Chronic Kidney Diseases Clinical Trial
Official title:
The Effect of Intradialytic Exercise on Calcium, Phosphorus and Parathyroid Hormone: A Randomized Controlled Trial
Verified date | March 2022 |
Source | Pardis Specialized Wellness Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to check if patients' exercise during their dialysis sessions can improve the blood parameters which affect the heart disease and osteoporosis, so that we can help patients live longer.
Status | Completed |
Enrollment | 44 |
Est. completion date | January 29, 2022 |
Est. primary completion date | January 29, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Dialysis history = 1 year - Without myocardial infarction within past 3 months - Regular dialysis 3 times a week - Ability to consent - Doctor's consent Exclusion Criteria: - Unstable cardiac status (angina, decompensated congestive heart failure, severe arteriovenous stenosis, uncontrolled arrhythmias, etc.) - 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) |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Abolfazl medical center | Isfahan | |
Iran, Islamic Republic of | Pardis specialized wellness institute | Isfahan |
Lead Sponsor | Collaborator |
---|---|
Pardis Specialized Wellness Institute |
Iran, Islamic Republic of,
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. Review. — View Citation
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Fernández-Martín JL, Martínez-Camblor P, Dionisi MP, Floege J, Ketteler M, London G, Locatelli F, Gorriz JL, Rutkowski B, Ferreira A, Bos WJ, Covic A, Rodríguez-García M, Sánchez JE, Rodríguez-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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. Epub 2006 Jul 5. — View Citation
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). pii: E5388. doi: 10.3390/ijms21155388. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Tüysüz 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. — View Citation
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. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of changes of Calcium for 6 months | Pre_test and every 3 months for 6 months | ||
Primary | Rate of changes of Phosphorus for 6 months | Pre_test and every 3 months for 6 months | ||
Primary | Rate of changes of Parathyroid Hormones for 6 months | Pre_test and every 3 months for 6 months | ||
Secondary | Rate of changes of Calcium-Phosphorous product for 6 months | Pre_test and every 3 months for 6 months | ||
Secondary | Rate of changes of Alkaline Phosphatase for 6 months | Pre_test and every 3 months for 6 months |
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