NCT02834026

Brief Summary

Muscle strength can be measured by dynamometry, but the investigators did not find in the literature the study of this technique in the quadriceps of patients with chronic kidney disease on hemodialysis. Analyze training impact conducted by cycle ergometer in quadriceps muscle strength in patients with chronic kidney disease during hemodialysis. This study will be a prospective, randomized. Inclusion of 46 patients followed by the dialysis unit of a university hospital, over 18 years, of both genders who underwent hemodialysis for more than six months and signed the consent form and enlightened. Patients will be divided into two groups: Intervention (n = 23) and control (n = 23). All will be evaluated for demographics and quadriceps strength given by standardization of technique, with hard and windy belt. The control group will be reassessed after two months of the initial assessment, since the intervention group held two months of training in hemodialysis a physical therapy protocol with the cycle ergometer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

December 2, 2019

Status Verified

November 1, 2019

Enrollment Period

1.4 years

First QC Date

July 5, 2016

Last Update Submit

November 27, 2019

Conditions

Chronic Renal DiseaseRenal Dialysis

Keywords

Muscle StrengthMuscle Strength DynamometerChronic Renal DiseaseExercisePhysical therapy modalities

Outcome Measures

Primary Outcomes (6)

  • Muscle strength evaluated by dynamometry

    dynamometry

    Two months

  • Peripheral blood tests

    hemoglobin (g / dL)

    Two months

  • Peripheral blood tests

    serum albumin (GDL)

    Two months

  • Peripheral blood tests

    Creatinine (mg / dL)

    Two months

  • Peripheral blood tests

    Urea (mg / dL)

    Two months

  • Peripheral blood tests

    Kt / V

    Two months

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group held two months of training in hemodialysis a physical therapy protocol with cycle ergometer

Other: Cicloergometry training

Control

EXPERIMENTAL

The control group was reassessed after two months of the initial evaluation

Other: No Cicloergometry training

Interventions

Cicloergometry trainingOTHER
Intervention
No Cicloergometry trainingOTHER
Control

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged over 18 years
  • Performing HD over six months
  • Clinically stable
  • Patients no diagnosis of lung disease
  • Neurological or mioarticular previous or current and agreed to participate in the study and signed informed consent and informed

You may not qualify if:

  • Patients undergoing elective surgery or emergency six months before or during the performance of the protocol
  • Cardiac decompensation
  • Used continuous or nocturnal oxygen
  • Patients using bracing of the lower limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vera Lúcia dos Santos Alves

São Paulo, São Paulo, Brazil

Location

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, ChronicMotor Activity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 15, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2017

Study Completion

January 30, 2018

Last Updated

December 2, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

Locations

BR(1)