Comparison of Exercise Capacity, Muscle Strength and Oxygenation, Arterial Stiffness, Physical Activity and Quality of Life in Individuals with Chronic Obstructive Pulmonary Disease and Impaired Spirometry with Preserved Ratio
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Muscle Oxygenation
研究概览
简要总结
Despite the globally varying high prevalence rate of the PRISm phenotype, there are no guidelines for its diagnostic evaluation and management. Further studies are needed on appropriate approaches for individuals with PRISm to improve respiratory symptoms and prognosis. As research continues to evolve, PRISm needs to be recognized as a critical component of pulmonary assessments and at-risk individuals need to be provided with appropriate treatment and follow-up to prevent progression to COPD. There are no studies in the literature comparing PRISm, respiratory muscle strength, peripheral muscle strength and oxygenation, arterial stiffness, physical activity level and sleep level in COPD and healthy individuals. The aim of this study was to compare respiratory muscle strength, peripheral muscle strength and oxygenation, arterial stiffness, physical activity level and sleep level in PRISm, COPD and healthy subjects.
详细描述
Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable multisystemic lung disease characterised by chronic respiratory symptoms (dyspnoea, cough, expectoration and/or exacerbations) due to abnormalities in the airways causing permanent and often progressive airflow limitation. In a part of the individuals with affected lung function, FEV1/FVC is preserved after bronchodilation (≥ 70%), whereas FEV1 is lower than expected (< 80%). This condition, which describes a preserved ratio impaired spirometry (PRISm), is highly prevalent in current and former smokers. PRISm is defined as a spirometry pattern that is not always a stable phenotype, but should be considered ''patient'' because symptoms and/or functional and/or structural abnormalities are present and therefore require care and treatment. There are studies showing that pulmonary functions, exercise capacity and quality of life are impaired in individuals with PRISm, whose pathophysiology is unclear and clinical effects are not known. In addition to the insufficient number of studies investigating exercise capacity, quality of life and pulmonary function on behalf of PRISm in the literature, no previous studies comparing respiratory muscle strength, peripheral muscle strength and oxygenation, arterial stiffness, physical activity level and sleep level in PRISm, COPD and healthy individuals have been found. In this study, aimed to investigate whether the parameters (symptoms, respiratory and peripheral muscle strength, physical activity level, exercise capacity, muscle oxygenation, arterial stiffness), which have been proven to be affected in the COPD group due to their clinical similarity with COPD, are affected in the PRISm group. A total of 54 individuals, 18 in each group, will be included in the study. Pulmonary function, symptoms, body composition, respiratory muscle strength, peripheral muscle strength, exercise capacity, tissue oxygenation, arterial stiffness, physical activity levels, sleep and quality of life will be compared in PRISm, COPD and healthy individuals. Our study will be able to reveal the clinical status of PRISM patients in terms of pulmonary function, symptoms, body composition, respiratory muscle strength, peripheral muscle strength, exercise capacity, tissue oxygenation, arterial stiffness, physical activity levels, sleep and quality of life compared to COPD group and healthy group and will be a guide in planning pulmonary rehabilitation programmes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PRISm group inclusion criteria;
- •Being >40 years old,
- •Being diagnosed with PRISm,
- •Volunteering to participate in the study,
- •Not having any orthopaedic or neurological problems that may prevent participation in the measurements,
- •Co-operation with measurements
- •Inclusion criteria for the COPD group;
- •Being >40 years old,
- •Being diagnosed with COPD,
- •To be clinically stable,
- •Volunteering to participate in the study.
- •Inclusion criteria for healthy individuals;
- •Being >40 years old,
- •Volunteering to participate in the study,
- •No known chronic health problems,
- •To be able to co-operate with the measurements.
排除标准
- •PRISm group exclusion criteria;
- •Being diagnosed with COPD,
- •Severe orthopaedic, neurological and cardiac diseases
- •Not volunteering to participate in the study
- •Exclusion criteria for COPD group;
- •Severe orthopaedic, neurological and cardiac diseases,
- •Being in COPD exacerbation period,
- •Not volunteering to participate in the study.
- •Healthy individuals exclusion criteria;
- •Having a known chronic disease,
- •Not volunteering to participate in the study
结局指标
主要结局
Muscle Oxygenation
时间窗: 10 minutes
Muscle oxygenation is assessed using a measurement and monitoring device (Moxy Fortiori Design LLC, Minnesota, USA). The device is placed on the vastus lateralis muscle. Resting measurements are taken for at least 3 minutes until the muscle oxygen saturation (SmO2) signal stabilizes. SmO2 at rest, SmO2 during 6DYT and during the first minute of recovery, and mean SmO2 are recorded.
Physical Activity
时间窗: 5 minutes
Physical activity levels is assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The IPAQ requires respondents to estimate time spent in various levels of physical activity during the previous week. Scores for walking and moderate and vigorous activities are calculated as durations and frequencies multiplied by known metabolic equivalents per activity. The results for all activity-based items are summed for the total physical activity score. The participants were then categorized as inactive, minimally active and sufficiently active according to the IPAQ categorical classification.
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.
Arterial Stiffness
时间窗: 20 minutes
Arterial stiffness is evaluated with a Tel-O-Graph CT device with oscillometric cuff (I.E.M., Stolberg, Germany). Central systolic blood pressure, pulse wave velocity (PWV) and augmentation index (Alx) are measured with brachial pulse waves. After a five-minute rest, three measurements are performed in a quiet environment.
次要结局
- Body Composition(5 minutes)
- Respiratory Muscle Strength(10 minutes)
- Peripheral Muscle Strength(5 minutes)
- Sleep Quality(5 minutes)
- COPD Assessment Test(5 minutes)
- Quality of Life(10 minutes)
- Symptoms(8 minutes)
- Pulmonary Function Test (forced vital capacity (FVC))(10 minutes)
- Pulmonary Function Test (forced expiratory volume in the first second (FEV1))(10 minutes)
- Pulmonary Function Test (FEV1/FVC)(10 minutes)
- Pulmonary Function Test (peak flow rate (PEF))(10 minutes)
- Pulmonary Function Test (forced expiratory flow from 25-75% (FEF25-75%))(10 minutes)
研究者
Ece Kumlu
Principal Investigator
Hacettepe University