The Effects of Exercise in End-stage Renal Disease Patients Undergoing Hemodialysis

N/ACompletedNCT02621918

Universidade Estadual Paulista Júlio de Mesquita Filho61 enrolled

Overview

We aimed to investigate the effect of a progressive resistance training and aerobic training protocol on functional capacity, body composition and quality of life.

Subjects were randomized into group A and B: group A (n=30) exercised for the first 6 months while group B (n=31) performed a placebo exercise initially (3 months) and cross-over to aerobic exercised for 3 months more.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End Stage Renal Failure on Dialysis

Interventions

Progressive resistance trainingOTHER

Aerobic trainingOTHER

Placebo trainingOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * older than 18 years * more than three months of hemodialysis vintage * under the permission of their nephrologist * agreement to be randomly assigned and undergo study protocols Exclusion Criteria: * Patients in wheelchair, presenting disability, or those who had amputation and malformation of the lower limbs, causing impaired walking * presenting representative blindness

Outcomes

Primary Outcomes

Body composition by Dual-energy x-ray absorptiometry (DEXA)

Dual-energy x-ray absorptiometry (DEXA) was used to measure lean body mass (LBM), fat mass (FM) and Bone Mineral Contend (BMC) in grams using a total body scan, following the equipment description - HOLOGIC Discovery Wi (Hologic inc, Waltham, MA, USA). Body composition variables included in this study were total mass, body FM, LBM and legs LBM, and BMC. Body composition was assessed after a hemodialysis day; time after previous hemodialysis did not exceed eight hours.

Time frame: before and after 12 and 24 weeks of study

Secondary Outcomes

Quality of life assessed by the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)

Quality of life assessment was analyzed using the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36). The SF-36 is composed of eleven issues of 36 items that assess eight dimensions events occurred in the last four weeks. For the presentation of the survey results, the final score of each domain was transformed into a scale from 0 (worse) to 100 (better). Total score, mental e physical dimensions were analyzed separated.

Time frame: before and after 12 and 24 weeks of study

Functional capacity

The 6 minutes walking test measured the walking capacity (distance in meters) during 6 minutes. The sit-to-stand test assessed the lower limbs strength resistance by times that the subject stand and sit (chair) during 30 seconds. And flexibility was assessed by sit and reach test.

Time frame: before and after 12 and 24 weeks of study

Pulmonary capacity

For the assessment of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) an analog manovacuometer (Gerar ®, 0±300 cmH2O) was used. Patients underwent three valid maneuvers and the most negative and most positive in MIP and MEP, respectively, were considered. Ventilometer (Ferraris Mark8 Wright Respirometer®) detected the low vital capacity (LVC). Reduced forced expiratory volume in one second (FEV1), reduced forced vital capacity (FVC), normal FEV1/FVC ratio, and forced expiratory flow between 25% and 75% of vital capacity (FEF25-27) were evaluated with the spirometer brand IQTeQ. Spirometric variables were analyzed in reference percentage values in order to eliminate the effects of age, height, and gender. The assay was performed in order to obtain three acceptable curves with at least two reproducible curves five minutes interval for each exam for a total of up to eight trials.

Data from ClinicalTrials.gov

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