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

Renal Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834026
• Other study ID #: 1.398.846
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 30, 2018

Study information

• Verified date: November 2019
• Source: Faculdade de Ciências Médicas da Santa Casa de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 30, 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Dialysis
• Renal Insufficiency, Chronic

Intervention

Other:
• Cicloergometry training

• No Cicloergometry training

Locations

Country	Name	City	State
Brazil	Vera Lúcia dos Santos Alves	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Ciências Médicas da Santa Casa de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength evaluated by dynamometry	dynamometry	Two months
Primary	Peripheral blood tests	hemoglobin (g / dL)	Two months
Primary	Peripheral blood tests	serum albumin (GDL)	Two months
Primary	Peripheral blood tests	Creatinine (mg / dL)	Two months
Primary	Peripheral blood tests	Urea (mg / dL)	Two months
Primary	Peripheral blood tests	Kt / V	Two months