Effects of Home-based or Center-based Aerobic Exercise in Patients With Chronic Kidney Disease (HBCKD)
24 de março de 2015 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
45
Estágio
- Não aplicável
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
30 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: 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.
|
|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cardiopulmonary capacity
Prazo: 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)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quality of life
Prazo: 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)
Prazo: 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
Prazo: 24 weeks
|
Blood pressure and resting heart rate were measured before the cardiopulmonary exercise test.
|
24 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lilian Cuppari, PhD, Federal University of São Paulo
- Investigador principal: Danilo T Aoike, MSc, Federal University of São Paulo
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de agosto de 2009
Conclusão Primária (Real)
1 de fevereiro de 2013
Conclusão do estudo (Real)
1 de março de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
11 de fevereiro de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de março de 2015
Primeira postagem (Estimativa)
5 de março de 2015
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
26 de março de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de março de 2015
Última verificação
1 de março de 2015
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2009/14786-0
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