Balance, Walking Speed, Quadriceps Femoris Muscle Strength and Quality of Life in Falling and Non-falling Individuals With COPD

Sponsor

Kırıkkale University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06099002

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Copd	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

Detailed Description

Falls in the elderly can have devastating consequences. The ability to maintain stability and balance is critical for functional independence, mobility, and avoidance of falls in activities of daily living. An impaired balance is associated with an increased risk of falls and causes a higher mortality rate among older adults. Balance impairment is independently associated with falls in patients with Chronic obstructive pulmonary disease. Well-known risk factors for falls in individuals with Chronic obstructive pulmonary disease include advanced age, increased comorbidities, dyspnea, physical inactivity, muscle weakness, fear and decreased balance confidence, as well as lower extremity muscle weakness. It has been reported that there are functional deficiencies, lack of performance and postural control. According to the results of a recent study, it was found that Chronic obstructive pulmonary disease is in the second place after osteoarthritis in chronic conditions where the prevalence of falls is highest. The prevalence of falls in individuals with Chronic obstructive pulmonary disease is estimated to range from 25% to 46%.

Study Design

Study Type:

Observational

Anticipated Enrollment :

74 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Balance, Walking Speed, Quadriceps Femoris Muscle Strength and Quality of Life in Falling and Non-falling Individuals With COPD

Anticipated Study Start Date :

Oct 30, 2023

Anticipated Primary Completion Date :

Aug 30, 2024

Anticipated Study Completion Date :

Aug 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
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 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 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 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.

Arm

Intervention/Treatment

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

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 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

Outcome Measures

Primary Outcome Measures

Fall Effectiveness Scale [15.04.2023-30.09.2024]
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.

Secondary Outcome Measures

To measure balance Berg Balance Scala [15.04.2023-30.09.2024]
To assess balance. The highest score is 56, scores between 0-20 indicate that the balance is disrupted, 21-41 indicates that the balance is acceptable, and 41-56 indicates that the balance is good.
Quadriceps Femoris muscle strength falling and non-falling individuals with COPD [15.04.2023-30.09.2024]
We measure the strength of the muscle by applying pressure from the knee with the help of a hand dynamometer.
Two Minute Walk Test [15.04.2023-30.09.2024]
The patient walks the longest distance he can in 2 minutes and the value is recorded in meters. The aim is to measure the patient's functional capacity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 84 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kirikkale High Specialization Hospital	Kırıkkale	Merkez	Turkey	71100

Sponsors and Collaborators

Kırıkkale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Meral SERTEL, associate professor, Kırıkkale University

ClinicalTrials.gov Identifier:

NCT06099002

Other Study ID Numbers:

KKU-FTR-YK-02

First Posted:

Oct 25, 2023

Last Update Posted:

Oct 25, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 25, 2023