The Effect of Frailty on Balance, Activities of Daily, and Exercise Capacity in COPD

Completed

• Conditions: COPD; Frailty

• Registration Number: NCT03840941
• Lead Sponsor: Hacettepe University

Brief Summary

The investigators aim to demonstrate whether balance, cognition and activities of daily living have changed in COPD patients with and without frailty.

Detailed Description

COPD is a common, preventable and treatable disease characterized by progressive respiratory symptoms and airflow limitation. Frailty defines a clinical syndrome characterized by multiple system effects, leading to decreased functional reserve and increased sensitivity to dependence or mortality following minor stress events. Inflammation, lack of physical activity, reduced exercise efficiency and maximum oxygen uptake may contribute to the development of frailty in patients with COPD. Balance, cognition and activities of daily living are associated with COPD.

This study will evaluate the effect of frailty on balance, cognition and activities of daily living in patients with COPD.

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2019-02-12
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Primary Completion: 2019-10-15
• Study Completion: 2019-10-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• COPD patients who have been clinically stable for the last four weeks and who have not undergone drug change for the last four weeks
• Being 55 years of age or older
• Accepted to participate in the study (Able and wililing to complete the informed consent process)
• Co-operate
• Patients with COPD who are ambulant without support or an assistive device

Exclusion Criteria

• Neurological, cardiac or orthopedic diseases
• Other chronic diseases that may affect balance and walking

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perform activities of daily living (ADL) will be evaluated using the Glittre ADL-test	1st Day	Glittre ADL-test was designed specifically to assess the functional limitation in patients with COPD. Glittre ADL-test time will be considered the main outcome variable, and will be recorded in minutes (metric).
Presence of The Frailty Will Be evaluated Using The Frailty Criteria by Fried	1st Day	Frailty will be identified by the presence of three or more of the following criteria unintentional weight loss (10 Ibs in past year), weakness (grip strength), self-reported exhaustion, slow walking speed and low physical activity. Patients with three or more of the criteria present were classified as frail.
Balance Assessment Using Functional Reach Test	1st Day	The Functional Reach Test measures how far patient can reach forward from a normal relaxed stance.
Cognition Using MoCA-Test	1st Day	Cognitive function will be evaluated with the secreening tool the Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point screening tool.

Secondary Outcome Measures

Name	Time	Method
Disease-Related Quality of Life Assessment	1st Day	COPD evaluation test (CAT) was developed to help assess health status.
Respiratory Muscle Strength Assessment	1st Day	Respiratory muscle strength will be evaluated by non-invasive methods by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
Shortness of Breath Assessment	1st Day	Modified Medical Research Council (mMRC) dyspnea scale will be used to determine the shortness of breath severity.
Exercise Capacity Using 6-Minute Walk Test	1st Day	The standard protocol of the test is applied in a 30-meter continuous corridor. Standard instructions are given during testing.

Trial Locations

Locations (1)

Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation; 🇹🇷 Ankara, Sihhiye, Turkey