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

NCT07306468 | Recruiting

• 1 other identifier: 2025-06-26
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophenia Disorder; Bipolar Disorder (BD)

Keywords

schizophrenia; bipolar disorder; respiratory functions; quality of life; exercise capacity

Outcome Measures

Primary Outcomes (6)

• Maximum Inspiratory Pressure (MIP) measurement

  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.

  1st day

• Maximum Expiratory Pressure (MEP) measured in cmH₂O

  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.

  1st day

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

  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.

  1st day

• Forced Vital Capacity (FVC) measured in liters

  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.

  1st day

• FEV1/FVC ratio measured as a percentage

  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.

  1st day

• Peak Expiratory Flow (PEF) measurement

  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.

  1st day

Secondary Outcomes (2)

• 6-minute walk distance (6MWD) measured in meters

  1st day

• WHOQOL-BREF total score measurement

  1st day

Study Arms (3)

Schizophrenia

Patients diagnosed with schizophrenia

Other: Pulmonary Function Test; Other: Respiratory Muscle Strength Evaluation; Other: Quality of Life Assessment; Other: Exercise Capacity Assessment

Bipolar Disorder

Patients diagnosed with bipolar disorder

Other: Pulmonary Function Test; Other: Respiratory Muscle Strength Evaluation; Other: Quality of Life Assessment; Other: Exercise Capacity Assessment

Healthy Control

Participants who have any diagnosed diseases/disorders

Other: Pulmonary Function Test; Other: Respiratory Muscle Strength Evaluation; Other: Quality of Life Assessment; Other: Exercise Capacity Assessment

Interventions

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

Bipolar Disorder; Healthy Control; Schizophrenia

Pulmonary Function Test OTHER

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

Bipolar Disorder; Healthy Control; Schizophrenia

Quality of Life Assessment OTHER

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

Bipolar Disorder; Healthy Control; Schizophrenia

Exercise Capacity Assessment OTHER

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

Bipolar Disorder; Healthy Control; Schizophrenia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of individuals diagnosed with schizophrenia or bipolar disorder who are currently receiving standard medical treatment at the Community Mental Health Center of Çankırı State Hospital. Participants will be aged between 18 and 65 years, literate, and willing to participate in the study. No sampling method will be applied; all eligible individuals who meet the inclusion criteria and provide informed consent will be enrolled. Based on a prior sample size analysis conducted using data collected under approved ethical clearance, the study aims to include a total of 150 participants-50 individuals in each diagnostic group (schizophrenia, bipolar disorder and healthy controls). This sample size is expected to provide sufficient statistical power to detect differences between groups in terms of exercise capacity, pulmonary function, respiratory muscle strength, and quality of life.

You may qualify if:

• Being volunteer for participation
• Being 18 to 65 age

You may not qualify if:

• 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

Sponsors & Collaborators

• Çankırı Karatekin University: lead

Study Sites (1)

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

Çankırı, Çankırı, 18100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder; Schizophrenia

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Furkan Özdemir, PT, Ph.D.

CONTACT

+905383264855; furkanozdemir@karatekin.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 29, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)