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

24. März 2015 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

45

Phase

  • Unzutreffend

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

30 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: 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.
Sonstiges: Aerobic Übung
Aktiver 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.
Sonstiges: Aerobic Übung

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cardiopulmonary capacity
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Quality of life
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 24 weeks
Blood pressure and resting heart rate were measured before the cardiopulmonary exercise test.
24 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Federal University of São Paulo

Mitarbeiter

Fundação de Amparo à Pesquisa do Estado de São Paulo

Ermittler

  • Hauptermittler: Lilian Cuppari, PhD, Federal University of São Paulo
  • Hauptermittler: Danilo T Aoike, MSc, Federal University of São Paulo

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. August 2009

Primärer Abschluss (Tatsächlich)

1. Februar 2013

Studienabschluss (Tatsächlich)

1. März 2013

Studienanmeldedaten

Zuerst eingereicht

11. Februar 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. März 2015

Zuerst gepostet (Schätzen)

5. März 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

26. März 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. März 2015

Zuletzt verifiziert

1. März 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2009/14786-0

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