NCT Number: NCT02621918
The Effects of Exercise in End-stage Renal Disease Patients Undergoing Hemodialysis
We aimed to investigate the effect of a progressive resistance training and aerobic training protocol on functional capacity, body composition and quality of life.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Aerobic training
OtherPlacebo Training
OtherPrimary outcomes
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Body composition by Dual-energy x-ray absorptiometry (DEXA)
Time frame: before and after 12 and 24 weeks of study
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.
Secondary outcomes
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Quality of life assessed by the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)
Time frame: before and after 12 and 24 weeks of study
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.
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Functional capacity
Time frame: before and after 12 and 24 weeks of study
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.
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Pulmonary capacity
Time frame: 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.
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.
Sponsors and collaborators
Lead sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Other
Registry information
Official study title
The Effects of an Intradialytic Progressive Resistance and Aerobic Training in End-stage Renal Disease Patients Undergoing Hemodialysis
Acronym: EESRDS
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2014
- First posted
- Dec 4, 2015
- Registry last updated
- Jul 27, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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