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

NCT ID: NCT02834026

Last Updated: 2019-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-01-30

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.

Conditions

Chronic Renal Disease; Renal Dialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Cicloergometry training

Intervention Type: OTHER

Control

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

Group Type: EXPERIMENTAL

No Cicloergometry training

Intervention Type: OTHER

Interventions

Cicloergometry training

Intervention Type: OTHER

No Cicloergometry training

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Faculdade de Ciências Médicas da Santa Casa de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Profa. Dra. Vera Lúcia dos Santos Alves

PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vera Lúcia dos Santos Alves

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 35018639 (View on PubMed)

Other Identifiers

1.398.846

Identifier Type: -

Identifier Source: org_study_id