NCT06298994

Brief Summary

The aim of this study is to investigate body awareness and functional movement in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to healthy controls.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

March 8, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2026

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

February 27, 2024

Last Update Submit

March 5, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Evaluation of functional movement

    Functional movement analysis will be performed via The Functional Movement Screen.

    1 day

  • Evaluation of Body Awareness

    Body awareness will be assessed via Body Awareness Rating Questionnaire. It consists of 24 questions and each item is scored on a 7-point Likert-type scale. The total score ranges from 24 to168. A Higher scores indicate higher body awareness.

    1 day

Secondary Outcomes (10)

  • Functional exercise capacity

    1 day

  • Respiratory muscle strength

    1

  • Respiratory muscle endurance

    1 day

  • Pain Severity

    1 day

  • Pain threshold

    1 day

  • +5 more secondary outcomes

Study Arms (2)

study group

Patients with Chronic Obstructive Pulmonary Disease

control group

Aged-matched healthy controls

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with COPD and aged matched healthy controls will be included in this study.

You may qualify if:

  • Being under 55 years old
  • To be literate,
  • Having volunteered to participate in the research,
  • Stage 1-2-3-4 according to the Classification of Airflow Limitation in COPD (GOLD) system,
  • Being clinically stable for the last 2 weeks.

You may not qualify if:

  • Having history of lung cancer, sarcoidosis, tuberculosis and/or lung surgery,
  • Communication problems,
  • Having a severe psychiatric disorder.
  • Not having any cardiopulmonary system disease or chronic systemic disease,
  • To be literate,
  • Being under 55 years old
  • Be willing to participate in the study.
  • Not having balance problems, musculoskeletal, neurological and psychiatric disorders that could prevent performing the test procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aynur Demirel

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyskinesiasPain

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator; PT, PhD, Assoc. Prof.

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 7, 2024

Study Start

March 8, 2024

Primary Completion

March 8, 2025

Study Completion

March 8, 2026

Last Updated

March 7, 2024

Record last verified: 2024-03

Locations