- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06181123
Cardiopulmonary Assesments in Mood Disorders
February 21, 2024 updated by: Irem Hüzmeli, Mustafa Kemal University
Comparison of Functionality, Physical Activity, Cardiac and Respiratory Parameters Between Patients With Mood Disorders and Healthy Controls
The importance of cardiorespiratory impact in mental diseases is generally emphasized in studies, but it is noteworthy that cardiorespiratory affects in mood disorders have not been sufficiently investigated.
This study aims to compare individuals with mood disorders and healthy people in terms of exercise capacity, functionality, respiratory muscle strength, respiratory functions, dyspnea and physical activity level.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The cross-sectional study was carried out with 30 patients with diagnosis of mood disorder who applied to the Hatay Mustafa Kemal University Research and Practice Hospital, Mental Health and Diseases clinic, and 35 healthy individuals whose age, gender were matched.
Clinical characteristics, exercise capacity (6-minute walking test, 6MWT; 3-minute Step test, 3MST), functionality (vertical jump test, functional reach test), respiratory parameters (Respiratory muscle strength, pulmonary function test), dyspnea (Modified Medical Research Council, MMRC scale), physical activity level (short form international physical activity questionnaire, IPAQ) was evaluated.
Study Type
Observational
Enrollment (Actual)
65
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Merkez
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Hatay, Merkez, Turkey, 31010
- Hatay Mustafa Kemal University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
- being over 18 years of age
- being diagnosed with mood disorders
Description
Inclusion Criteria:
- Healthy volunteers who had undergone a general physical examination in the past 6 month
- reported being free of significant cardiovascular, respiratory, neuromuscular, and endocrine disorders that preclude safe participation
Exclusion Criteria:
- Individuals with significant cardiovascular, neuromuscular and endocrine disorders,
- pregnant women,
- people under 18 years old
- disabled individuals.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
healthy group
Demographic data, clinical characteristics, exercise capacity (6 MWT, 3 min.
Step test), functionality (vertical jump test, functional reach test), respiratory parameters (Respiratory muscle strength, pulmonary function test, MMRC scale), physical activity level (IPAQ, short form).
|
The following were evaluated to make comparisons between the two groups: Demographic data, clinical characteristics, exercise capacity (6 MWT, 3 min.
Step test), functionality (vertical jump test, functional reach test), respiratory parameters (Respiratory muscle strength, pulmonary function test, MMRC scale), physical activity level (IPAQ, short form).
Other Names:
|
|
Patient group
Demographic data, clinical characteristics, exercise capacity (6 MWT, 3 min.
Step test), functionality (vertical jump test, functional reach test), respiratory parameters (Respiratory muscle strength, pulmonary function test, MMRC scale), physical activity level (IPAQ, short form).
|
The following were evaluated to make comparisons between the two groups: Demographic data, clinical characteristics, exercise capacity (6 MWT, 3 min.
Step test), functionality (vertical jump test, functional reach test), respiratory parameters (Respiratory muscle strength, pulmonary function test, MMRC scale), physical activity level (IPAQ, short form).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Six minute walking test (Evaluation of exercise capacity)
Time Frame: Baseline
|
Six minute walking test, The patients were allowed to rest for at least 30 minutes pre-starting the test, which was performed according to ATS criteria.
The participants were asked to walk as fast as they can without running in a 30-meter straight corridor for 6 minutes at their own walking pace
|
Baseline
|
|
3 minute step test (Assessment of exercise capacity)
Time Frame: Baseline
|
3 minute step test, In this test, the person ascends and descends the 30.5 cm step with the rhythm of the metronome set at 96 beats/min for 3 minutes.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vertical jump test (Functionality 1)
Time Frame: in a time through the study completion, an average of 5 minutes
|
Vertical jump test, The vertical jump test is used to evaluate performance characteristics.
The person to be tested lies on a flat platform as far as he can with one arm, placing equal weight on both extremities, and is marked.
Then, the person jumps and the last point he can reach by jumping is marked.
Applying these procedures, the difference between the two marked points was recorded .
|
in a time through the study completion, an average of 5 minutes
|
|
Forced vital capacity (FVC) (Pulmonary function)
Time Frame: Baseline
|
Pulmonary function test was performed with a portable spirometer (SPIROBANK II® USA).
Forced vital capacity (FVC).
The test was performed in the sitting position.
The best of the 3 maneuvers that were technically acceptable and had 95% agreement with each other was selected for statistical analysis.
|
Baseline
|
|
forced expiratory volume in the first second (FEV1) (Pulmonary function)
Time Frame: Baseline
|
Pulmonary function test was performed with a portable spirometer (SPIROBANK II® USA).
forced expiratory volume in the first second (FEV1)
|
Baseline
|
|
ratio of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC)
Time Frame: Baseline
|
Pulmonary function test
|
Baseline
|
|
peak expiratory flow rate (PEF)
Time Frame: Baseline
|
Pulmonary function test
|
Baseline
|
|
forced mid-expiratory flow rate (FEF25-75%)
Time Frame: Baseline
|
Pulmonary function test
|
Baseline
|
|
Respiratory muscle strenght
Time Frame: Baseline
|
Respiratory muscle strength was evaluated using a portable, electronic oral pressure measurement device (MicroRPM, Micro Medical England) according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Respiratory muscle strength was evaluated with an oral pressure device that gives MIP MEP results.
If the difference was greater than 5% or 5 cmH2O between the two best measured values, the measurement was repeated, and the best values for the analyses were kept.
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Baseline
|
|
Physical activity
Time Frame: Baseline
|
The physical activity level was evaluated using the short form of the International Physical Activity Questionnaire (IPAQ) (21).
IPAQ consists of seven questions in total.
|
Baseline
|
|
The Functional Reaching Test (Functionality 2)
Time Frame: Baseline
|
In the Functional Reaching Test, another functionality test, the individual approaches the wall in a sideways position with shoulder facing the wall.
Then, the individual opens the feet at shoulder level and clasps the hand, bringing it to a 90-degree flexion position.
The part where the 3rd metacarpal bone of the hand meets the wall is marked.
The participant is asked to lie forward as much as possible without breaking the contact of the heels with the ground and without taking a step.
Then, the distance between this starting and ending point is recorded.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: İrem Görgün, student, Mustafa Kemal University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Actual)
July 30, 2023
Study Completion (Actual)
December 30, 2023
Study Registration Dates
First Submitted
November 29, 2023
First Submitted That Met QC Criteria
December 22, 2023
First Posted (Actual)
December 26, 2023
Study Record Updates
Last Update Posted (Actual)
February 22, 2024
Last Update Submitted That Met QC Criteria
February 21, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mustafa Kemal University
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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