- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00825903
The Effects of Exercise on Physiological and Psychological Parameters in an Asthmatic Population
Visão geral do estudo
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
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Washington
-
Pullman, Washington, Estados Unidos, 99164
- Washington State University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
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
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
Patrocinador
Investigadores
- Investigador principal: Kasee J Hildenbrand, PhD, Washington State University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 10460
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 .