Cardiopulmonary Assesments in Mood Disorders

Physical Inactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06181123
• Other study ID #: Mustafa Kemal University
• Status: Completed
• Start date: May 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2024
• Source: Mustafa Kemal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mood Disorders
• Physical Inactivity
• Respiratory Function Impaired
• Respiratory Insufficiency

Intervention

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).

Locations

Country	Name	City	State
Turkey	Hatay Mustafa Kemal University	Hatay	Merkez

Sponsors (2)

Lead Sponsor	Collaborator
Mustafa Kemal University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Primary	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.	Baseline
Secondary	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 .	in a time through the study completion, an average of 5 minutes
Secondary	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.	Baseline
Secondary	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)	Baseline
Secondary	ratio of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC)	Pulmonary function test	Baseline
Secondary	peak expiratory flow rate (PEF)	Pulmonary function test	Baseline
Secondary	forced mid-expiratory flow rate (FEF25-75%)	Pulmonary function test	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline