Effects of Resistance Training on Physical Activity in Daily Life and Functional Capacity in Hemodialysis Patients

January 7, 2016 updated by: Maycon de Moura Reboredo, Federal University of Juiz de Fora

Effects of Resistance Training on Physical Activity in Daily Life, Muscle Function and Functional Capacity in Patients With End Stage Renal Disease on Hemodialysis: a Randomised Controlled Trial

The purpose of this study is to determine whether a supervised resistance exercise training during hemodialysis is effective to increase physical activity in daily life in patients with end stage renal disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The patients will be randomized into two groups: intervention and control groups. Patients in the intervention group will receive a supervised resistance exercise training, during hemodialysis, three times/week for 12 weeks, and patients allocate to the control group will received a passive stretching program during the same timeframe.

Study Type

Interventional

Enrollment (Anticipated)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36038-330
        • Recruiting
        • University Hospital of the Federal University of Juiz de Fora
        • Contact:
        • Principal Investigator:
          • Felipe M Valle

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with end stage renal disease on hemodialysis for at least three months
  • Sedentary for at least six months

Exclusion Criteria:

  • Presence of physical limitations that prevent the implementation of physical tests
  • Presence of severe comorbidity and unstable (unstable angina, decompensated heart failure, myocardial infarction history of the past six months, cardiac arrhythmias, uncontrolled hypertension with systolic blood pressure ≥ 200 mmHg and / or diastolic blood pressure ≥ 120 mmHg, diabetes decompensated, severe lung disease, acute systemic infection as well as neurological disorders, musculoskeletal and osteoarticular or other disabling conditions according to the clinical judgment)
  • Hospitalization in the three months prior to study entry

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resistance Exercise Program
Patients included in intervention group will submit to resistance exercise training during hemodialysis, three times a week, for twelve weeks. This program includes exercises for the upper and lower limbs.
Other: Resistance Exercise Program
During the first week of training will be conducted two sets of 10 repetitions, and from the second week of training until the twelfth will be performed three sets of 10 repetitions. The work rate will set to the tolerance of each patient as established by his/her inability to maintain Borg ratings for dyspnea and effort (10-point category-ratio Borg scale) scores between "4" and "6".
No Intervention: Passive Stretching Program
Patients included in control group will submit to passive stretching program of lower limbs, during hemodialysis, three times a week, for twelve weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity in Daily Life
Time Frame: 12 weeks
The physical activity in daily life will be estimated as the mean number of steps using a triaxial accelerometer.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle function
Time Frame: 12 weeks
The muscle function will be assessed by electromyography.
12 weeks
Muscle strength
Time Frame: 12 weeks
The measurement of maximal voluntary strength of handgrip will be assessed by hydraulic model of dynamometer.
12 weeks
Functional capacity
Time Frame: 12 weeks
The functional capacity will be assessed by six-minute walking test.
12 weeks
Quality of life
Time Frame: 12 weeks
The quality of life will be assessed by the 36-Item Short Form Health Survey (SF36).
12 weeks
Depression and anxiety
Time Frame: 12 weeks
Depression and anxiety will be assessed by the Hospital Anxiety and Depression Scale.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Juiz de Fora

Investigators

  • Study Director: Maycon M Reboredo, DSc, Federal University of Juiz de Fora
  • Principal Investigator: Felipe M Valle, Federal University of Juiz de Fora
  • Study Director: Bruno V Pinheiro, DSc, Federal University of Juiz de Fora

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

January 7, 2016

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimate)

January 8, 2016

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE:44426115.0.0000.5147

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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