Chronic Renal DiseaseNCT02834026
Impact of the Cycle Ergometer in Muscle Strength and Pulmonary Function in Patients in Hemodialysis
A study testing Cicloergometry training and No Cicloergometry training in people with Chronic Renal Disease and Renal Dialysis, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial summary
Muscle strength can be measured by dynamometry, but the investigators did not find in the literature the study of this technique in the quadriceps of patients with chronic kidney disease on hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Disease, Renal Dialysis
- What is being tested?
- Cicloergometry training and No Cicloergometry training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2016to 30 Jan 2018
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged over 18 years
- Performing HD over six months
- Clinically stable
- Patients no diagnosis of lung disease
- Neurological or mioarticular previous or current and agreed to participate in the study and signed informed consent and informed
Who cannot join
- Patients undergoing elective surgery or emergency six months before or during the performance of the protocol
- Cardiac decompensation
- Used continuous or nocturnal oxygen
- Patients using bracing of the lower limbs.
Trial locations and contacts
1 site in 1 country.
About this study
Muscle strength can be measured by dynamometry, but the investigators did not find in the literature the study of this technique in the quadriceps of patients with chronic kidney disease on hemodialysis. Analyze training impact conducted by cycle ergometer in quadriceps muscle strength in patients with chronic kidney disease during hemodialysis. This study will be a prospective, randomized. Inclusion of 46 patients followed by the dialysis unit of a university hospital, over 18 years, of both genders who underwent hemodialysis for more than six months and signed the consent form and enlightened. Patients will be divided into two groups: Intervention (n = 23) and control (n = 23). All will be evaluated for demographics and quadriceps strength given by standardization of technique, with hard and windy belt. The control group will be reassessed after two months of the initial assessment, since the intervention group held two months of training in hemodialysis a physical therapy protocol with the cycle ergometer.
- Conditions
- Chronic Renal Disease, Renal Dialysis
- Being tested
- Cicloergometry training, No Cicloergometry training
- Keywords
- Muscle Strength, Muscle Strength Dynamometer, Chronic Renal Disease, Exercise, Physical therapy modalities
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cicloergometry trainingOther
No Cicloergometry trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group held two months of training in hemodialysis a physical therapy protocol with cycle ergometer Receives: Other: Cicloergometry training |
| Control | Experimental | The control group was reassessed after two months of the initial evaluation Receives: Other: No Cicloergometry training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength evaluated by dynamometry
dynamometry
Measured: Two months
Peripheral blood tests
hemoglobin (g / dL)
Measured: Two months
Peripheral blood tests
serum albumin (GDL)
Measured: Two months
Peripheral blood tests
Creatinine (mg / dL)
Measured: Two months
Peripheral blood tests
Urea (mg / dL)
Measured: Two months
Peripheral blood tests
Kt / V
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2017
- Study completion30 Jan 2018
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 Chronic Renal DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Profa. Dra. Vera Lúcia dos Santos Alves, Faculdade de Ciências Médicas da Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834026
- Sponsor's protocol ID
- 1.398.846
- Status last verified
- Nov 2019
- First submitted
- 5 Jul 2016
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- 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 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Cycle Ergometer in Muscle Strength and Pulmonary Function in Patients in Hemodialysis
- ClinicalTrials.gov ID
- NCT02834026
- Acronym / sponsor ID
- 1.398.846
- Conditions
- Chronic Renal Disease, Renal Dialysis
- Keywords
- Muscle Strength, Muscle Strength Dynamometer, Chronic Renal Disease, Exercise, Physical therapy modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 15 Jul 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.
Muscle strength can be measured by dynamometry, but the investigators did not find in the literature the study of this technique in the quadriceps of patients with chronic kidney disease on hemodialysis. Analyze training impact conducted by cycle ergometer in quadriceps muscle strength in patients with chronic kidney disease during hemodialysis. This study will be a prospective, randomized. Inclusion of 46 patients followed by the dialysis unit of a university hospital, over 18 years, of both genders who underwent hemodialysis for more than six months and signed the consent form and enlightened. Patients will be divided into two groups: Intervention (n = 23) and control (n = 23). All will be evaluated for demographics and quadriceps strength given by standardization of technique, with hard and windy belt. The control group will be reassessed after two months of the initial assessment, since the intervention group held two months of training in hemodialysis a physical therapy protocol with the cycle ergometer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Cicloergometry trainingThe intervention group held two months of training in hemodialysis a physical therapy protocol with cycle ergometer |
| Control | Experimental | Other: No Cicloergometry trainingThe control group was reassessed after two months of the initial evaluation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged over 18 years
- Performing HD over six months
- Clinically stable
- Patients no diagnosis of lung disease
- Neurological or mioarticular previous or current and agreed to participate in the study and signed informed consent and informed
Key exclusion criteria (4 listed)
- Patients undergoing elective surgery or emergency six months before or during the performance of the protocol
- Cardiac decompensation
- Used continuous or nocturnal oxygen
- Patients using bracing of the lower limbs.
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 |
|---|---|---|
| Cicloergometry training | Other | Intervention |
| No Cicloergometry training | Other | Control |
Primary outcome
Muscle strength evaluated by dynamometry
Time frame: Two months
dynamometry
Peripheral blood tests
Time frame: Two months
hemoglobin (g / dL)
Peripheral blood tests
Time frame: Two months
serum albumin (GDL)
Peripheral blood tests
Time frame: Two months
Creatinine (mg / dL)
Peripheral blood tests
Time frame: Two months
Urea (mg / dL)
Peripheral blood tests
Time frame: Two months
Kt / V
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 2 Dec 2019.
- 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.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cicloergometry training and No Cicloergometry training in people with Chronic Renal Disease and Renal Dialysis, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo 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 5 inclusion and 4 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 2 Dec 2019. 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?
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?
Muscle strength evaluated by dynamometry (time frame: Two months). The study lists 6 primary outcomes in all. 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 NCT02834026, 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 2 Dec 2019.