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Completed

NCT Number: NCT06181123

Cardiopulmonary Assesments in Mood Disorders

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.

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Key information

Conditions

Mood Disorders Behavior Mental Disorders Physical Inactivity Respiration Disorders Respiratory Function Impaired Respiratory Insufficiency Respiratory Tract Diseases Sedentary Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hatay Mustafa Kemal University

Hatay, Merkez, 31010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiorespiratory Assesments

Other

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

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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 .

  2. 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.

  3. 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)

  4. ratio of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC)

    Time frame: Baseline

    Pulmonary function test

  5. peak expiratory flow rate (PEF)

    Time frame: Baseline

    Pulmonary function test

  6. forced mid-expiratory flow rate (FEF25-75%)

    Time frame: Baseline

    Pulmonary function test

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Mustafa Kemal University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Comparison of Functionality, Physical Activity, Cardiac and Respiratory Parameters Between Patients With Mood Disorders and Healthy Controls

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 26, 2023
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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