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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
    • Merkez
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Other: Cardiorespiratory 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).
Other Names:
  • 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).
Other: Cardiorespiratory 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).
Other Names:
  • assesments

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mustafa Kemal University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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