Efficacy of an Intradialysis Combined Training Program on Disability Level and Physical Performance. (PTH-CKD0113)
Primary Purpose
Chronic Renal Failure
Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
intradialytic physical training program
Sponsored by
About this trial
This is an expanded access trial for Chronic Renal Failure focused on measuring Hemodialysis, Skeletal muscle, Exercise, Rehabilitation, Disability Evaluation
Eligibility Criteria
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:
- 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02883309
First Posted
August 25, 2016
Last Updated
September 28, 2016
Sponsor
Universidad Austral de Chile
Collaborators
Nephrocare Portugal
1. Study Identification
Unique Protocol Identification Number
NCT02883309
Brief Title
Efficacy of an Intradialysis Combined Training Program on Disability Level and Physical Performance.
Acronym
PTH-CKD0113
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.
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Approved for marketing
Study Start Date
November 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Austral de Chile
Collaborators
Nephrocare Portugal
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure
Keywords
Hemodialysis, Skeletal muscle, Exercise, Rehabilitation, Disability Evaluation
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
intradialytic physical training program
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula I Moscoso, Mph PTh
Organizational Affiliation
Universidad Austral de Chile
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Roberto G Mancilla, Student
Organizational Affiliation
Universidad Austral de Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cesar E Gonzalez, Student
Organizational Affiliation
Universidad Austral de Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manuel Monrroy, Msc(c) PTh
Organizational Affiliation
Universidad Austral de Chile
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lizzy Orellana, MD
Organizational Affiliation
Universidad Austral de Chile
Official's Role
Study Director
12. IPD Sharing Statement
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Links:
URL
http://www.scielo.cl/scielo.php?pid=S0034-98872011000800010&script=sci_arttext
Description
Estudio piloto sobre entrenamiento físico durante hemodiálisis
URL
https://www.google.cl/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=0CB4QFjAA&url=http%3A%2F%2Fwww.researchgate.net%2Fprofile%2FLuis_Gaite%2Fpublication%2F230554738_Version_en_lengua_espaola_de_un_nuevo_cuestionario_de_evaluacion_de_disca
Description
Whodas II Acta Psiquiatrica
URL
http://www.biomedcentral.com/1471-2369/10/2
Description
Intradialytic versus home based exercise training in hemodialysis patients: a randomised controlled trial
URL
http://www.revistas.usp.br/fpusp/article/view/12081
Description
Efeitos do exercício físico durante a hemodiálise em indivíduos com insuficiência renal crônica: uma revisão
Learn more about this trial
Efficacy of an Intradialysis Combined Training Program on Disability Level and Physical Performance.
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