The Effects of Acute Resistance Exercise on Protein and Amino Acid Metabolism in Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Change in net whole-body protein synthesis
研究概览
简要总结
For this study a resistance bout will be performed in order to promote the robust response of protein synthesis. Type II muscle fibers often exhibit more atrophy than type I fibers in COPD subjects therefore specifically targeting them in an exercise protocol could have more beneficial outcome for these individuals.
详细描述
In this study, the following hypothesis will be tested: A bout of resistance exercise will affect the acute and 24h response in whole-body protein and amino acid metabolism and cognitive function as compared to baseline values in COPD patients and healthy subjects. To do this, subjects will complete a baseline visit in which they receive stable amino acid tracers. The next day they will complete a one-time resistance exercise with an immediate measurement of the amino acid tracers, and return 24 hours after exercise to repeat amino acid tracer measurements. This project will provide important clinical information on the whole body protein and amino acid metabolic response to acute resistance exercise in elderly subjects with COPD, as well as, the exercise induced changes in physical and cognitive function, and absolute muscular strength capacity in this population. In this way, this study will provide preliminary data for the development of standardized, repeatable resistance exercise protocols that will stop the process of ongoing muscle loss and improve metabolism and function in COPD subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •COPD subjects:
- •Ability to walk, sit down and stand up independently
- •Age 45 years or older
- •Ability to lie in supine or elevated position for 4 hours
- •Diagnosis of moderate to very severe chronic airflow limitation and compliant to the following criteria: FEV1 < 70% of reference FEV1
- •Clinically stable condition and not suffering from a respiratory tract infection or exacerbation of their disease (defined as a combination of increased cough, sputum purulence, shortness of breath, systemic symptoms such as fever, and a decrease in FEV1 > 10% compared with values when clinically stable in the preceding year) at least 4 weeks prior to the first test day
- •Shortness of breath on exertion
- •Willingness and ability to comply with the protocol
- •Inclusion criteria healthy subjects:
- •Healthy male or female according to the investigator's or appointed staff's judgment
- •Ability to walk, sit down and stand up independently
- •Age 45 years or older
- •Ability to lay in supine or elevated position for 4 hours
- •No diagnosis of COPD
- •Willingness and ability to comply with the protocol
排除标准
- •all subjects:
- •Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)
- •Established diagnosis of malignancy
- •History of untreated metabolic diseases including hepatic or renal disorder
- •Presence of acute illness or metabolically unstable chronic illness
- •Presence of fever within the last 3 days
- •Body mass index >40 kg/m2 (healthy subjects only)
- •Any other condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient
- •Use of protein or amino acid containing nutritional supplements within 5 days of first study day
- •Previous injury that could interfere with participation in resistance exercise protocol
- •Use of short course of oral corticosteroids within 4 weeks preceding first study day
- •Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- •(Possible) pregnancy
- •Already enrolled in another clinical trial and that clinical trial interferes with participating in this study
研究组 & 干预措施
Chronic Obstructive Pulmonary Disorder
screening visit: body weight and composition by DXA, height, and vital signs will be assessed.
study day(s): may include combinations of stable isotope infusions with blood draws, acute exercise, cognition testing
干预措施: stable amino acid infusion (Other)
Chronic Obstructive Pulmonary Disorder
screening visit: body weight and composition by DXA, height, and vital signs will be assessed.
study day(s): may include combinations of stable isotope infusions with blood draws, acute exercise, cognition testing
干预措施: acute exercise with amino acid infusion (Other)
Healthy
screening visit: body weight and composition by DXA, height, and vital signs will be assessed.
study day(s): may include combinations of stable isotope infusions with blood draws, acute exercise, cognition testing
干预措施: 24-hour post exercise amino acid infusion (Other)
Healthy
screening visit: body weight and composition by DXA, height, and vital signs will be assessed.
study day(s): may include combinations of stable isotope infusions with blood draws, acute exercise, cognition testing
干预措施: stable amino acid infusion (Other)
Healthy
screening visit: body weight and composition by DXA, height, and vital signs will be assessed.
study day(s): may include combinations of stable isotope infusions with blood draws, acute exercise, cognition testing
干预措施: acute exercise with amino acid infusion (Other)
Chronic Obstructive Pulmonary Disorder
screening visit: body weight and composition by DXA, height, and vital signs will be assessed.
study day(s): may include combinations of stable isotope infusions with blood draws, acute exercise, cognition testing
干预措施: 24-hour post exercise amino acid infusion (Other)
结局指标
主要结局
Change in net whole-body protein synthesis
时间窗: 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
Change in whole-body protein synthesis rate
次要结局
- taurine related metabolism(2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes)
- Body Composition(15 minutes on screening or study day 1)
- arginine related metabolism(2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes)
- Group differences in activity as measured by Physical Activity Scale for the Elderly (PASE)(study day 1)
- glutamate related metabolism(2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes)
- 24 hour diet recall(study day 1)
- appetite questionnaire(study day 1)
- tryptophan related metabolism(2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes)
- leucine related metabolism(2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes)
- changes in skeletal muscle fatigue(on study day 1 and change from day 2 and day 3)
- Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT)(on study day 1 and change from day 2 and day 3)
- Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS)(1 day)
- Group differences in learning and memory as measured by Digit Span(on study day 1 and change from day 2 and day 3)
- Group differences in attention and executive functions as measured by Digit Symbol Modalities Test(on study day 1 and change from day 2 and day 3)
研究者
Marielle PKJ Engelen, PhD
PhD
Texas A&M University