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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
Sponsor:
Collaborator:
Nephrocare Portugal
Information provided by (Responsible Party):
Universidad Austral de Chile

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.

Condition or disease Intervention/treatment
Chronic Renal Failure Other: intradialytic physical training program

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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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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883309


Sponsors and Collaborators
Universidad Austral de Chile
Nephrocare Portugal
Investigators
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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
Additional Information:
Publications:

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Responsible Party: Universidad Austral de Chile
ClinicalTrials.gov Identifier: NCT02883309    
Other Study ID Numbers: Universidad Austral de Chile
33-2013 ( Other Grant/Funding Number: DE-UACh )
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Keywords provided by Universidad Austral de Chile:
Hemodialysis
Skeletal muscle
Exercise
Rehabilitation
Disability Evaluation
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases