Chronic Renal FailurePTH-CKD0113NCT02883309
Efficacy of an Intradialysis Combined Training Program on Disability Level and Physical Performance.
A study testing intradialytic physical training program in people with Chronic Renal Failure, run by Universidad Austral de Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- intradialytic physical training program
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Nov 2013to Mar 2014
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
About this study
Official title: Efficacy of an Intradialysis Combined Muscle Strength and Cardiorespiratory Capacity Training Program on Disability Level and Physical Performance, in Patients With Chronic Renal Failure at a Kidney Replacement Therapy Unit.
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.
- Conditions
- Chronic Renal Failure
- Being tested
- intradialytic physical training program
- Keywords
- Hemodialysis, Skeletal muscle, Exercise, Rehabilitation, Disability Evaluation
- Medical subject headings
- Kidney Failure, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startNov 2013
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Universidad Austral de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Nephrocare Portugal
- Responsible party
- Sponsor
- Investigators
- Paula I Moscoso, Mph PTh, Study chair, Universidad Austral de ChileRoberto G Mancilla, Student, Principal investigator, Universidad Austral de ChileCesar E Gonzalez, Student, Principal investigator, Universidad Austral de ChileManuel Monrroy, Msc(c) PTh, Study director, Universidad Austral de ChileLizzy Orellana, MD, Study director, Universidad Austral de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883309
- Sponsor's protocol ID
- Universidad Austral de Chile
- Other IDs
- 33-2013
- Acronym
- PTH-CKD0113
- Status last verified
- Sep 2016
- First submitted
- 25 Aug 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
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 8820897Johansen 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 12472795Kurella 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 19828531Johansen 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 10230881de 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 23560491Ribeiro 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 23598747Giannaki 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 21412149KARVONEN 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 13470504American 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 9624661Stoudemire 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 8778555Mercer 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 9719158ATS 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 12091180DePaul 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 12460041Headley 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 12148109Parsons 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Intradialysis Combined Muscle Strength and Cardiorespiratory Capacity Training Program on Disability Level and Physical Performance, in Patients With Chronic Renal Failure at a Kidney Replacement Therapy Unit.
- ClinicalTrials.gov ID
- NCT02883309
- Acronym / sponsor ID
- PTH-CKD0113 / Universidad Austral de Chile
- Conditions
- Chronic Renal Failure
- Keywords
- Hemodialysis, Skeletal muscle, Exercise, Rehabilitation, Disability Evaluation
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Universidad Austral de ChileUniversity, hospital or other
- Collaborators
- Nephrocare Portugal
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intradialytic physical training programNine 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. | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Background: PubMed 8820897Marriott 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.
- Background: PubMed 12472795Johansen 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.
- Background: PubMed 19828531Kurella 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.
- Background: PubMed 10230881Johansen 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.
- Background: PubMed 23560491de 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.
- Background: PubMed 23598747Ribeiro 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.
- Background: PubMed 21412149Giannaki 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.
- Background: PubMed 13470504KARVONEN 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.
- Background: PubMed 9624661American 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.
- Background: PubMed 8778555Stoudemire 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.
- Background: PubMed 9719158Mercer 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.
- Background: PubMed 12091180ATS 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.
- Whodas II Acta PsiquiatricaLink provided by the sponsor.
- e nfermedad renal crónica: causa y prevalencia en la población del Hospital general la PerlaLink provided by the sponsor.
- Intradialytic versus home based exercise training in hemodialysis patients: a randomised controlled trialLink provided by the sponsor.
- Efeitos do exercício físico durante a hemodiálise em indivíduos com insuficiência renal crônica: uma revisãoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
A study testing intradialytic physical training program in people with Chronic Renal Failure, run by Universidad Austral de Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02883309, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.