NCT02883309

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2013

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

2 months

First QC Date

August 25, 2016

Last Update Submit

September 28, 2016

Conditions

Chronic Renal Failure

Keywords

HemodialysisSkeletal muscleExerciseRehabilitationDisability Evaluation

Interventions

intradialytic physical training programOTHER

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.

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (18)

  • 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.

    PMID: 8820897BACKGROUND

  • 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.

    PMID: 12472795BACKGROUND

  • 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.

    PMID: 19828531BACKGROUND

  • 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.

    PMID: 10230881BACKGROUND

  • 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.

    PMID: 23560491BACKGROUND

  • 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.

    PMID: 23598747BACKGROUND

  • 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.

    PMID: 21412149BACKGROUND

  • 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.

    PMID: 13470504BACKGROUND

  • 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.

    PMID: 9624661BACKGROUND

  • 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.

    PMID: 8778555BACKGROUND

  • 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.

    PMID: 9719158BACKGROUND

  • 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.

    PMID: 12091180BACKGROUND

  • 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.

    PMID: 12460041BACKGROUND

  • 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.

    PMID: 12148109BACKGROUND

  • 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.

    PMID: 16635631BACKGROUND

  • 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.

    PMID: 9105067BACKGROUND

  • 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.

    PMID: 17828578BACKGROUND

  • 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.

    PMID: 20482853BACKGROUND

Related Links

MeSH Terms

Conditions

Kidney Failure, ChronicMotor Activity

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Paula I Moscoso, Mph PTh

    Universidad Austral de Chile

    STUDY CHAIR

  • Roberto G Mancilla, Student

    Universidad Austral de Chile

    PRINCIPAL INVESTIGATOR

  • Cesar E Gonzalez, Student

    Universidad Austral de Chile

    PRINCIPAL INVESTIGATOR

  • Manuel Monrroy, Msc(c) PTh

    Universidad Austral de Chile

    STUDY DIRECTOR

  • Lizzy Orellana, MD

    Universidad Austral de Chile

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2016

First Posted

August 30, 2016

Study Start

November 1, 2013

Primary Completion

January 1, 2014

Study Completion

March 1, 2014

Last Updated

September 30, 2016

Record last verified: 2016-09