Effects of Home-based or Center-based Aerobic Exercise in Patients With Chronic Kidney Disease (HBCKD)
24. marts 2015 opdateret af: Lilian Cuppari, Federal University of São Paulo
Effects of Home-based or Center-based Aerobic Exercise on Physical Function, Nutritional Status Ans Cardiopulmonary Parameters in Patients With Chronic Kidney Disease
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
45
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
30 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: sedentary control
|
|
|
Eksperimentel: 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.
|
|
|
Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cardiopulmonary capacity
Tidsramme: 24 weeks
|
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.
|
24 weeks
|
|
Functional capacity (walk, sit-stand, arm curl, sit-reach, back scratch, timed up and go)
Tidsramme: 24 weeks
|
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).
|
24 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of life
Tidsramme: 24 weeks
|
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.
|
24 weeks
|
|
sleep quality (PSQI)
Tidsramme: 24 weeks
|
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.
|
24 weeks
|
|
blood pressure
Tidsramme: 24 weeks
|
Blood pressure and resting heart rate were measured before the cardiopulmonary exercise test.
|
24 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Lilian Cuppari, PhD, Federal University of São Paulo
- Ledende efterforsker: Danilo T Aoike, MSc, Federal University of São Paulo
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2009
Primær færdiggørelse (Faktiske)
1. februar 2013
Studieafslutning (Faktiske)
1. marts 2013
Datoer for studieregistrering
Først indsendt
11. februar 2015
Først indsendt, der opfyldte QC-kriterier
4. marts 2015
Først opslået (Skøn)
5. marts 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. marts 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. marts 2015
Sidst verificeret
1. marts 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2009/14786-0
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