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The Effects of Exercise on Physiological and Psychological Parameters in an Asthmatic Population

31 de dezembro de 2011 atualizado por: Kasee Hildenbrand, Washington State University
Exercise has been shown to have extensive health benefits both in normally functioning adults as well as in adults with asthma. A program of regular aquatic exercise may have unique benefits in the asthmatic population because of the known aerobic capacity development typical of such programs, combined with the unique value of immersion-produced improvements in respiratory endurance and cardiac output. The purpose of this study is to explore the effects of a 12 week long aquatic endurance training program on several physiological and psychological parameters related to coronary heart disease and type II diabetes in an asthmatic population.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

The study will run from August 2008 to May 2009. Recruitment and screening of participants will occur from August to December 2008 for inclusion into the clinical trial. Prior to the clinical trial participants will have a one hour informational session to clearly present the study, obtain signed informed consent and set up fitness/blood appointments for data collection. Data collection will begin the first week of school in January. The 12-week exercise protocol will start the second week of school and continue through the middle of April. Research participants will not have any exercise session during spring break (March 16-20). Final data collection will occur during the last two weeks of school. Pre-treatment and post-treatment data collection will include a fitness assessment and blood draw. Medication usage for asthma will be monitored on a weekly basis thoughout the clinical trial. Physical activity will also be monitored monthly.

The screening session is a 30-minute session where research participants complete health/behavior questionnaires and a physiological measure of lung function. Information to be collected in the health/behavior questionnaires includes: demographic and behavioral/lifestyle variables (sex, race, age, smoking status, and medical history).

The fitness assessment will be 60 minutes in length. At the beginning of the session participants will complete a survey to assess state anxiety (State-Trait Anxiety Inventory - Trait version Form X-1; Spielberger, Gorsuch, & Lushene, 1970). Heart rate variability will be measured through the ventral placement of 3 electrodes placed on the subject's torso. The areas will be prepped by swabbing with alcohol and lightly scrubbing to remove dead skin. The electrodes will be held in place with a sticky disc and a strip of athletic tape. Heart rate and resting blood pressure will also be taken. Body composition will be assessed using the BodPod system. Research participants will sit in an enclosed capsule (bod pod) for three tests lasting approximately 40 seconds each. Lung function will be assessed using a spirometer to measure the maximal volume of air exhaled over a period of time after a maximal inhalation. To assess cardiorespiratory fitness research participants will complete a VO2 Max test. Participants will ride a bicycle ergometer for approximately 15-20 minutes moving through stages (including a 3 minute warm-up) with progressively higher resistance levels until maximum tolerance. After termination there is a cool-down/recovery period of approximately 3-4 minutes.

The blood draw session will take approximately 30 minutes and participants will be asked to fast (no food or drink) for 12 hours prior to blood draw. Upon check-in participants will complete a series of questionnaires assessing psychological variables stress (Perceived Stress Scale-14 item version Form X-1; Cohen, Kamarck & Mermelstein, 1983), depression (Center for Epidemiological Studies - Depression Scale; Radloff, 1977), and quality of life (Asthma Impact Survey; QualityMetric Health Outcomes Solutions, Lincoln, RI). The quality and quantity of sleep will also be assessed using the Pittsburgh Sleep Quality Index (Buysse, Reynolds, Monk, Berman, & Kupfer, 1989). Once questionnnaires are completed, participants will have their blood drawn by a certified phlebotomist. Three days after the blood draw particpants will be contacted by phone and questioned about current health status.

After the first week of pretreatment data collection, before the training sessions begin, research participants will undergo an explanation and training session to learn how to evaluate their own rate of perceived exertion (RPE). The water-based exercise programs are 3 times a week for 12 weeks. The exercise sessions will begin with a 10-minute warm up and end with a 5-minute cool down period. The conditioning portion of the exercise program will be shorter in duration with lower intensities at the beginning of the 12 weeks. There will be a progression to higher intensities for longer periods of time throughout the 12 weeks using recommendations from the American College of Sports Medicine. Exercise sessions will not exceed 50 minutes.

Tipo de estudo

Intervencional

Inscrição (Real)

16

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

    • Washington
      • Pullman, Washington, Estados Unidos, 99164
        • Washington State University

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

18 anos a 40 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Medically diagnosed and medication managed asthmatics between the ages of 18-40

Exclusion Criteria:

  • outside the age range of 18-40 years old, fear of water, diseases or conditions listed during screening process, or current smoker.

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: Não randomizado
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 1
Aquatic based exercise
Exercise 3 times each week for a total of 12 weeks. Each session is 50 min. in length.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Pulmonary Function
Prazo: baseline and 12 weeks post
baseline and 12 weeks post

Medidas de resultados secundários

Medida de resultado
Prazo
Histórico médico
Prazo: linha de base
linha de base
Demographic information
Prazo: baseline
baseline
Smoking practices
Prazo: baseline
baseline
Exercise practices
Prazo: baseline and monthly
baseline and monthly
State Anxiety
Prazo: baseline and 12 weeks post
baseline and 12 weeks post
Perceived Stress
Prazo: baseline and 12 weeks post
baseline and 12 weeks post
Depression
Prazo: baseline and 12 weeks post
baseline and 12 weeks post
Sleep - duration and quality
Prazo: baseline and 12 weeks post
baseline and 12 weeks post
Quality of Life as related to asthma
Prazo: baseline and 12 weeks post
baseline and 12 weeks post
Body composition
Prazo: baseline and 12 weeks post
baseline and 12 weeks post
Cardiovascular fitness level- VO2 max
Prazo: baseline and 12 weeks post
baseline and 12 weeks post
Resting Heart Rate
Prazo: baseline and 12 weeks post
baseline and 12 weeks post
Heart Rate Variability and ECG
Prazo: baseline and 12 weeks post
baseline and 12 weeks post
Serum cholesterol levels
Prazo: baseline and 12 weeks post
baseline and 12 weeks post
Fasting blood glucose
Prazo: baseline and 12 weeks post
baseline and 12 weeks post
Cortisol
Prazo: baseline and 12 weeks post
baseline and 12 weeks post
Insulin
Prazo: baseline and 12 weeks post
baseline and 12 weeks post
CRP
Prazo: baseline and 12 weeks post
baseline and 12 weeks post
Homocysteine
Prazo: baseline and 12 weeks post
baseline and 12 weeks post
Lipoprotein-Associated Phospholipase A2 (PLAC)
Prazo: baseline and 12 weeks post
baseline and 12 weeks post
Medication usage
Prazo: prior and throughout study
prior and throughout study
Exercise Adherence
Prazo: throughout study
throughout study
Resting blood pressure
Prazo: baseline and 12 weeks post
baseline and 12 weeks post

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Kasee J Hildenbrand, PhD, Washington State University

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 setembro de 2008

Conclusão Primária (Real)

1 de maio de 2009

Conclusão do estudo (Real)

1 de agosto de 2009

Datas de inscrição no estudo

Enviado pela primeira vez

16 de janeiro de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de janeiro de 2009

Primeira postagem (Estimativa)

21 de janeiro de 2009

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

4 de janeiro de 2012

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de dezembro de 2011

Última verificação

1 de dezembro de 2011

Mais Informações

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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