Mood DisordersNCT06181123
Cardiopulmonary Assesments in Mood Disorders
An observational study of Mood Disorders and Physical Inactivity, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mood Disorders, Physical Inactivity, Respiratory Function Impaired
- What is being tested?
- Cardiorespiratory Assesments
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * being over 18 years of age * being diagnosed with mood disorders
Who may be able to join
- 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
Who cannot join
- Individuals with significant cardiovascular, neuromuscular and endocrine disorders,
- pregnant women,
- people under 18 years old
- disabled individuals.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hatay Mustafa Kemal University
Hatay, Merkez, 31010
About this study
Official title: 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.
Read the 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.
- Being tested
- Cardiorespiratory Assesments
- Medical subject headings
- Mood Disorders, Sedentary Behavior, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiorespiratory AssesmentsOther
Also called assesments
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Cardiorespiratory Assesments | |
| 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). Receives: Other: Cardiorespiratory Assesments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minute walking test (Evaluation of exercise capacity)
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
Measured: Baseline
3 minute step test (Assessment of exercise capacity)
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.
Measured: Baseline
Secondary outcomes (9)
Vertical jump test (Functionality 1)
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 .
Measured: in a time through the study completion, an average of 5 minutes
Forced vital capacity (FVC) (Pulmonary function)
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.
Measured: Baseline
forced expiratory volume in the first second (FEV1) (Pulmonary function)
Pulmonary function test was performed with a portable spirometer (SPIROBANK II® USA). forced expiratory volume in the first second (FEV1)
Measured: Baseline
ratio of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC)
Pulmonary function test
Measured: Baseline
peak expiratory flow rate (PEF)
Pulmonary function test
Measured: Baseline
forced mid-expiratory flow rate (FEF25-75%)
Pulmonary function test
Measured: Baseline
Respiratory muscle strenght
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.
Measured: Baseline
Physical activity
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.
Measured: Baseline
The Functional Reaching Test (Functionality 2)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 May 2023
- Primary completion30 Jul 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Irem Hüzmeli, Mustafa Kemal University
- Investigators
- İrem Görgün, student, Study director, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181123
- Sponsor's protocol ID
- Mustafa Kemal University
- Status last verified
- Feb 2024
- First submitted
- 29 Nov 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Functionality, Physical Activity, Cardiac and Respiratory Parameters Between Patients With Mood Disorders and Healthy Controls
- ClinicalTrials.gov ID
- NCT06181123
- Acronym / sponsor ID
- Mustafa Kemal University
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy group | – | Other: Cardiorespiratory AssesmentsDemographic 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). |
| Patient group | – | Other: Cardiorespiratory AssesmentsDemographic 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * being over 18 years of age * being diagnosed with mood disorders
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Individuals with significant cardiovascular, neuromuscular and endocrine disorders,
- pregnant women,
- people under 18 years old
- disabled individuals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiorespiratory AssesmentsAlso: assesmentsThe 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 | Patient group, healthy group |
Primary outcome
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
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.
9 secondary outcomes
Vertical jump test (Functionality 1)
Time frame: in a time through the study completion, an average of 5 minutes
Forced vital capacity (FVC) (Pulmonary function)
Time frame: Baseline
forced expiratory volume in the first second (FEV1) (Pulmonary function)
Time frame: Baseline
ratio of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC)
Time frame: Baseline
peak expiratory flow rate (PEF)
Time frame: Baseline
forced mid-expiratory flow rate (FEF25-75%)
Time frame: Baseline
Respiratory muscle strenght
Time frame: Baseline
Physical activity
Time frame: Baseline
The Functional Reaching Test (Functionality 2)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İrem Görgün, student study director
Mustafa Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mood Disorders and Physical Inactivity, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six minute walking test (Evaluation of exercise capacity) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.