Combined Resistance and Aerobic Exercise is Better Than Resistance Training Alone to Improve Functional Performance of Hemodialysis Patients - Results of a Randomized Trial

NCT ID: NCT01076881

Last Updated: 2010-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-03-31

Brief Summary

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This is a randomized trial with participants recruited from one dialysis unit of a Brazilian university hospital. Hemodialysis patients were assigned to receive the resistance exercise combined with an aerobic training or the resistance training alone for a period of 10 weeks. The functional performance of patients was assessed before and after the intervention through the six-minute walk test (6MWT). The difference over time of the 6MWT was compared between the groups through multivariate linear regression.

Thirteen patients were allocated for each group of intervention. The difference in distance walked before and after intervention in the combined training group was of +39.7 (61.4) meters, and this difference in the resistance training group was of -19.2 (53.9) meters, p=0.01. In multivariate analysis with adjustment for age, skin color, gender, hematocrit, time since starting dialysis, Kt/V and baseline values of 6MWT, the type of training remained significantly associated with the amount of increase in walked distance.

Although the best protocol of exercise for patients on dialysis is not yet clear, in the investigators sample of hemodialysis patients the combination of aerobic and resistance training was more effective to improve functional performance.

Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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combined aerobic and resistance training

Group Type EXPERIMENTAL

exercise training

Intervention Type BEHAVIORAL

resistance training alone

Group Type ACTIVE_COMPARATOR

exercise training

Intervention Type BEHAVIORAL

Interventions

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exercise training

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* to be on hemodialysis therapy for longer than 3 months
* to be already included in the resistance training protocol during dialysis
* to receive erythropoietin for the treatment of anemia
* hemoglobin level greater than 9.0 g/dL
* to be able to maintain sitting and standing balance and ambulatory without assistance.

Exclusion Criteria

* symptomatic ischemic heart disease
* recent myocardial infarction of less than 6 months
* uncontrolled hypertension
* pericardial or pleural friction rub
* aortic stenosis
* active musculoskeletal lower-extremity problem, or history of vertebral fracture caused by osteoporosis
* patients were also excluded if they participated in formal organized exercise programs outside the dialysis unit.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Católica de Pelotas

OTHER

Sponsor Role lead

Locations

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Hospital Universitário São Francisco de Paula

Pelotas, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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UCPelotas01

Identifier Type: -

Identifier Source: org_study_id