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

Sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT02834026

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Renal Disease Renal Dialysis	Other: Cicloergometry training Other: No Cicloergometry training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jan 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention The intervention group held two months of training in hemodialysis a physical therapy protocol with cycle ergometer	Other: Cicloergometry training
Experimental: Control The control group was reassessed after two months of the initial evaluation	Other: No Cicloergometry training

Arm

Intervention/Treatment

Experimental: Intervention

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

Other: Cicloergometry training

Experimental: Control

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

Other: No Cicloergometry training

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.