The Effect of Exercise on Dialysis Patients' Survival

End Stage Renal Disease Clinical Trial

Official title:

The Effect of Intradialytic Exercise on Dialysis Patients' Survival: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04898608
• Other study ID #: PA20HD-2-01
• Status: Completed
• Phase: N/A
• Start date: January 25, 2020
• Est. completion date: August 9, 2021

Study information

• Verified date: May 2021
• 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 prevent their early deaths.

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, 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.

Studies have shown that exercise can produce many different effects in these patients. However, exercise interventions are often short-term, and even in long-term cases, the aim of studies is only to examine a number of hematological factors or factors such as functional capacity in these patients.

A study is currently being designed to directly evaluate the impact of exercise on patients' survival.

To test this hypothesis, patients do exercise for 6 months during dialysis. And then will be monitored for a year to determine patients' survival.

During 6 months of intervention, hematological parameters, nutrition index and functional capacity of patients are evaluated.

In the analyzes, the survival rate of patients in one year follow-up period is compared between patients who took part in intradialytic sessions (intervention group) and patients who did not do any physical activity during dialysis (control group). In addition, by analyzing the variables measured during the 6 months of the intervention, the effect of exercise on parameters relating to survival is evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 9, 2021
• Est. primary completion date: August 9, 2021
• 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

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

Intervention

Other:
• Intradialytic Exercise
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.

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 (22)

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. — View Citation

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. — View Citation

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. — 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. — View Citation

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. — View Citation

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. — View Citation

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. — 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. No abstract available. — View Citation

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. — 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. No abstract available. — 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. doi: 10.1053/j.ajkd.2005.08.013. — 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. — View Citation

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. — 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

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. — View Citation

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. — 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. doi: 10.1097/01.asn.0000113243.24155.2f. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of changes of Albumin for 6 months		Pre_test and every 3 months for 6 months
Secondary	Rate of changes of Hemoglobin for 6 months		Pre_test and every 3 months for 6 months
Secondary	Rate of changes of Hematocrit for 6 months		Pre_test and every 3 months for 6 months
Secondary	Rate of changes of Red Blood Cells for 6 months		Pre_test and every 3 months for 6 months
Secondary	Rate of changes of Calcium for 6 months		Pre_test and every 3 months for 6 months
Secondary	Rate of changes of Phosphorus for 6 months		Pre_test and every 3 months for 6 months
Secondary	Rate of changes of Parathyroid Hormone for 6 months		Pre_test and every 3 months for 6 months
Secondary	Changes of GNRI for 6 months	The Geriatric Nutritional Risk Index (GNRI) is a screening method that was primarily developed to identify older patients with malnutrition. It consists of serum albumin levels as well as body weight measurements. GNRI is associated with an increasing risk of long-term all-cause mortality in prevalent hemodialysis patients, even after adjusting for age and comorbidity	Pre_test and every 3 months for 6 months
Secondary	Changes of the meters walked during the 6MWT for 6 months	Six-minute walk test (6MWT) is a walking endurance assessment measured in meters of total distance completed over 6 minutes	Pre_test and every 3 months for 6 months