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临床试验/NCT07306468
NCT07306468招募中不适用

Investigation of Exercise Capacity, Pulmonary Function, Respiratory Muscle Strength, and Quality of Life in Patients Diagnosed With Schizophrenia and Bipolar Disorder

Çankırı Karatekin University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Maximum Inspiratory Pressure (MIP) measurement

研究概览

简要总结

This observational study aims to evaluate exercise capacity, pulmonary function, respiratory muscle strength, and quality of life in individuals diagnosed with schizophrenia and bipolar disorder. These psychiatric conditions are associated with sedentary lifestyles, metabolic side effects of psychotropic medications, and increased comorbidity risks, all of which may negatively impact physical fitness and respiratory health. By assessing cardiorespiratory endurance, pulmonary parameters (FVC, FEV₁), and respiratory muscle strength in this population, the study seeks to identify physiological limitations and contribute to the development of more effective rehabilitation strategies. The findings may support multidisciplinary approaches to improving physical health and overall quality of life in individuals with severe mental illness.

详细描述

Schizophrenia is a mental disorder observed in approximately 4 out of every 1,000 individuals in the general population, with a morbidity rate of 0.72%. According to the Global Burden of Disease Study (2010), around 20,000 deaths occur annually due to schizophrenia-related causes. Bipolar disorder is recognized as a chronic and severe mental illness. Based on data from the World Health Organization's global burden of disease reports, bipolar disorder ranks among the top 20 diseases contributing to disability worldwide and holds the 6th position among mental disorders.

Schizophrenia and bipolar disorder are serious and chronic psychiatric conditions affecting millions of individuals globally. The prevalence of schizophrenia is approximately 1%, while bipolar disorder has a lifetime prevalence of 2-3%. These disorders not only involve neuropsychiatric symptoms but also significantly impact physical health. In individuals with these conditions, sedentary lifestyle habits, metabolic side effects of antipsychotic and mood-stabilizing medications, and increased comorbidity risks are associated with notable reductions in exercise capacity.

Moreover, physical inactivity and heightened inflammatory processes may adversely affect respiratory muscle strength and pulmonary function. Studies have shown that patients with schizophrenia exhibit significantly lower maximal oxygen consumption (VO₂max) and anaerobic threshold levels compared to healthy individuals. In bipolar disorder, depressive episodes are marked by reduced exercise capacity, while manic episodes often involve irregular and risky physical activities.

Additionally, both disorders are associated with significantly lower pulmonary function parameters (FVC, FEV₁) compared to the healthy population. Respiratory muscle strength, a relatively underexplored area, is gaining importance. In schizophrenia cases dominated by negative symptoms, reduced inspiratory muscle strength combined with insufficient physical activity can severely limit patients' quality of life and independence. Similarly, in bipolar disorder, impairments in pulmonary capacity and respiratory muscle strength negatively affect quality of life.

Quality of life in these individuals is closely linked not only to mental health but also to physical capacity and pulmonary function. Enhancing respiratory muscle strength and aerobic capacity may positively influence overall quality of life, social participation, and functional status. However, the existing literature remains limited and fragmented. There is a noticeable lack of studies that simultaneously evaluate exercise capacity, pulmonary function, and respiratory muscle strength in individuals with psychiatric disorders.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being volunteer for participation
  • Being 18 to 65 age

排除标准

  • Having any respiratory, cardiac, neurologic or orthopedic disease which may affect respiratory functions or exercise capacity
  • Having any neuropsychiatric disease except schizophrenia or bipolar disorder

结局指标

主要结局

Maximum Inspiratory Pressure (MIP) measurement

时间窗: 1st day

MIP will be measured using a mouth pressure device on Day 1 of the intervention. The maximum inspiratory pressure (MIP) will be recorded in cmH₂O. Three assessments will be performed, and the highest value will be reported.

Maximum Expiratory Pressure (MEP) measured in cmH₂O

时间窗: 1st day

MEP will be measured using a mouth pressure device on Day 1 of the intervention. The maximum expiratory pressure (MEP) will be recorded in cmH₂O. Three assessments will be performed, and the highest value will be reported.

Forced Expiratory Volume in 1 Second (FEV1) measured in liters

时间窗: 1st day

FEV1 will be measured using spirometry on Day 1 of the intervention. The maximum expiratory volume in 1 second (FEV1) will be recorded in liters. Three assessments will be performed, and the highest value will be reported.

Peak Expiratory Flow (PEF) measurement

时间窗: 1st day

PEF will be measured using spirometry on Day 1 of the intervention. The peak expiratory flow (PEF) will be recorded in liters per minute. Three assessments will be performed, and the highest value will be reported.

Forced Vital Capacity (FVC) measured in liters

时间窗: 1st day

FVC will be measured using spirometry on Day 1 of the intervention. The forced vital capacity (FVC) will be recorded in liters. Three assessments will be performed, and the highest value will be reported.

FEV1/FVC ratio measured as a percentage

时间窗: 1st day

FEV1/FVC ratio will be calculated using spirometry on Day 1 of the intervention. The ratio of FEV1 to FVC will be expressed as a percentage. Three assessments will be performed, and the highest value will be reported.

次要结局

  • 6-minute walk distance (6MWD) measured in meters(1st day)
  • WHOQOL-BREF total score measurement(1st day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Furkan Özdemir

Lecturer

Çankırı Karatekin University

研究点 (1)

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