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

COPD Clinical Trial

Official title:

The Effect Of Frailty Level On Balance, Cognition And Activities Of Daily Living In COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03840941
• Other study ID #: GO 18/83-22
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: October 15, 2019

Study information

• Verified date: November 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Frailty

Locations

Country	Name	City	State
Turkey	Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation	Ankara	Sihhiye

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of The Frailty Will Be evaluated Using The Frailty Criteria by Fried	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.	1st Day
Primary	Balance Assessment Using Functional Reach Test	The Functional Reach Test measures how far patient can reach forward from a normal relaxed stance.	1st Day
Primary	Cognition Using MoCA-Test	Cognitive function will be evaluated with the secreening tool the Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point screening tool.	1st Day
Primary	Perform activities of daily living (ADL) will be evaluated using the Glittre ADL-test	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).	1st Day
Secondary	Exercise Capacity Using 6-Minute Walk Test	The standard protocol of the test is applied in a 30-meter continuous corridor. Standard instructions are given during testing.	1st Day
Secondary	Disease-Related Quality of Life Assessment	COPD evaluation test (CAT) was developed to help assess health status.	1st Day
Secondary	Respiratory Muscle Strength Assessment	Respiratory muscle strength will be evaluated by non-invasive methods by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).	1st Day
Secondary	Shortness of Breath Assessment	Modified Medical Research Council (mMRC) dyspnea scale will be used to determine the shortness of breath severity.	1st Day