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Approved for marketingNCT02883309PTH-CKD0113Updated Sep 30, 2016

Efficacy of an Intradialysis Combined Training Program on Disability Level and Physical Performance.

An expanded access record providing intradialytic physical training program in Chronic Renal Failure, sponsored by Universidad Austral de Chile. Approved for marketing. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-09-30.

Sponsored by Universidad Austral de Chile · Expanded access

Study type
Expanded access
Ages
50 Years to 80 Years
Sex
All
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Study summary

The patient subjected to hemodialysis has a low physical capacity due to being advanced in years and the complexity of the process, which is encouraged by family members and caregivers who lead them to a total dependence. The Intradialytic physical exercise is presented as an alternative to counteract this functional deterioration of patients with terminal chronic kidney failure.

Read the detailed description

Objective To evaluate the impact of the intradialytic physical training program on the level of disability and physical performance in patients subjected to hemodialysis.

Materials and methods 18 patients subjected to hemodialysis, whose ages ranged from 54 to 84 (10 women) were included in the study. Nine of these patients participated in a combined training program, which lasted 12 weeks, the training sessions were carried out within each dialysis session, the working session involved a warm-up period, aerobic exercise with pedals, or strength exercises based on free-weight depending on the training stage. The Borg scale and the heart rate reserve were used to control the training intensity. The disability level was evaluated at the beginning and end of the study through the World Health Organization Disability Assessment Schedule II, the six minutes walk test (6MWT), quadriceps strength, Kt/V, serum levels of potassium and creatinine.

Outcomes One subject belonging to the experimental group did not complete the training due to problems in the venous access during the 1st month of training. 8 patients in to the experimental group showed significant improvements in the 6MWT, quadriceps strength and decrease in the level of disability. No changes were observed in the control group. No significant changes were found in the serum levels of potassium and creatine.

Conclusions An Intradialytic physical training program achieved a substantial decrease in the level of disability, and an improvement of aerobic capacity and muscle strength. The study was funded by the extension office of the Austral University of Chile.

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Conditions studied

  • Chronic Renal Failure

Keywords

  • Hemodialysis
  • Skeletal muscle
  • Exercise
  • Rehabilitation
  • Disability Evaluation
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In context

Kidney Failure, Chronic

2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.

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Lead sponsor

Universidad Austral de Chile is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients which are subject to process of hemodialysis via arteriovenous fistula in dialysis unit Valdivia.
  • Which are between 60-80 years.
  • Therapy Dialysis for more than 3 months period.
  • Submit 24 or more points on the Mini-mental state test.

Exclusion criteria

Exclusion Criteria:

  • Inability to understand orders.
  • Dyspnea at rest.
  • Hospitalized one month before surgery.
  • Diseases Cerebrovascular transient ischemic attacks.
  • Lower limb amputation (ankle presence) that this orthopedic prosthesis.
  • Syndrome Acute coronary.
  • Congestive heart failure or severe pneumonia.
  • Patients with uncontrolled diabetes pharmacologically or are not within the appropriate standards of glucose for training.
  • Patients with uncontrolled hypertension pharmacologically or are not within the proper blood pressure standards for training.
  • Persistent Hyperkalemia .
  • Angina at rest.
  • Lung-disease which results in adverse effects.
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Access details

Study type
Expanded access

Available treatment

  • Otherintradialytic physical training program

    Nine patients participated in the experimental group in a combined training program, which lasted 12 weeks with a frequency of 3 times a week, the training sessions were carried out within each dialysis session during the first 2 hours of the dialysis treatment, the working session involved a warm up period, aerobic exercise with pedals, or strength exercises based on free weight depending on the training stage. The Borg scale and the heart rate reserve were used to control the training intensity. The disability level was evaluated at the beginning and the end of the study through the World Health Organization Disability Assessment Schedule II, the aerobic capacity was evaluated through the six minute walk and the limbs strength was evaluated through a dynamometer.

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Where to request access

No study locations are listed for this record.

