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

NCT ID: NCT02651025

Last Updated: 2016-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Renal Insufficiency, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Resistance Exercise Program

Intervention Type OTHER

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".

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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".

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Juiz de Fora

OTHER

Sponsor Role lead

Responsible Party

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Maycon de Moura Reboredo

Professor of School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maycon M Reboredo, DSc

Role: STUDY_DIRECTOR

Federal University of Juiz de Fora

Felipe M Valle

Role: PRINCIPAL_INVESTIGATOR

Federal University of Juiz de Fora

Bruno V Pinheiro, DSc

Role: STUDY_DIRECTOR

Federal University of Juiz de Fora

Locations

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University Hospital of the Federal University of Juiz de Fora

Juiz de Fora, Minas Gerais, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Felipe M Valle

Role: CONTACT

5532988579609

Maycon Reboredo, DSc

Role: CONTACT

5532988365529

Facility Contacts

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Maycon M Reboredo, DSc

Role: primary

5532988365529

References

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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.

Reference Type DERIVED
PMID: 35018639 (View on PubMed)

Other Identifiers

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CAAE:44426115.0.0000.5147

Identifier Type: -

Identifier Source: org_study_id

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