Renal Insufficiency, ChronicNCT02651025
Effects of Resistance Training on Physical Activity in Daily Life and Functional Capacity in Hemodialysis Patients
A study testing Resistance Exercise Program in people with Renal Insufficiency, Chronic, run by Federal University of Juiz de Fora at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether a supervised resistance exercise training during hemodialysis is effective to increase physical activity in daily life in patients with end stage renal disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Resistance Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2016to Mar 2017
- 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
- Patients with end stage renal disease on hemodialysis for at least three months
- Sedentary for at least six months
Who cannot join
- Presence of physical limitations that prevent the implementation of physical tests
- Presence of severe comorbidity and unstable (unstable angina, decompensated heart failure, myocardial infarction history of the past six months, cardiac arrhythmias, uncontrolled hypertension with systolic blood pressure ≥ 200 mmHg and / or diastolic blood pressure ≥ 120 mmHg, diabetes decompensated, severe lung disease, acute systemic infection as well as neurological disorders, musculoskeletal and osteoarticular or other disabling conditions according to the clinical judgment)
- Hospitalization in the three months prior to study entry
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University Hospital of the Federal University of Juiz de Fora
Juiz de Fora, Minas Gerais, 36038-330
Maycon M Reboredo, DSc, 5532988365529, mayconreboredo@yahoo.com.br
Felipe M Valle
About this study
Official title: Effects of Resistance Training on Physical Activity in Daily Life, Muscle Function and Functional Capacity in Patients With End Stage Renal Disease on Hemodialysis: a Randomised Controlled Trial
The purpose of this study is to determine whether a supervised resistance exercise training during hemodialysis is effective to increase physical activity in daily life in patients with end stage renal disease.
Read the detailed description
The patients will be randomized into two groups: intervention and control groups. Patients in the intervention group will receive a supervised resistance exercise training, during hemodialysis, three times/week for 12 weeks, and patients allocate to the control group will received a passive stretching program during the same timeframe.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Resistance Exercise Program
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Exercise ProgramOther
During the first week of training will be conducted two sets of 10 repetitions, and from the second week of training until the twelfth will be performed three sets of 10 repetitions. The work rate will set to the tolerance of each patient as established by his/her inability to maintain Borg ratings for dyspnea and effort (10-point category-ratio Borg scale) scores between "4" and "6".
| Study group | Role | What they receive |
|---|---|---|
| Resistance Exercise Program | Experimental | Patients included in intervention group will submit to resistance exercise training during hemodialysis, three times a week, for twelve weeks. This program includes exercises for the upper and lower limbs. Receives: Other: Resistance Exercise Program |
| Passive Stretching Program | No intervention | Patients included in control group will submit to passive stretching program of lower limbs, during hemodialysis, three times a week, for twelve weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity in Daily Life
The physical activity in daily life will be estimated as the mean number of steps using a triaxial accelerometer.
Measured: 12 weeks
Secondary outcomes (5)
Muscle function
The muscle function will be assessed by electromyography.
Measured: 12 weeks
Muscle strength
The measurement of maximal voluntary strength of handgrip will be assessed by hydraulic model of dynamometer.
Measured: 12 weeks
Functional capacity
The functional capacity will be assessed by six-minute walking test.
Measured: 12 weeks
Quality of life
The quality of life will be assessed by the 36-Item Short Form Health Survey (SF36).
Measured: 12 weeks
Depression and anxiety
Depression and anxiety will be assessed by the Hospital Anxiety and Depression Scale.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionMar 2017 (estimated)
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 Renal Insufficiency, ChronicStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Juiz de Fora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maycon de Moura Reboredo, Federal University of Juiz de Fora
- Investigators
- Maycon M Reboredo, DSc, Study director, Federal University of Juiz de ForaFelipe M Valle, Principal investigator, Federal University of Juiz de ForaBruno V Pinheiro, DSc, Study director, Federal University of Juiz de Fora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651025
- Sponsor's protocol ID
- CAAE:44426115.0.0000.5147
- Status last verified
- Jan 2016
- First submitted
- 7 Jan 2016
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
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 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Training on Physical Activity in Daily Life, Muscle Function and Functional Capacity in Patients With End Stage Renal Disease on Hemodialysis: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02651025
- Acronym / sponsor ID
- CAAE:44426115.0.0000.5147
- Conditions
- Renal Insufficiency, Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Federal University of Juiz de ForaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 8 Jan 2016 (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.
The purpose of this study is to determine whether a supervised resistance exercise training during hemodialysis is effective to increase physical activity in daily life in patients with end stage renal disease.
Detailed description
The patients will be randomized into two groups: intervention and control groups. Patients in the intervention group will receive a supervised resistance exercise training, during hemodialysis, three times/week for 12 weeks, and patients allocate to the control group will received a passive stretching program during the same timeframe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise Program | Experimental | Other: Resistance Exercise ProgramPatients included in intervention group will submit to resistance exercise training during hemodialysis, three times a week, for twelve weeks. This program includes exercises for the upper and lower limbs. |
| Passive Stretching Program | No intervention | –Patients included in control group will submit to passive stretching program of lower limbs, during hemodialysis, three times a week, for twelve weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with end stage renal disease on hemodialysis for at least three months
- Sedentary for at least six months
Key exclusion criteria (3 listed)
- Presence of physical limitations that prevent the implementation of physical tests
- Presence of severe comorbidity and unstable (unstable angina, decompensated heart failure, myocardial infarction history of the past six months, cardiac arrhythmias, uncontrolled hypertension with systolic blood pressure ≥ 200 mmHg and / or diastolic blood pressure ≥ 120 mmHg, diabetes decompensated, severe lung disease, acute systemic infection as well as neurological disorders, musculoskeletal and osteoarticular or other disabling conditions according to the clinical judgment)
- Hospitalization in the three months prior to study entry
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 |
|---|---|---|
| Resistance Exercise ProgramDuring the first week of training will be conducted two sets of 10 repetitions, and from the second week of training until the twelfth will be performed three sets of 10 repetitions. The work rate will set to the tolerance of each patient as established by his/her inability to maintain Borg ratings for dyspnea and effort (10-point category-ratio Borg scale) scores between "4" and "6". | Other | Resistance Exercise Program |
Primary outcome
Physical Activity in Daily Life
Time frame: 12 weeks
The physical activity in daily life will be estimated as the mean number of steps using a triaxial accelerometer.
5 secondary outcomes
Muscle function
Time frame: 12 weeks
Muscle strength
Time frame: 12 weeks
Functional capacity
Time frame: 12 weeks
Quality of life
Time frame: 12 weeks
Depression and anxiety
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 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.
Related trials for Renal Insufficiency, Chronic
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Maycon M Reboredo, DSc study director
Federal University of Juiz de Fora
Felipe M Valle principal investigator
Federal University of Juiz de Fora
Bruno V Pinheiro, DSc study director
Federal University of Juiz de Fora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise Program in people with Renal Insufficiency, Chronic, run by Federal University of Juiz de Fora at 1 site in Brazil.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felipe M Valle (5532988579609, felipemartins.valle@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity in Daily Life (time frame: 12 weeks). 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 NCT02651025, 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 8 Jan 2016.