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CompletedNCT02834026Updated Dec 2, 2019

Impact of the Cycle Ergometer in Muscle Strength and Pulmonary Function in Patients in Hemodialysis

An interventional study of Cicloergometry training and No Cicloergometry training in Chronic Renal Disease and Renal Dialysis, sponsored by Faculdade de Ciências Médicas da Santa Casa de São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-02.

Sponsored by Faculdade de Ciências Médicas da Santa Casa de São Paulo · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jan 2016, registered Jul 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Renal Disease
  • Renal Dialysis

Keywords

  • Muscle Strength
  • Muscle Strength Dynamometer
  • Chronic Renal Disease
  • Exercise
  • Physical therapy modalities
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 46 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo is the lead sponsor of 39 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Intervention

    The intervention group held two months of training in hemodialysis a physical therapy protocol with cycle ergometer

    Other: Cicloergometry training

  • Experimental
    Control

    The control group was reassessed after two months of the initial evaluation

    Other: No Cicloergometry training

Interventions

  • OtherCicloergometry training
  • OtherNo Cicloergometry training
06

What researchers measure

Primary outcomes

  1. Muscle strength evaluated by dynamometry

    dynamometry

    Time frame: Two months

  2. Peripheral blood tests

    hemoglobin (g / dL)

    Time frame: Two months

  3. Peripheral blood tests

    serum albumin (GDL)

    Time frame: Two months

  4. Peripheral blood tests

    Creatinine (mg / dL)

    Time frame: Two months

  5. Peripheral blood tests

    Urea (mg / dL)

    Time frame: Two months

  6. Peripheral blood tests

    Kt / V

    Time frame: Two months

07

Study locations

1 site
  • Vera Lúcia dos Santos Alves
    São Paulo, SP, Brazil
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02834026
Lead sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Responsible party
Profa. Dra. Vera Lúcia dos Santos Alves (PHD, Faculdade de Ciências Médicas da Santa Casa de São Paulo) — Principal investigator
First posted
Jul 15, 2016
Start date
Jan 2016
Primary completion
Jun 2017
Completion
Jan 30, 2018
Last update
Dec 2, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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