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Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation

9 de fevereiro de 2012 atualizado por: Professor Richard Costello, Beaumont Hospital

Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation: 1 Year Follow-up

Sustained improvement after pulmonary rehabilitation in activity levels as measured by an activity armband.

Pulmonary rehabilitation is utilized to improve exercise capacity, quality of life and prognosis for patients who suffer from chronic obstructive pulmonary disease. There is also strong evidence that supports the use of pulmonary rehabilitation to decrease hospital admissions thereby reducing cost of care. Recent studies suggest that the significant benefits achieved through rehabilitation fade with time and that in order to improve activities of daily living; for example, average daily number of steps, programmes of longer duration are required.

The primary aim of this study is to identify objective sustained improved in activity levels using the SenseWear activity armband after a short-term pulmonary rehabilitation programme. Secondary aims are to determine antibiotic and steroid use pre and post rehabilitation.

Visão geral do estudo

Status

Concluído

Intervenção / Tratamento

Descrição detalhada

Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation and by both systemic and airway inflammation. Together these features lead to decreased physical activity which in turn worsens the patient's dyspnoea. In patients with COPD, physical activity levels are low compared to healthy controls and indeed lower than in patients with other chronic conditions such as arthritis and diabetes. For patients with COPD, decreased physical activity and breathlessness are significant predictors of mortality and morbidity. By reversing deconditioning pulmonary rehabilitation using supervised and home exercise programs leads to increased exercise capacity and health quality of life scores. In order for the benefits of pulmonary rehabilitation to be sustained in the long-term it is essential that there is a change in the patient's physical activity in their home life. While practice guidelines recommend that there is transference of exercise to the home setting it is unknown if this happens in reality. Addressing whether there is an increase in physical activity at home after pulmonary rehabilitation is the focus of this study.

Physical activity can be measured in a number of ways, including direct observation, patient diaries and questionnaires, but one of the most successful are the performance based motion sensors such as pedometers and accelerometers. One such performance based motion sensor is the SenseWear accelerometer. The SenseWear has previously been used in patients with COPD, has been shown to be a reliable measure of physical activity performed in this population, other than those using rolators and it is objectively more accurate than questionnaires and diaries. The hypothesis of this study was that pulmonary rehabilitation leads to a sustained improvement in physical activity in patients with COPD. Physical activity was measured by the daily averaged activity recorded with a SenseWear armband at several time points in the year after a course of pulmonary rehabilitation.

Tipo de estudo

Intervencional

Inscrição (Real)

65

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Dublin
      • Beaumont, Dublin, Irlanda, 9
        • Beaumont Hospital

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

35 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • A diagnosis of COPD based on the GOLD staging of the disease
  • Referred to pulmonary rehabilitation by a respiratory consultant or member of the COPD Team
  • Modified Medical Research Council Score of 3 or above
  • Ability to mobilize independently
  • Motivated to exercise independently

Exclusion Criteria:

  • No evidence of COPD on spirometry
  • Acute exacerbation within the last 4-6 weeks
  • Evidence of ischemic heart disease/acute changes on ECG
  • Uncontrolled hypertension
  • Insulin dependent diabetes mellitus
  • Inability to exercise independently or musculoskeletal/neurological conditions which would prevent completion of the course
  • Lung cancer previous attendance at pulmonary rehabilitation

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: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Control Group
Patients are randomized to the control group and are assessed pre rehabilitation and post rehabilitation after which they proceed to the intervention group.
Experimental: Pulmonary Rehabilitation
Patients undergo an active seven week pulmonary rehabilitation programme. Assessments occur pre rehabilitation, post rehabilitation, at three months and at one year.
Patients undergo pulmonary rehabilitation for two hours twice a week for seven weeks. The first hour comprises of an individualized exercise programme and the second hour consists of an educational component. Patients are also required to undergo inspiratory muscle training five days a week for thirty minutes and exercise for an additional three days a week for thirty minutes.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Sustained improvement in free-living activities, measured as the average daily METs
Prazo: At the end of 1 year compared to baseline
Using an accelerometer, which will be worn by patients for seven consecutive days at each time frame, daily average measurements of the number of steps per day, total energy expenditure and METs that will be broken down into sedentary, moderate and vigorous, plus sleep time and efficiency.
At the end of 1 year compared to baseline

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Quality of Life
Prazo: baseline will be compared to that at 1 year follow-up
Two quality of life questionnaires will be utilized, 1) the St. Georges Disease Questionnaire; a disease specific questionnaire, 2)The generic EuroQol questionnaire
baseline will be compared to that at 1 year follow-up
The Incremental Shuttle Walk Test
Prazo: baseline will be compared to that at 1 year follow-up
This is a validated field exercise test used to prescribe exercise intensity and determine functional capacity
baseline will be compared to that at 1 year follow-up
The Modified Medical Research Council Scale
Prazo: baseline will be compared to that at 1 year follow-up
This questionnaire measures breathlessness on activity
baseline will be compared to that at 1 year follow-up
Pulmonary Function Tests
Prazo: baseline will be compared to that at 1 year follow-up
Measurements of forced expiratory volume in 1 second, Forced Vital Capacity, Inspiratory Capacity and peak inspiratory muscle pressure will all be measured
baseline will be compared to that at 1 year follow-up
Borg Score
Prazo: baseline will be compared to that at 1 year follow-up
A 10 point scale measurement of breathlessness
baseline will be compared to that at 1 year follow-up

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Cadeira de estudo: Richard W Costello, Professor, Beaumont Hospital
  • Investigador principal: Brenda M Deering, MSc Physio, Beaumont Hospital
  • Investigador principal: Claire Egan, MSc Physio, Beaumont Hospital
  • Investigador principal: Niamh M McCormack, MSc Nursing, Beaumont Hosptial

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 junho de 2007

Conclusão Primária (Real)

1 de julho de 2010

Conclusão do estudo (Real)

1 de julho de 2010

Datas de inscrição no estudo

Enviado pela primeira vez

18 de agosto de 2010

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de fevereiro de 2012

Primeira postagem (Estimativa)

10 de fevereiro de 2012

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

10 de fevereiro de 2012

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de fevereiro de 2012

Última verificação

1 de fevereiro de 2012

Mais Informações

Termos relacionados a este estudo

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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