Efficacy of an Intradialysis Combined Training Program on Disability Level and Physical Performance. (PTH-CKD0113)
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|ClinicalTrials.gov Identifier: NCT02883309|
Expanded Access Status : Approved for marketing
First Posted : August 30, 2016
Last Update Posted : September 30, 2016
|Condition or disease||Intervention/treatment|
|Chronic Renal Failure||Other: intradialytic physical training program|
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 Type :||Expanded Access|
|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 Start Date :||November 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||March 2014|
- Other: intradialytic 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883309
|Study Chair:||Paula I Moscoso, Mph PTh||Universidad Austral de Chile|
|Principal Investigator:||Roberto G Mancilla, Student||Universidad Austral de Chile|
|Principal Investigator:||Cesar E Gonzalez, Student||Universidad Austral de Chile|
|Study Director:||Manuel Monrroy, Msc(c) PTh||Universidad Austral de Chile|
|Study Director:||Lizzy Orellana, MD||Universidad Austral de Chile|