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

Primary Purpose

Renal Insufficiency, Chronic

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Resistance Exercise Program
Sponsored by
Federal University of Juiz de Fora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of the Federal University of Juiz de ForaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Resistance Exercise Program

Passive Stretching Program

Arm Description

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.

Patients included in control group will submit to passive stretching program of lower limbs, during hemodialysis, three times a week, for twelve weeks.

Outcomes

Primary Outcome Measures

Physical Activity in Daily Life
The physical activity in daily life will be estimated as the mean number of steps using a triaxial accelerometer.

Secondary Outcome Measures

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

Full Information

First Posted
January 7, 2016
Last Updated
January 7, 2016
Sponsor
Federal University of Juiz de Fora
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1. Study Identification

Unique Protocol Identification Number
NCT02651025
Brief Title
Effects of Resistance Training on Physical Activity in Daily Life and Functional Capacity in Hemodialysis Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Juiz de Fora

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resistance Exercise Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Passive Stretching Program
Arm Type
No Intervention
Arm Description
Patients included in control group will submit to passive stretching program of lower limbs, during hemodialysis, three times a week, for twelve weeks.
Intervention Type
Other
Intervention Name(s)
Resistance Exercise Program
Intervention Description
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".
Primary Outcome Measure Information:
Title
Physical Activity in Daily Life
Description
The physical activity in daily life will be estimated as the mean number of steps using a triaxial accelerometer.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Muscle function
Description
The muscle function will be assessed by electromyography.
Time Frame
12 weeks
Title
Muscle strength
Description
The measurement of maximal voluntary strength of handgrip will be assessed by hydraulic model of dynamometer.
Time Frame
12 weeks
Title
Functional capacity
Description
The functional capacity will be assessed by six-minute walking test.
Time Frame
12 weeks
Title
Quality of life
Description
The quality of life will be assessed by the 36-Item Short Form Health Survey (SF36).
Time Frame
12 weeks
Title
Depression and anxiety
Description
Depression and anxiety will be assessed by the Hospital Anxiety and Depression Scale.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felipe M Valle
Phone
5532988579609
Email
felipemartins.valle@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maycon Reboredo, DSc
Phone
5532988365529
Email
mayconreboredo@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maycon M Reboredo, DSc
Organizational Affiliation
Federal University of Juiz de Fora
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Felipe M Valle
Organizational Affiliation
Federal University of Juiz de Fora
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno V Pinheiro, DSc
Organizational Affiliation
Federal University of Juiz de Fora
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of the Federal University of Juiz de Fora
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36038-330
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maycon M Reboredo, DSc
Phone
5532988365529
Email
mayconreboredo@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Felipe M Valle

12. IPD Sharing Statement

Citations:
PubMed Identifier
35018639
Citation
Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
Results Reference
derived

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

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