercise during dialysis on changes in calcium levels, phosphorus, calcium-phosphorus product, and parathyroid hormone.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exercise group
The patients will participate in intradialytic exercise 3 times a week for 24 weeks.
Intradialytic exercise group
Participants will do concurrent exercise (a combination of aerobic exercise and resistance training) for 30-60 minutes during the second hour of their routine hemodialysis sessions. To determine the intensity of the prescribed exercise, maximum heart rate is used for aerobic workout and 5 Repetitions Maximum (5RM) for resistance protocols. Exercises will be performed at a moderate exercise intensity (12-14 on the Borg RPE Scale). All protocols are tailor-made based on each individual's needs and physical abilities.
Control group
The patients will receive regular care and treatment in every dialysis sessions without any intradialytic exercise.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intradialytic exercise group
Participants will do concurrent exercise (a combination of aerobic exercise and resistance training) for 30-60 minutes during the second hour of their routine hemodialysis sessions. To determine the intensity of the prescribed exercise, maximum heart rate is used for aerobic workout and 5 Repetitions Maximum (5RM) for resistance protocols. Exercises will be performed at a moderate exercise intensity (12-14 on the Borg RPE Scale). All protocols are tailor-made based on each individual's needs and physical abilities.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Without myocardial infarction within past 3 months
* Regular dialysis 3 times a week
* Ability to consent
* Doctor's consent
Exclusion Criteria
* Active infection or acute medical illness
* Hemodynamic instability
* Labile glycemic control
* Unable to exercise (lower extremity amputation with no prosthesis)
* having severe musculoskeletal pain at rest or with minimal activity
* Unable to sit, stand or walk unassisted (walking device such as cane or walker allowed)
* Having shortness of breath at rest or with activities of daily living (NYHA Class IV)
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pardis Specialized Wellness Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mohammad Ali Tabibi, Dr
Role: PRINCIPAL_INVESTIGATOR
Pardis Specialized Wellness Institute
Mohammad Ali Tabibi, Dr
Role: STUDY_DIRECTOR
Pardis Specialized Wellness Institute
Shahrzad Amirian Farsani
Role: PRINCIPAL_INVESTIGATOR
Pardis Specialized Wellness Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Abolfazl medical center
Isfahan, , Iran
Pardis specialized wellness institute
Isfahan, , Iran
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Parker K. Intradialytic Exercise is Medicine for Hemodialysis Patients. Curr Sports Med Rep. 2016 Jul-Aug;15(4):269-75. doi: 10.1249/JSR.0000000000000280.
K/DOQI Workgroup. K/DOQI clinical practice guidelines for cardiovascular disease in dialysis patients. Am J Kidney Dis. 2005 Apr;45(4 Suppl 3):S1-153. No abstract available.
Milam RH. Exercise Guidelines for Chronic Kidney Disease Patients. J Ren Nutr. 2016 Jul;26(4):e23-5. doi: 10.1053/j.jrn.2016.03.001. No abstract available.
Noordzij M, Korevaar JC, Boeschoten EW, Dekker FW, Bos WJ, Krediet RT; Netherlands Cooperative Study on the Adequacy of Dialysis (NECOSAD) Study Group. The Kidney Disease Outcomes Quality Initiative (K/DOQI) Guideline for Bone Metabolism and Disease in CKD: association with mortality in dialysis patients. Am J Kidney Dis. 2005 Nov;46(5):925-32. doi: 10.1053/j.ajkd.2005.08.013.
Pu J, Jiang Z, Wu W, Li L, Zhang L, Li Y, Liu Q, Ou S. Efficacy and safety of intradialytic exercise in haemodialysis patients: a systematic review and meta-analysis. BMJ Open. 2019 Jan 21;9(1):e020633. doi: 10.1136/bmjopen-2017-020633.
Noordzij M, Korevaar JC, Dekker FW, Boeschoten EW, Bos WJ, Krediet RT, Bossuyt PM, Geskus RB; NECOSAD study group. Mineral metabolism and mortality in dialysis patients: a reassessment of the K/DOQI guideline. Blood Purif. 2008;26(3):231-7. doi: 10.1159/000118847. Epub 2008 Feb 28.
