NCT06181123

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 26, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

November 29, 2023

Last Update Submit

February 21, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (9)

  • Vertical jump test (Functionality 1)

    in a time through the study completion, an average of 5 minutes

  • Forced vital capacity (FVC) (Pulmonary function)

    Baseline

  • forced expiratory volume in the first second (FEV1) (Pulmonary function)

    Baseline

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

    Baseline

  • peak expiratory flow rate (PEF)

    Baseline

  • +4 more secondary outcomes

Study Arms (2)

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

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

Interventions

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).

Also known as: assesments
Patient grouphealthy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* being over 18 years of age * being diagnosed with mood disorders

You may qualify if:

  • 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

You may not qualify if:

  • Individuals with significant cardiovascular, neuromuscular and endocrine disorders,
  • pregnant women,
  • people under 18 years old
  • disabled individuals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatay Mustafa Kemal University

Hatay, Merkez, 31010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Mood DisordersSedentary BehaviorRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Mental DisordersBehaviorRespiration DisordersRespiratory Tract Diseases

Study Officials

  • İrem Görgün, student

    Mustafa Kemal University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 26, 2023

Study Start

May 1, 2023

Primary Completion

July 30, 2023

Study Completion

December 30, 2023

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations