NCT02651025

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

January 7, 2016

Last Update Submit

January 7, 2016

Conditions

Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

  • Physical Activity in Daily Life

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

    12 weeks

Secondary Outcomes (5)

  • Muscle function

    12 weeks

  • Muscle strength

    12 weeks

  • Functional capacity

    12 weeks

  • Quality of life

    12 weeks

  • Depression and anxiety

    12 weeks

Study Arms (2)

Resistance Exercise Program

EXPERIMENTAL

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

Passive Stretching Program

NO INTERVENTION

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

Interventions

Resistance Exercise ProgramOTHER

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".

Resistance Exercise Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of the Federal University of Juiz de Fora

Juiz de Fora, Minas Gerais, 36038-330, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35018639DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maycon M Reboredo, DSc

    Federal University of Juiz de Fora

    STUDY DIRECTOR

  • Felipe M Valle

    Federal University of Juiz de Fora

    PRINCIPAL INVESTIGATOR

  • Bruno V Pinheiro, DSc

    Federal University of Juiz de Fora

    STUDY DIRECTOR

Central Study Contacts

Felipe M Valle

CONTACT

5532988579609felipemartins.valle@gmail.com

Maycon Reboredo, DSc

CONTACT

5532988365529mayconreboredo@yahoo.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of School of Medicine

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 8, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

BR(1)