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NCT Number: NCT07306468

Effects of Schizophrenia and Bipolar Disorder on Exercise Capacity, Pulmonary Function, and Quality of Life

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Çankırı Karatekin University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Çankırı, 18100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Furkan Özdemir

CONTACT

[email protected]

+905383264855

About this study

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.

This study aims to contribute to the literature from a multidisciplinary perspective by jointly examining exercise capacity, pulmonary function, respiratory muscle strength, and quality of life in individuals diagnosed with schizophrenia and bipolar disorder. These individuals often exhibit unhealthy lifestyle habits and a tendency toward sedentary behavior, which are considered risk factors that may adversely affect physical fitness. Components of physical fitness include cardiorespiratory endurance and muscular endurance. In light of this information, a review of the literature reveals that data on pulmonary function, respiratory muscle strength, and endurance in individuals with schizophrenia and bipolar disorder are still limited. The findings obtained from this study may guide the development of more effective rehabilitation and physical health support programs for these populations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being volunteer for participation
  • Being 18 to 65 age

Exclusion criteria

  • 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

Treatment and study plan

pulmonary function test

Other

Participants' respiratory functions will assess with pulmonary function test according to ATS/ERS criteria

Respiratory Muscle Strength Evaluation

Other

Participants' respiratory muscle strenght will assess with maximal inspiratory pressure and maximal expiratory pressure assessment according to ATS/ERS criteria

Quality of Life Assessment

Other

Participants' quality of life will assess with WHOQOL-Bref questionnaire

Exercise Capacity Assessment

Other

Participants' exercise capacity will assess with 6 Minute Walk Test according to ATS/ERS criteria

Primary outcomes

  1. Maximum Inspiratory Pressure (MIP) measurement

    Time frame: 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.

  2. Maximum Expiratory Pressure (MEP) measured in cmH₂O

    Time frame: 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.

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

    Time frame: 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.

  4. Forced Vital Capacity (FVC) measured in liters

    Time frame: 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.

  5. FEV1/FVC ratio measured as a percentage

    Time frame: 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.

  6. Peak Expiratory Flow (PEF) measurement

    Time frame: 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.

Secondary outcomes

  1. 6-minute walk distance (6MWD) measured in meters

    Time frame: 1st day

    The 6-minute walk test will be conducted according to standardized procedures in a straight corridor. Participants will be instructed to walk as far as possible in 6 minutes with standardized encouragement. The total distance walked will be recorded in meters. If a test is interrupted, the distance completed will be recorded. Two assessments will be performed on the same day, separated by a 30-minute rest interval. The 6-minute walk distance (6MWD) will be measured in meters, and the best (highest) distance will be reported.

  2. WHOQOL-BREF total score measurement

    Time frame: 1st day

    Health-related quality of life will be assessed using the Turkish version of WHOQOL-BREF questionnaire. Participants will complete the 26-item survey at the 1st day. The total score will be calculated according to standardized scoring procedures and reported in points. Higher scores indicate better quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Furkan Özdemir, PT, Ph.D.

CONTACT

[email protected]

+905383264855

Sponsors and collaborators

Lead sponsor

Çankırı Karatekin University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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