NCT05005533

Brief Summary

As a result of the study, inspiratory muscle strength, posture and physical performance evaluations of individuals with Chronic Obstructive Pulmonary Disease will be made, suggestions will be made to help individual postural smoothness and improve physical performance.

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 15, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

August 7, 2021

Last Update Submit

March 27, 2023

Conditions

Keywords

Chronic Obstructive Pulmonary DiseaseRespiratory Muscle StrengthPostureBalanceFunctional Capacity

Outcome Measures

Primary Outcomes (1)

  • Maximal Inspiratory Pressure

    Respiratory muscle strength will be assessed by maximal inspiratory pressure. Values in the normal range indicate normal respiratory muscle strength, low values indicate decreased respiratory muscle strength.

    5 minutes

Secondary Outcomes (9)

  • Posture Assessment

    5 minutes

  • Biodex Balance System

    5 minutes

  • Time Up and Go Test

    2 minutes

  • Short Physical Performance Test

    5 minutes

  • Chronic Obstructive Pulmonary Disease Assessment Test

    2 minutes

  • +4 more secondary outcomes

Study Arms (2)

Mild and Moderate Severe Group

Individuals with Chronic Obstructive Pulmonary Disease with a Forced Expiratory Volume greater than 50% of the expected value

Other: Observational

Severe and Very Severe Group

Individuals with Chronic Obstructive Pulmonary Disease whose Forced Expiratory Volume is less than 50% of the expected value

Other: Observational

Interventions

Chronic Obstructive Pulmonary Disease Severity of Individuals by Chronic Obstructive Pulmonary Disease Assessment Test, shortness of breath Modified Medical Research Council scale, cough related quality of life Leicester Cough Questionnaire, respiratory muscle strength with Maximum Inspiratory and Expiratory Pressure, Posture with Spinal Mouse device, pain with Visual Analog Scale, severity of fatigue Fatigue Physical performance of the lower extremities will be evaluated with the Short Physical Performance Test, functional mobility will be evaluated with the Time Up and Go Test, and balance will be evaluated with the Biodex Balance System

Mild and Moderate Severe GroupSevere and Very Severe Group

Eligibility Criteria

Age40 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic obstructive pulmonary disease is a common, preventable and treatable disease characterized by persistent respiratory symptoms and airway limitation due to airway and/or alveolar abnormality resulting from exposure to harmful gases or particles and many factors that cause abnormal lung development.

You may qualify if:

  • Being diagnosed with Chronic Obstructive Pulmonary Disease according to the Global Initiative for Chronic Obstructive Lung Disease criteria
  • Not having vision, hearing and speech problems
  • Volunteering to participate in the research

You may not qualify if:

  • Have had major surgery in the past few months
  • History of recurrent significant clinical infection
  • Having cognitive problems
  • Unstable angina, previous myocardial infarction (MI),
  • Severe congestive heart failure resistant to medical treatment,
  • Having uncontrolled hypertension,
  • Get cancer
  • Having neurological or musculoskeletal diseases with functional limitations
  • Having suffered an injury, such as a sprain, sprain or fracture of the lower extremity in the last 6 months, unable to perform independent ambulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant İzzet Baysal University Department of Physiotherapy and Rehabilitation

Bolu, 14000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Central Study Contacts

Eylem TÜTÜN YÜMİN, Assoc. Prof.

CONTACT

Ceyhun TOPCUOĞLU, Res. Assist.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2021

First Posted

August 13, 2021

Study Start

March 15, 2021

Primary Completion

February 15, 2023

Study Completion

May 15, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations