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

Primary Purpose

Chronic Renal Failure, Obese

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aerobic exercise
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Renal Failure

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Active Comparator

    Arm Label

    sedentary control

    Home-based aerobic exercise

    Center-based aerobic exercise

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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).

    Secondary Outcome Measures

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

    Full Information

    First Posted
    February 11, 2015
    Last Updated
    March 24, 2015
    Sponsor
    Federal University of São Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02379533
    Brief Title
    Effects of Home-based or Center-based Aerobic Exercise in Patients With Chronic Kidney Disease
    Acronym
    HBCKD
    Official Title
    Effects of Home-based or Center-based Aerobic Exercise on Physical Function, Nutritional Status Ans Cardiopulmonary Parameters in Patients With Chronic Kidney Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2009 (undefined)
    Primary Completion Date
    February 2013 (Actual)
    Study Completion Date
    March 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of São Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Renal Failure, Obese

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    sedentary control
    Arm Type
    No Intervention
    Arm Title
    Home-based aerobic exercise
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Center-based aerobic exercise
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Aerobic exercise
    Primary Outcome Measure Information:
    Title
    Cardiopulmonary capacity
    Description
    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
    Title
    Functional capacity (walk, sit-stand, arm curl, sit-reach, back scratch, timed up and go)
    Description
    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 Outcome Measure Information:
    Title
    Quality of life
    Description
    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
    Title
    sleep quality (PSQI)
    Description
    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
    Title
    blood pressure
    Description
    Blood pressure and resting heart rate were measured before the cardiopulmonary exercise test.
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lilian Cuppari, PhD
    Organizational Affiliation
    Federal University of São Paulo
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Danilo T Aoike, MSc
    Organizational Affiliation
    Federal University of São Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33782940
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    28606422
    Citation
    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.
    Results Reference
    derived

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

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