The Effect of Exercise on Blood Parameters Related to Dialysis Patients' Survival

Chronic Kidney Diseases Clinical Trial

Official title:

The Effect of Intradialytic Exercise on Calcium, Phosphorus and Parathyroid Hormone: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04916743
• Other study ID #: PA21HD-2-04
• Status: Completed
• Phase: N/A
• Start date: July 30, 2021
• Est. completion date: January 29, 2022

Study information

• Verified date: March 2022
• Source: Pardis Specialized Wellness Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Dialysis patients suffer from a number of problems, one of which is reduced ability, decreased functional capacity, and consequently reduced physical capability. Forced inactivity due to immobility in dialysis sessions and the need to rest and relieve fatigue for a few hours after each session cause patients to become more inactive day by day, and according to various studies, inactivity in these patients along with reduced physical capabilities increase the risk of cardiovascular disease (CVD), which is a risk factor for mortality in these patients. 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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• End Stage Renal Disease
• Hemodialysis
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Abolfazl medical center	Isfahan
Iran, Islamic Republic of	Pardis specialized wellness institute	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Pardis Specialized Wellness Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (18)

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

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. — View Citation

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. Review. — View Citation

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

Outcome

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