CClinicalTrials.gg
CompletedNCT02379533HBCKDUpdated Mar 26, 2015

Effects of Home-based or Center-based Aerobic Exercise in Patients With Chronic Kidney Disease

An interventional study of Aerobic exercise in Chronic Renal Failure and Obese, sponsored by Federal University of São Paulo. Completed. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-03-26.

Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
All
01

Study summary

Patients will be randomly assigned to perform the training program in center or home-based . The training program will be conducted in accordance with the recommendations of the American College of Sports Medicine. All training sessions will be preceded by stretching of large muscle groups and heating (5 minutes) and at the end by cool down and stretching (5 minutes). The program will consist of 24 weeks with three sessions per week on alternate days. The aerobic training will be continuous, with an increment of 10 minutes in duration every 4 weeks. The intensity will be prescribed according to ventilatory threshold, characterized by the highest intensity of physical exertion fully maintained by aerobic energy pathways. The intensity control was done by means of the heart rate value obtained at ventilatory threshold.

Both groups receive the same intervention. However, a group exercise held in the center on a treadmill with the direct supervision of a physical education teacher. The other group will exercise at home with telephone follow-up weekly and once a month will be held at the training center under the supervision of a physical education teacher.

It will also constituted a control group remain without performing any activity during the study period. After 24 weeks patients receive the same advice the team conducting the training at home.

02

Conditions studied

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 45 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

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

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Sedentary individuals with chronic kidney disease stages 3 or 4 disease;
  • Both genders;
  • Age between 30 and 65 years;
  • Overweight (BMI> 25 kg/m2);
  • With a negative stress test.

Exclusion criteria

Exclusion Criteria:

  • Patients with chronic obstructive pulmonary disease,
  • class IV heart failure,
  • myocardial infarction within the last 6 months,
  • decompensated hypertension (systolic blood pressure> 180 mmHg or diastolic> 110 mmHg in the last 6 months),
  • uncontrolled cardiac arrhythmia,
  • decompensated diabetes mellitus (glycated hemoglobin> 8.0%),
  • unstable angina,
  • infectious processes in the last 3 weeks;
  • begin use of erythropoietin or with hemoglobin \<11g/L.
  • use of beta-blocker medication
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • No intervention
    sedentary control
  • Experimental
    Home-based aerobic exercise

    The training program will be conducted in accordance with the recommendations of the American College of Sports Medicine. All training sessions will be preceded by stretching of large muscle groups and heating (5 minutes) and at the end by cool down and stretching (5 minutes). The program will consist of 24 weeks with three sessions per week on alternate days. The aerobic training will be continuous, with an increment of 10 minutes in duration every 4 weeks. The intensity will be prescribed according to ventilatory threshold, characterized by the highest intensity of physical exertion fully maintained by aerobic energy pathways. The intensity control was done by means of the heart rate value obtained at ventilatory threshold. The home-based exercise group exercise at home with telephone follow-up weekly and once a month will be held at the training center under the supervision of a physical education teacher.

    Other: Aerobic exercise

  • Active comparator
    Center-based aerobic exercise

    The training program will be conducted in accordance with the recommendations of the American College of Sports Medicine. All training sessions will be preceded by stretching of large muscle groups and heating (5 minutes) and at the end by cool down and stretching (5 minutes). The program will consist of 24 weeks with three sessions per week on alternate days. The aerobic training will be continuous, with an increment of 10 minutes in duration every 4 weeks. The intensity will be prescribed according to ventilatory threshold, characterized by the highest intensity of physical exertion fully maintained by aerobic energy pathways. The intensity control was done by means of the heart rate value obtained at ventilatory threshold. However, a group exercise held in the center on a treadmill with the direct supervision of a physical education teacher.

    Other: Aerobic exercise

Interventions

  • OtherAerobic exercise
06

What researchers measure

Primary outcomes

  1. Cardiopulmonary capacity

    The test began with a fixed inclination of 1%. The initial velocity was 2 km/h during the first three minutes with increments of 0.5km/h every minute until the patient reaches physical exhaustion. The ventilatory variables were measured using a gas analyzer. The highest oxygen uptake obtained during the last stage reached was considered the peak oxygen uptake. The ventilatory threshold was determined as the stage preceding the first occurrence of the exponential increase in ventilation, increase in the ventilatory equivalent for oxygen and increase in expired fraction of oxygen. The respiratory compensation point was determined as the stage preceding the second occurrence of the exponential increase in ventilation, increase in the ventilatory equivalent for carbon dioxide and decrease in end-tidal carbon dioxide. Data were analyzed by the average of 20 seconds.

    Time frame: 24 weeks

  2. Functional capacity (walk, sit-stand, arm curl, sit-reach, back scratch, timed up and go)

    Functional capacity was assessed using a variety of objective measures. These included six-minute walk test (maximal distance walked along an internal corridor during six minutes), two-minute step test (maximal number of steps achieved in stationary walking during two minutes, used to quantifying the aerobic power), sit-to-stand test (maximal sit to stand cycles achieved in 30 seconds, used to quantifying the muscular endurance of the legs), arm curl test (maximal number of arm curl cycles in 30 seconds, used to quantifying the muscular endurance of the arms), sit and reach test (maximal distance achieved in the Wells bench, used to quantifying the general flexibility), back scratch test (maximum amplitude of the arms used to quantifying the arms flexibility) and time up and go test (shorter time to rise from a chair, walk three meters and sit back, used to quantifying the functional mobility).

    Time frame: 24 weeks

Secondary outcomes

  1. Quality of life

    The Short-Form Health Survey (SF-36) questionnaire was applied to assess the quality of life. The scores for each domain range from 0 to 100%. The higher scores define a better quality of life. The questionnaire was applied individually in a clear and quiet room with the patient rested.

    Time frame: 24 weeks

  2. sleep quality (PSQI)

    The PSQI assesses the quality of sleep for the last month of the interview. The questionnaire has 19 questions that comprise seven assessment components: quality of sleep, latency, duration, efficiency, nocturnal sleep disturbances, use of sleep medication and daytime sleepiness. Each component receives a score from 0 to 3, in a way that the final score can range between 0 and 21. The higher the score, the worse the quality of sleep, and scores higher than five indicate sleep disturbances.

    Time frame: 24 weeks

  3. blood pressure

    Blood pressure and resting heart rate were measured before the cardiopulmonary exercise test.

    Time frame: 24 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Conley MM, McFarlane CM, Johnson DW, Kelly JT, Campbell KL, MacLaughlin HL. Interventions for weight loss in people with chronic kidney disease who are overweight or obese. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD013119. doi: 10.1002/14651858.CD013119.pub2. PubMed 33782940 ↗
  • Gomes TS, Aoike DT, Baria F, Graciolli FG, Moyses RMA, Cuppari L. Effect of Aerobic Exercise on Markers of Bone Metabolism of Overweight and Obese Patients With Chronic Kidney Disease. J Ren Nutr. 2017 Sep;27(5):364-371. doi: 10.1053/j.jrn.2017.04.009. Epub 2017 Jun 9. PubMed 28606422 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02379533
Lead sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Responsible party
Lilian Cuppari (PhD, Affiliate Professor, Federal University of São Paulo) — Principal investigator
First posted
Mar 5, 2015
Start date
Aug 2009
Primary completion
Feb 2013
Completion
Mar 2013
Last update
Mar 26, 2015

Study contacts

Lilian Cuppari, PhD
principal investigator · Federal University of São Paulo
Danilo T Aoike, MSc
principal investigator · Federal University of São Paulo

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion