NCT04048408

Brief Summary

In the literature, there are a limited number of studies evaluating postural awareness, cognitive status, respiratory muscle strength and endurance, functional capacity, and pain in people with obstructive pulmonary disease, and comparing these parameters with each other and with healthy subjects, and most of the studies are on chronic obstructive pulmonary disease patients. There we will evaluate these parameters in different obstructive lung diseases and compare the findings of healthy individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

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

January 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

August 6, 2019

Last Update Submit

July 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain Perception

    Pain Perception Threshold and Tolerance With Algometer

    01.01.2019-31.08.2019

Secondary Outcomes (4)

  • Cognitive Function Assessment

    01.01.2019-31.08.2019

  • Functional capacity assesment

    01.01.2019-31.08.2019

  • Postural awareness assesment

    01.01.2019-31.08.2019

  • Respiratory muscle strength and endurance measurement

    01.01.2019-31.08.2019

Study Arms (2)

Obstructive lung diseases group

Healthy group

Eligibility Criteria

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

Obstructive lung diseases in 18-65 years old

You may qualify if:

  • To be diagnosed with obstructive pulmonary disease,
  • Have not experienced acute exacerbation in the last 3 months,
  • Being between the ages of 18-65,
  • Not having chronic pain problems,
  • Volunteer for research,
  • To be able to walk and cooperate.

You may not qualify if:

  • To be able to diagnose neurological disorder,
  • To have an advanced orthopedic disease that may affect functional capacity measurement.
  • To have any cardiopulmonary disease,
  • To have an advanced orthopedic disease that may affect functional capacity measurement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Ankara, Please Choose A State, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic PainLung Diseases, ObstructiveCognitive Dysfunction

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Ebru Calik Kutukcu, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Melda Saglam, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Deniz Inal Ince, Professor

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Hulya Arikan, Professor

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Naciye Vardar Yagli, PhD

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 6, 2019

First Posted

August 7, 2019

Study Start

January 1, 2019

Primary Completion

June 24, 2020

Study Completion

June 24, 2020

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations