NCT06099002

Brief Summary

A descriptive study evaluating balance, gait speed, Quadriceps Femoris muscle strength and quality of life in individuals with Chronic obstructive pulmonary disease (COPD) who fell and did not fall.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 30, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

September 12, 2023

Last Update Submit

October 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fall Effectiveness Scale

    It contains 10 questions. Each question is given a score between 1-10. 1 point means very confident, 10 points means not at all confident. A patient with a score above 70 is said to have a fear of falling.

    15.04.2023-30.09.2024

Secondary Outcomes (3)

  • To measure balance Berg Balance Scala

    15.04.2023-30.09.2024

  • Quadriceps Femoris muscle strength falling and non-falling individuals with COPD

    15.04.2023-30.09.2024

  • Two Minute Walk Test

    15.04.2023-30.09.2024

Study Arms (2)

Individuals with COPD over the age of 65 with a history of falls

Individuals with COPD who were over the age of 65 and had a history of falling were included in this group.

Other: Changed Medical research Council,Mini Mental Test, Quadriceps Femoris muscle strength measurement,2 min walking test, fall effectiveness scale,Fall risk self-assessment scale

Individuals with COPD who are over the age of 65 and have no history of falling

Individuals with COPD who were over the age of 65 and did not have a history of falling were included in this group.

Other: Changed Medical research Council,Mini Mental Test, Quadriceps Femoris muscle strength measurement,2 min walking test, fall effectiveness scale,Fall risk self-assessment scale

Interventions

All individuals were given a respiratory function test to evaluate respiratory functions before and after training Modified Medical research Council to evaluate dyspnea, Mini Mental Test to evaluate cognitive status , Berg Balance Test to evaluate balance, 2-minute walk test to evaluate walking speed. A hand dynamometer will be used to measure QuadricepsFemoris muscle strength, Fall efficiency scale Fall risk self-assessment scale will be used to evaluate falls.

Individuals with COPD over the age of 65 with a history of fallsIndividuals with COPD who are over the age of 65 and have no history of falling

Eligibility Criteria

Age65 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with COPD over the age of 65

You may qualify if:

  • Being diagnosed with COPD according to criteria
  • Not having had an attack in the last 2 months
  • Volunteering to participate in the study
  • Being 65 years or older
  • Not having any mental or communication problems that prevent filling out the surveys to be used in the research.

You may not qualify if:

  • Having unstable COPD
  • Unstable angina, previous Myocardial Infarction, uncontrolled hypertension, cancer, neurological or musculoskeletal diseases with functional limitations
  • Being currently addicted to alcohol or drugs
  • Being in the process of COPD exacerbation
  • Having severe vision and hearing problems
  • Having severe cognitive impairment
  • Having had major surgery in the last few months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirikkale High Specialization Hospital

Kırıkkale, Merkez, 71100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

September 12, 2023

First Posted

October 25, 2023

Study Start

December 30, 2023

Primary Completion

April 30, 2024

Study Completion

May 30, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations