The Effect of Exercise on Dialysis Patients' Survival

NCT04898608 | Completed DMC

• 1 other identifier: PA20HD-2-01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to check if patients' exercise during their dialysis sessions can prevent their early deaths.

Conditions

Kidney Disease, Chronic; End Stage Renal Disease; Hemodialysis

Keywords

mortality; exercise during dialysis; physical function; sarcopenia; hematological parameters

Outcome Measures

Primary Outcomes (1)

• 1-year Survival of dialysis patients

  Mortality data is gathered using form "CMS-2746" which is specifically for dialysis patients.

  Follow-up phase (1- year)

Secondary Outcomes (9)

• Rate of changes of Albumin for 6 months

  Pre_test and every 3 months for 6 months

• Rate of changes of Hemoglobin for 6 months

  Pre_test and every 3 months for 6 months

• Rate of changes of Hematocrit for 6 months

  Pre_test and every 3 months for 6 months

• Rate of changes of Red Blood Cells for 6 months

  Pre_test and every 3 months for 6 months

• Rate of changes of Calcium 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

Control group

NO INTERVENTION

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

Interventions

Intradialytic Exercise 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 1RM 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 (23)

• Xiong J, Wang M, Zhang Y, Nie L, He T, Wang Y, Huang Y, Feng B, Zhang J, Zhao J. Association of Geriatric Nutritional Risk Index with Mortality in Hemodialysis Patients: A Meta-Analysis of Cohort Studies. Kidney Blood Press Res. 2018;43(6):1878-1889. doi: 10.1159/000495999. Epub 2018 Dec 14.

  PMID: 30566933 BACKGROUND

• Tabibi MA, Ahmadi E, Nasrin S. POS-621 The effect of concurent exercise during dialysis on hemoglobin,red blood cells and hematocrit in hemodialysis patients. Kidney International Reports. 2021; 6(4): 270-271. doi: 10.1016/j.ekir.2021.03.650

  BACKGROUND

• Shimoda T, Matsuzawa R, Yoneki K, Harada M, Watanabe T, Matsumoto M, Yoshida A, Takeuchi Y, Matsunaga A. Changes in physical activity and risk of all-cause mortality in patients on maintence hemodialysis: a retrospective cohort study. BMC Nephrol. 2017 May 8;18(1):154. doi: 10.1186/s12882-017-0569-7.

  PMID: 28482880 BACKGROUND

• Bakaloudi DR, Siargkas A, Poulia KA, Dounousi E, Chourdakis M. The Effect of Exercise on Nutritional Status and Body Composition in Hemodialysis: A Systematic Review. Nutrients. 2020 Oct 8;12(10):3071. doi: 10.3390/nu12103071.

  PMID: 33050111 BACKGROUND

• 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

• Scapini KB, Bohlke M, Moraes OA, Rodrigues CG, Inacio JF, Sbruzzi G, Leguisamo CP, Sanches IC, Tourinho Filho H, Irigoyen MC. Combined training is the most effective training modality to improve aerobic capacity and blood pressure control in people requiring haemodialysis for end-stage renal disease: systematic review and network meta-analysis. J Physiother. 2019 Jan;65(1):4-15. doi: 10.1016/j.jphys.2018.11.008. Epub 2018 Dec 21.

  PMID: 30581137 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

• 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

• Zhang F, Zhou W, Sun Q, Zhai Y, Zhang Y, Su H, Wang Z. Effects of intradialytic resistance exercises on physical performance, nutrient intake and quality of life among haemodialysis people: A systematic review and meta-analysis. Nurs Open. 2021 Mar;8(2):529-538. doi: 10.1002/nop2.274. Epub 2019 Sep 30.

  PMID: 33570280 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

• 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

• Pifer TB, McCullough KP, Port FK, Goodkin DA, Maroni BJ, Held PJ, Young EW. Mortality risk in hemodialysis patients and changes in nutritional indicators: DOPPS. Kidney Int. 2002 Dec;62(6):2238-45. doi: 10.1046/j.1523-1755.2002.00658.x.

  PMID: 12427151 BACKGROUND

• Avram MM, Blaustein D, Fein PA, Goel N, Chattopadhyay J, Mittman N. Hemoglobin predicts long-term survival in dialysis patients: a 15-year single-center longitudinal study and a correlation trend between prealbumin and hemoglobin. Kidney Int Suppl. 2003 Nov;(87):S6-11. doi: 10.1046/j.1523-1755.64.s87.3.x.

  PMID: 14531767 BACKGROUND

• Foley RN, Parfrey PS, Morgan J, Barre PE, Campbell P, Cartier P, Coyle D, Fine A, Handa P, Kingma I, Lau CY, Levin A, Mendelssohn D, Muirhead N, Murphy B, Plante RK, Posen G, Wells GA. Effect of hemoglobin levels in hemodialysis patients with asymptomatic cardiomyopathy. Kidney Int. 2000 Sep;58(3):1325-35. doi: 10.1046/j.1523-1755.2000.00289.x.

  PMID: 10972697 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

• 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

• Kohl Lde M, Signori LU, Ribeiro RA, Silva AM, Moreira PR, Dipp T, Sbruzzi G, Lukrafka JL, Plentz RD. Prognostic value of the six-minute walk test in end-stage renal disease life expectancy: a prospective cohort study. Clinics (Sao Paulo). 2012;67(6):581-6. doi: 10.6061/clinics/2012(06)06.

  PMID: 22760895 BACKGROUND

• Evangelidis N, Tong A, Manns B, Hemmelgarn B, Wheeler DC, Tugwell P, Crowe S, Harris T, Van Biesen W, Winkelmayer WC, Sautenet B, O'Donoghue D, Tam-Tham H, Youssouf S, Mandayam S, Ju A, Hawley C, Pollock C, Harris DC, Johnson DW, Rifkin DE, Tentori F, Agar J, Polkinghorne KR, Gallagher M, Kerr PG, McDonald SP, Howard K, Howell M, Craig JC; Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Initiative. Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey. Am J Kidney Dis. 2017 Oct;70(4):464-475. doi: 10.1053/j.ajkd.2016.11.029. Epub 2017 Feb 24.

  PMID: 28238554 BACKGROUND

• Chantrel F, de Cornelissen F, Deloumeaux J, Lange C, Lassalle M; registre REIN. [Survival and mortality in ESRD patients]. Nephrol Ther. 2013 Sep;9 Suppl 1:S127-37. doi: 10.1016/S1769-7255(13)70042-7. French.

  PMID: 24119578 BACKGROUND

• Tabibi MA, Cheema B, Salimian N, Correa HL, Ahmadi S. The effect of intradialytic exercise on dialysis patient survival: a randomized controlled trial. BMC Nephrol. 2023 Apr 17;24(1):100. doi: 10.1186/s12882-023-03158-6.

  PMID: 37069527 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Sarcopenia

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; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Mohammad Ali Tabibi, Dr

  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. A research project collaborator who is not informed about grouping of participants will obtain outcome measurements of the functional test. 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: May 18, 2021
• First Posted: May 24, 2021
• Study Start: January 25, 2020
• Primary Completion: August 9, 2021
• Study Completion: August 9, 2021
• Last Updated: March 28, 2023

Record last verified: 2021-05

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 GREX as long as they have acceptable reasons for requiring the data.

Locations

IR (2)