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

End Stage Renal Failure on Dialysis Clinical Trial

— EESRDS  

Official title:

The Effects of an Intradialytic Progressive Resistance and Aerobic Training in End-stage Renal Disease Patients Undergoing Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621918
• Other study ID #: CAAE-02564112.2.0000.5423
• Status: Completed
• Phase: N/A
• First received: October 21, 2015
• Last updated: July 25, 2016
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2016
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Failure on Dialysis
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• Progressive resistance training

• Aerobic training

• Placebo training

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	before and after 12 and 24 weeks of study	Yes
Secondary	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.	before and after 12 and 24 weeks of study	Yes
Secondary	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.	before and after 12 and 24 weeks of study	Yes
Secondary	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.	before and after 12 and 24 weeks of study. Additionally this variable was assessed over the three time points before and after one hemodialysis session.	Yes