Efficacy of an Intradialysis Combined Training Program on Disability Level and Physical Performance. (PTH-CKD0113)

September 28, 2016 updated by: Universidad Austral de Chile

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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

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 Type

Expanded Access

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

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Sponsor

Universidad Austral de Chile

Collaborators

Nephrocare Portugal

Investigators

  • 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

Publications and helpful links

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General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 25, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (Estimate)

August 30, 2016

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Universidad Austral de Chile
  • 33-2013 (Other Grant/Funding Number: DE-UACh)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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