End Stage Renal Failure on DialysisEESRDSNCT02621918
The Effects of Exercise in End-stage Renal Disease Patients Undergoing Hemodialysis
A study testing Progressive resistance training and Aerobic training in people with End Stage Renal Failure on Dialysis, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Failure on Dialysis
- What is being tested?
- Progressive resistance training and Aerobic training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients in wheelchair, presenting disability, or those who had amputation and malformation of the lower limbs, causing impaired walking
- presenting representative blindness
About this study
Official title: 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.
Read the 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.
- Conditions
- End Stage Renal Failure on Dialysis
- Being tested
- Progressive resistance training, Aerobic training, Placebo training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive resistance trainingOther
Aerobic trainingOther
Placebo trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Progressive Resistance Training (PRT) | Experimental | 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). Receives: Other: Progressive resistance training |
| Aerobic Exercise (AER) | Experimental | 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. Receives: Other: Aerobic training |
| NEPLA | Placebo comparator | 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. Receives: Other: Placebo training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before and after 12 and 24 weeks of study
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startMar 2013
- Primary completionSep 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Failure on DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clara S C Rosa, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621918
- Sponsor's protocol ID
- CAAE-02564112.2.0000.5423
- Acronym
- EESRDS
- Status last verified
- Jul 2016
- First submitted
- 21 Oct 2015
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
PubMed 35018639
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Intradialytic Progressive Resistance and Aerobic Training in End-stage Renal Disease Patients Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT02621918
- Acronym / sponsor ID
- EESRDS / CAAE-02564112.2.0000.5423
- Conditions
- End Stage Renal Failure on Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aimed to investigate the effect of a progressive resistance training and aerobic training protocol on functional capacity, body composition and quality of life.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Progressive Resistance Training (PRT) | Experimental | Other: Progressive resistance trainingFor 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). |
| Aerobic Exercise (AER) | Experimental | Other: Aerobic trainingAerobic 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. |
| NEPLA | Placebo comparator | Other: Placebo trainingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients in wheelchair, presenting disability, or those who had amputation and malformation of the lower limbs, causing impaired walking
- presenting representative blindness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive resistance training | Other | Progressive Resistance Training (PRT) |
| Aerobic training | Other | Aerobic Exercise (AER) |
| Placebo training | Other | NEPLA |
Primary outcome
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.
3 secondary outcomes
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
Functional capacity
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- Derived from this study: PubMed 35018639Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive resistance training and Aerobic training in people with End Stage Renal Failure on Dialysis, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition by Dual-energy x-ray absorptiometry (DEXA) (time frame: before and after 12 and 24 weeks of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02621918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2016.