Stevens LA, Djurdjev O, Cardew S, Cameron EC, Levin A. Calcium, phosphate, and parathyroid hormone levels in combination and as a function of dialysis duration predict mortality: evidence for the complexity of the association between mineral metabolism and outcomes. J Am Soc Nephrol. 2004 Mar;15(3):770-9. doi: 10.1097/01.asn.0000113243.24155.2f.
Bohm CJ, Ho J, Duhamel TA. Regular physical activity and exercise therapy in end-stage renal disease: how should we move forward? J Nephrol. 2010 May-Jun;23(3):235-43.
Aucella F, Gesuete A, Battaglia Y. A "nephrological" approach to physical activity. Kidney Blood Press Res. 2014;39(2-3):189-96. doi: 10.1159/000355796. Epub 2014 Jul 29.
Tuysuz ME, Dedemoglu M. Calcium phosphate product level as a predictor for arteriovenous fistula re-operations in patients with chronic renal failure. Vascular. 2019 Jun;27(3):284-290. doi: 10.1177/1708538118814611. Epub 2018 Nov 21.
Fernandez-Martin JL, Martinez-Camblor P, Dionisi MP, Floege J, Ketteler M, London G, Locatelli F, Gorriz JL, Rutkowski B, Ferreira A, Bos WJ, Covic A, Rodriguez-Garcia M, Sanchez JE, Rodriguez-Puyol D, Cannata-Andia JB; COSMOS group. Improvement of mineral and bone metabolism markers is associated with better survival in haemodialysis patients: the COSMOS study. Nephrol Dial Transplant. 2015 Sep;30(9):1542-51. doi: 10.1093/ndt/gfv099. Epub 2015 Apr 28.
Fujii H. Association between Parathyroid Hormone and Cardiovascular Disease. Ther Apher Dial. 2018 Jun;22(3):236-241. doi: 10.1111/1744-9987.12679. Epub 2018 Apr 30.
Tentori F, Blayney MJ, Albert JM, Gillespie BW, Kerr PG, Bommer J, Young EW, Akizawa T, Akiba T, Pisoni RL, Robinson BM, Port FK. Mortality risk for dialysis patients with different levels of serum calcium, phosphorus, and PTH: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2008 Sep;52(3):519-30. doi: 10.1053/j.ajkd.2008.03.020. Epub 2008 Jun 2.
Kalantar-Zadeh K, Kuwae N, Regidor DL, Kovesdy CP, Kilpatrick RD, Shinaberger CS, McAllister CJ, Budoff MJ, Salusky IB, Kopple JD. Survival predictability of time-varying indicators of bone disease in maintenance hemodialysis patients. Kidney Int. 2006 Aug;70(4):771-80. doi: 10.1038/sj.ki.5001514. Epub 2006 Jul 5.
Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2.
Huang M, Lv A, Wang J, Xu N, Ma G, Zhai Z, Zhang B, Gao J, Ni C. Exercise Training and Outcomes in Hemodialysis Patients: Systematic Review and Meta-Analysis. Am J Nephrol. 2019;50(4):240-254. doi: 10.1159/000502447. Epub 2019 Aug 27.
Wilund K, Thompson S, Bennett PN. A Global Approach to Increasing Physical Activity and Exercise in Kidney Care: The International Society of Renal Nutrition and Metabolism Global Renal Exercise Group. J Ren Nutr. 2019 Nov;29(6):467-470. doi: 10.1053/j.jrn.2019.08.004. Epub 2019 Oct 4. No abstract available.
Lombardi G, Ziemann E, Banfi G, Corbetta S. Physical Activity-Dependent Regulation of Parathyroid Hormone and Calcium-Phosphorous Metabolism. Int J Mol Sci. 2020 Jul 29;21(15):5388. doi: 10.3390/ijms21155388.
Tabibi MA, Wilund KR, Salimian N, Nikbakht S, Soleymany M, Roshanaeian Z, Nazemi F, Ahmadi S. The effect of intradialytic exercise on calcium, phosphorus and parathyroid hormone: a randomized controlled trial. BMC Nephrol. 2023 Sep 20;24(1):276. doi: 10.1186/s12882-023-03327-7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PA21HD-2-04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.