A Comparison of Exercise Capacity, Arterial Stiffness, and Cognitive Function Between Adults With Cystic Fibrosis and Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Exercise capacity
研究概览
简要总结
No studies in the literature have investigated the simultaneous effects of cognitive function, exercise capacity and arterial stiffness in adult patients with CF. The study aims to compare the cognitive function, exercise capacity, exercise muscle oxygenation, and arterial stiffness of adult patients with CF and healthy subjects.
详细描述
Cystic fibrosis (CF) affects other body systems as well as the respiratory system. Patients with CF seem to have reduced exercise capacity, which is a major contributor to mortality rates. Changes in lung function, ventilatory dysfunction, and respiratory muscle function potentially contribute to exercise intolerance in CF. Both children and adults with CF exhibit neurocognitive dysfunction. Arterial stiffness is a predictor of cardiovascular events, including myocardial infarction, heart failure, and mortality. Individuals with CF exhibit an increase in arterial stiffness. However, no studies in the literature have investigated cognitive function, exercise capacity, and arterial stiffness coexistence in adult CF patients. The study aims to compare the cognitive function, exercise capacity, exercise muscle oxygenation and arterial stiffness in adult patients with CF and healthy subjects. Additionally, it will determine the relationship between cognitive function and arterial stiffness with exercise capacity and muscle oxygenation during exercise in adult patients with CF.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having been diagnosed with cystic fibrosis
- •Being 18 years old and older
- •Clinically stable condition
- •Able to cooperate with the tests performed
- •Volunteered to participate in the study
- •For the control group:
- •Being 18 years old and older
- •Volunteered to participate in the study
排除标准
- •History of hospitalization or exacerbation in the last month.
- •Chronic respiratory failure and long-term use of oxygen therapy
- •Using noninvasive mechanical ventilator therapy
- •Indication for lung transplantation
- •Who had a lung transplant
- •Forced expiratory volume in the first second (FEV1) value 30% and below
- •CF-related diabetes
- •Chronic liver disease
- •Allergic bronchopulmonary aspergillosis
- •Systemic steroid use
- •History of diagnosed orthopedic or musculoskeletal problems affecting mobility
- •Cardiovascular instability
- •Serious psychiatric illness
- •For the control group:
- •Known chronic or systemic disease
- •Who did not volunteer to participate in the study
结局指标
主要结局
Exercise capacity
时间窗: 6 minutes
Exercise capacity is assessed using the 6-minute walk test (6MWT). The 6MWT is performed according to the criteria of the American Thoracic Society.
Muscle Oxygenation Assessment
时间窗: 10 minutes
Muscle oxygenation (SmO2) is assessed using a measuring and monitoring device (Moxy Fortiori Desing LLC, Minnesota, USA).
Cognitive Assessment- MoCA
时间窗: 10 minutes
Cognitive function is measured using the Montreal Cognitive Assessment (MoCA) test. The MoCA test is a questionnaire developed to evaluate different cognitive functions and mild cognitive impairment. The maximum score that an individual can obtain from the test is 30, and a score of 26 above is considered as mild cognitive impairment.
Arterial Stiffness Assessment
时间窗: 20 minutes
Arterial stiffness is determined using a oscillometric cuff device (Tel-O-Graph BT, I.E.M., Stolberg, Germany). Pulse wave velocity (PWV) and augmentation index (AIx) are measured by brachial pulse waves.
Cognitive Assessment-Mini Mental Test
时间窗: 10 minutes
Cognitive function is measured using the Mini Mental Test. A higher score indicates better cognitive function. The maximum score that an individual can obtain from the test is 30, and a score of 23 and above is considered as cognitive impairment.
次要结局
- Respiratory Muscle Strength(10 minutes)
- Peripheral Muscle Strength(5 minutes)
- Body Composition(5 minutes)
- Physical Activity Assessment(5 minutes)
- Sleep Quality(5 minutes)
- Pulmonary Function Test (forced expiratory volume in the first second (FEV1))(10 minutes)
- Pulmonary Function Test (peak flow rate (PEF))(10 minutes)
- Pulmonary Function Test (forced vital capacity (FVC))(10 minutes)
- Pulmonary Function Test (FEV1/FVC)(10 minutes)
- Pulmonary Function Test (forced expiratory flow from 25-75% (FEF25-75%))(10 minutes)
- Anxiety and Depression(5 minutes)
- General Health-Related Quality of Life(5 minutes)
- Disease Specific Quality of Life(8 minutes)
研究者
Deniz Inal-Ince
Professor
Hacettepe University