Effects of Schizophrenia and Bipolar Disorder on Exercise Capacity, Pulmonary Function, and Quality of Life
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorÇankırı Karatekin University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Being volunteer for participation
Being 18 to 65 age
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Pulmonary Function Test
Other interventionParticipants' respiratory functions will assess with pulmonary function test according to ATS/ERS criteria
Respiratory Muscle Strength Evaluation
Other interventionParticipants' respiratory muscle strenght will assess with maximal inspiratory pressure and maximal expiratory pressure assessment according to ATS/ERS criteria
Quality of Life Assessment
Other interventionParticipants' quality of life will assess with WHOQOL-Bref questionnaire
Exercise Capacity Assessment
Other interventionParticipants' exercise capacity will assess with 6 Minute Walk Test according to ATS/ERS criteria
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Schizophrenia4 interventions
Group B: Bipolar Disorder4 interventions
Group C: Healthy Control4 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
1st day2
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.
Time frame
1st day3
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.
Time frame
1st day4
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.
Time frame
1st daySecondary outcomes
1
6-minute walk distance (6MWD) measured in meters
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.
Time frame
1st day2
WHOQOL-BREF total score measurement
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.
Time frame
1st daySponsors and contacts
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Source ClinicalTrials.gov