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Impact of the Cycle Ergometer in Muscle Strength and Pulmonary Function in Patients in Hemodialysis

Primary Purpose

Chronic Renal Disease, Renal Dialysis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cicloergometry training
No Cicloergometry training
Sponsored by
Faculdade de Ciências Médicas da Santa Casa de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Renal Disease focused on measuring Muscle Strength, Muscle Strength Dynamometer, Chronic Renal Disease, Exercise, Physical therapy modalities

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Vera Lúcia dos Santos Alves

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Muscle strength evaluated by dynamometry
dynamometry
Peripheral blood tests
hemoglobin (g / dL)
Peripheral blood tests
serum albumin (GDL)
Peripheral blood tests
Creatinine (mg / dL)
Peripheral blood tests
Urea (mg / dL)
Peripheral blood tests
Kt / V

Secondary Outcome Measures

Full Information

First Posted
July 5, 2016
Last Updated
November 27, 2019
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02834026
Brief Title
Impact of the Cycle Ergometer in Muscle Strength and Pulmonary Function in Patients in Hemodialysis
Official Title
Impact of the Cycle Ergometer in Muscle Strength and Pulmonary Function in Patients in Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
January 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Disease, Renal Dialysis
Keywords
Muscle Strength, Muscle Strength Dynamometer, Chronic Renal Disease, Exercise, Physical therapy modalities

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention group held two months of training in hemodialysis a physical therapy protocol with cycle ergometer
Arm Title
Control
Arm Type
Experimental
Arm Description
The control group was reassessed after two months of the initial evaluation
Intervention Type
Other
Intervention Name(s)
Cicloergometry training
Intervention Type
Other
Intervention Name(s)
No Cicloergometry training
Primary Outcome Measure Information:
Title
Muscle strength evaluated by dynamometry
Description
dynamometry
Time Frame
Two months
Title
Peripheral blood tests
Description
hemoglobin (g / dL)
Time Frame
Two months
Title
Peripheral blood tests
Description
serum albumin (GDL)
Time Frame
Two months
Title
Peripheral blood tests
Description
Creatinine (mg / dL)
Time Frame
Two months
Title
Peripheral blood tests
Description
Urea (mg / dL)
Time Frame
Two months
Title
Peripheral blood tests
Description
Kt / V
Time Frame
Two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
Vera Lúcia dos Santos Alves
City
São Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
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

Learn more about this trial

Impact of the Cycle Ergometer in Muscle Strength and Pulmonary Function in Patients in Hemodialysis

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