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

NCT03840941 | Completed

• 1 other identifier: GO 18/83-22
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COPD; Frailty

Keywords

COPD; Frailty; Balance; Cognition; Activities of Daily Living

Outcome Measures

Primary Outcomes (4)

• 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

• Balance Assessment Using Functional Reach Test

  The Functional Reach Test measures how far patient can reach forward from a normal relaxed stance.

  1st Day

• 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

• 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 Outcomes (4)

• Exercise Capacity Using 6-Minute Walk Test

  1st Day

• Disease-Related Quality of Life Assessment

  1st Day

• Respiratory Muscle Strength Assessment

  1st Day

• Shortness of Breath Assessment

  1st Day

Study Arms (2)

Frail patients with COPD

No intervention

Non-frail patients with COPD

No intervention

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals who are diagnosed with COPD at Hacettepe University and who are referred to the Cardiopulmonary Rehabilitation Unit for physiotherapy also who are willing to participate in the study will be included in the study.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Ankara, Sihhiye, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Frailty

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Deniz Inal-Ince, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 15, 2019
• Study Start: March 1, 2018
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

TU (1)