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

NCT04916743 | Completed DMC

• 1 other identifier: PA21HD-2-04
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Kidney Diseases; End Stage Renal Disease; Hemodialysis

Keywords

Mortality; Mortality Rate; Survival; Cardiovascular Disease; Osteoporosis; Bone Mineral Disorders; Exercise during dialysis

Outcome Measures

Primary Outcomes (3)

• Rate of changes of Calcium for 6 months

  Pre_test and every 3 months for 6 months

• Rate of changes of Phosphorus for 6 months

  Pre_test and every 3 months for 6 months

• Rate of changes of Parathyroid Hormones for 6 months

  Pre_test and every 3 months for 6 months

Secondary Outcomes (2)

• Rate of changes of Calcium-Phosphorous product for 6 months

  Pre_test and every 3 months for 6 months

• Rate of changes of Alkaline Phosphatase for 6 months

  Pre_test and every 3 months for 6 months

Study Arms (2)

Exercise group

EXPERIMENTAL

The patients will participate in intradialytic exercise 3 times a week for 24 weeks.

Other: Intradialytic exercise group

Control group

NO INTERVENTION

The patients will receive regular care and treatment in every dialysis sessions without any intradialytic exercise.

Interventions

Intradialytic exercise group OTHER

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.

Exercise group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dialysis history ≥ 1 year
• Without myocardial infarction within past 3 months
• Regular dialysis 3 times a week
• Ability to consent
• Doctor's consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pardis Specialized Wellness Institute: lead

Study Sites (2)

Abolfazl medical center

Isfahan, 813991447, Iran

Location

Pardis specialized wellness institute

Isfahan, Iran

Location

Related Publications (19)

• 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.

  PMID: 27399824 BACKGROUND

• 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.

  PMID: 15806502 BACKGROUND

• 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.

  PMID: 27318109 BACKGROUND

• 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.

  PMID: 16253734 BACKGROUND

• 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.

  PMID: 30670499 BACKGROUND

• 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.

  PMID: 18305386 BACKGROUND

• 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.

  PMID: 14978180 BACKGROUND

• 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.

  PMID: 20383863 BACKGROUND

• 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.

  PMID: 25118037 BACKGROUND

• 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.

  PMID: 30463499 BACKGROUND

• 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.

  PMID: 25920921 BACKGROUND

• 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.

  PMID: 29707916 BACKGROUND

• 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.

  PMID: 18514987 BACKGROUND

• 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.

  PMID: 16820797 BACKGROUND

• 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.

  PMID: 15284307 BACKGROUND

• 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.

  PMID: 31454822 BACKGROUND

• 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.

  PMID: 31591041 BACKGROUND

• 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.

  PMID: 32751307 BACKGROUND

• 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.

  PMID: 37730530 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Cardiovascular Diseases; Osteoporosis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mohammad Ali Tabibi, Dr

  Pardis Specialized Wellness Institute

  PRINCIPAL INVESTIGATOR

• Mohammad Ali Tabibi, Dr

  Pardis Specialized Wellness Institute

  STUDY DIRECTOR

• Shahrzad Amirian Farsani

  Pardis Specialized Wellness Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The lab tech will be blind to whether the sample under evaluation belongs to the intervention group or the control group. Outcome adjudicators, and data analysts will be kept blinded to the allocation. Moreover, all investigators, staff, and participants will be kept masked to outcome measurements and trial results.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocate to intervention group or control group and will be examined in the same way.

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 8, 2021
• Study Start: July 30, 2021
• Primary Completion: January 29, 2022
• Study Completion: January 29, 2022
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available after the paper is published. No end date.
• Access Criteria: The IPD will be available only for our colleagues in Global Renal Exercise (GREX) as long as they have acceptable reasons for requiring the data.

Locations

IR (2)