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References and documents

Publications

  • Marriott HE, Lamb KL. The use of ratings of perceived exertion for regulating exercise levels in rowing ergometry. Eur J Appl Physiol Occup Physiol. 1996;72(3):267-71. doi: 10.1007/BF00838650. PubMed 8820897 ↗
  • Johansen KL, Shubert T, Doyle J, Soher B, Sakkas GK, Kent-Braun JA. Muscle atrophy in patients receiving hemodialysis: effects on muscle strength, muscle quality, and physical function. Kidney Int. 2003 Jan;63(1):291-7. doi: 10.1046/j.1523-1755.2003.00704.x. PubMed 12472795 ↗
  • Kurella Tamura M, Covinsky KE, Chertow GM, Yaffe K, Landefeld CS, McCulloch CE. Functional status of elderly adults before and after initiation of dialysis. N Engl J Med. 2009 Oct 15;361(16):1539-47. doi: 10.1056/NEJMoa0904655. PubMed 19828531 ↗
  • Johansen KL. Physical functioning and exercise capacity in patients on dialysis. Adv Ren Replace Ther. 1999 Apr;6(2):141-8. doi: 10.1016/s1073-4449(99)70032-4. PubMed 10230881 ↗
  • de Lima MC, Cicotoste Cde L, Cardoso Kda S, Forgiarini LA Jr, Monteiro MB, Dias AS. Effect of exercise performed during hemodialysis: strength versus aerobic. Ren Fail. 2013;35(5):697-704. doi: 10.3109/0886022X.2013.780977. Epub 2013 Apr 8. PubMed 23560491 ↗
  • Ribeiro R, Coutinho GL, Iuras A, Barbosa AM, Souza JA, Diniz DP, Schor N. Effect of resistance exercise intradialytic in renal patients chronic in hemodialysis. J Bras Nefrol. 2013 Jan-Mar;35(1):13-9. doi: 10.5935/01012800.20130003. English, Portuguese. PubMed 23598747 ↗
  • Giannaki CD, Stefanidis I, Karatzaferi C, Liakos N, Roka V, Ntente I, Sakkas GK. The effect of prolonged intradialytic exercise in hemodialysis efficiency indices. ASAIO J. 2011 May-Jun;57(3):213-8. doi: 10.1097/MAT.0b013e318215dc9e. PubMed 21412149 ↗
  • KARVONEN MJ, KENTALA E, MUSTALA O. The effects of training on heart rate; a longitudinal study. Ann Med Exp Biol Fenn. 1957;35(3):307-15. No abstract available. PubMed 13470504 ↗
  • American College of Sports Medicine Position Stand. The recommended quantity and quality of exercise for developing and maintaining cardiorespiratory and muscular fitness, and flexibility in healthy adults. Med Sci Sports Exerc. 1998 Jun;30(6):975-91. doi: 10.1097/00005768-199806000-00032. PubMed 9624661 ↗
  • Stoudemire NM, Wideman L, Pass KA, McGinnes CL, Gaesser GA, Weltman A. The validity of regulating blood lactate concentration during running by ratings of perceived exertion. Med Sci Sports Exerc. 1996 Apr;28(4):490-5. doi: 10.1097/00005768-199604000-00014. PubMed 8778555 ↗
  • Mercer TH, Naish PF, Gleeson NP, Wilcock JE, Crawford C. Development of a walking test for the assessment of functional capacity in non-anaemic maintenance dialysis patients. Nephrol Dial Transplant. 1998 Aug;13(8):2023-6. doi: 10.1093/ndt/13.8.2023. PubMed 9719158 ↗
  • ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. PubMed 12091180 ↗
  • DePaul V, Moreland J, Eager T, Clase CM. The effectiveness of aerobic and muscle strength training in patients receiving hemodialysis and EPO: a randomized controlled trial. Am J Kidney Dis. 2002 Dec;40(6):1219-29. doi: 10.1053/ajkd.2002.36887. PubMed 12460041 ↗
  • Headley S, Germain M, Mailloux P, Mulhern J, Ashworth B, Burris J, Brewer B, Nindl BC, Coughlin M, Welles R, Jones M. Resistance training improves strength and functional measures in patients with end-stage renal disease. Am J Kidney Dis. 2002 Aug;40(2):355-64. doi: 10.1053/ajkd.2002.34520. PubMed 12148109 ↗
  • Parsons TL, Toffelmire EB, King-VanVlack CE. Exercise training during hemodialysis improves dialysis efficacy and physical performance. Arch Phys Med Rehabil. 2006 May;87(5):680-7. doi: 10.1016/j.apmr.2005.12.044. PubMed 16635631 ↗
  • Redelmeier DA, Bayoumi AM, Goldstein RS, Guyatt GH. Interpreting small differences in functional status: the Six Minute Walk test in chronic lung disease patients. Am J Respir Crit Care Med. 1997 Apr;155(4):1278-82. doi: 10.1164/ajrccm.155.4.9105067. PubMed 9105067 ↗
  • Posl M, Cieza A, Stucki G. Psychometric properties of the WHODASII in rehabilitation patients. Qual Life Res. 2007 Nov;16(9):1521-31. doi: 10.1007/s11136-007-9259-4. Epub 2007 Sep 9. PubMed 17828578 ↗
  • Garin O, Ayuso-Mateos JL, Almansa J, Nieto M, Chatterji S, Vilagut G, Alonso J, Cieza A, Svetskova O, Burger H, Racca V, Francescutti C, Vieta E, Kostanjsek N, Raggi A, Leonardi M, Ferrer M; MHADIE consortium. Validation of the "World Health Organization Disability Assessment Schedule, WHODAS-2" in patients with chronic diseases. Health Qual Life Outcomes. 2010 May 19;8:51. doi: 10.1186/1477-7525-8-51. PubMed 20482853 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02883309
Lead sponsor
Universidad Austral de Chile
Collaborators
Nephrocare Portugal
Responsible party
Sponsor
First posted
Aug 30, 2016
Start date
Nov 2013
Primary completion
Jan 2014
Completion
Mar 2014
Last update
Sep 30, 2016

Study contacts

Paula I Moscoso, Mph PTh
study chair · Universidad Austral de Chile
Roberto G Mancilla, Student
principal investigator · Universidad Austral de Chile
Cesar E Gonzalez, Student
principal investigator · Universidad Austral de Chile
Manuel Monrroy, Msc(c) PTh
study director · Universidad Austral de Chile
Lizzy Orellana, MD
study director · Universidad Austral de Chile
View the source record on ClinicalTrials.gov ↗

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