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

July 25, 2016 updated by: Clara S C Rosa, Universidade Estadual Paulista Júlio de Mesquita Filho

The Effects of an Intradialytic Progressive Resistance and Aerobic Training 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Progressive Resistance Training (PRT)
For the progressive resistance training we use 11 exercises. The exercises for upper limbs were held in the waiting room before the hemodialysis session. Resistance exercise was carried out in two sets of 15-20 repetitions, the intensity were determined by the method of maximal repetitions, where series were run until exhaustion to momentary exercises (15-20 repetitions) with specific load. The load adjustments or volume were managed when necessary, but necessarily for every 4th week of training. The effort perception should be situated between 12 and 16 on the Borg scale (Borg and Noble, 1974), as proposed by The Life Options Rehabilitation Advisory Council: Exercise for the Patient Dialysis (1995).
Other: Progressive resistance training
Experimental: Aerobic Exercise (AER)
Aerobic exercise was conducted with a mini ergometer cycling (Mini Bike E5 Acte Sports) attached to the patient chair. Patients exercised 50-60 minutes of continuous workout with increased load. The workload was adjusted when necessary, according to the perceived effort made by the patient. The scale of perceived exertion, Borg scale (Borg and Noble , 1974), was used in accordance with the proposed By The Life Options Rehabilitation Advisory Council: Exercise for the Patient Dialysis (1995), which defines the values of perceived exertion between 12 and 16.
Other: Aerobic training
Placebo Comparator: NEPLA
The control group performed active mobilization of members, circumduction of cervical, scapular girdle and extremities, breathing exercises with no loads, set on three to five repetitions only and no stretch exercises. The exercises were performed during the hemodialysis session, three times per week and did not exceed 5 minutes.
Other: Placebo training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
before and after 12 and 24 weeks of study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
before and after 12 and 24 weeks of study
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.
before and after 12 and 24 weeks of study
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Estadual Paulista Júlio de Mesquita Filho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAAE-02564112.2.0000.5423

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