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


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

Full Title of Study: “The Effect Of Frailty Level On Balance, Cognition And Activities Of Daily Living In COPD”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 15, 2019

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.

Arms, Groups and Cohorts

  • Frail patients with COPD
    • No intervention
  • Non-frail patients with COPD
    • No intervention

Clinical Trial Outcome Measures

Primary Measures

  • Presence of The Frailty Will Be evaluated Using The Frailty Criteria by Fried
    • Time Frame: 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
    • Time Frame: 1st Day
    • The Functional Reach Test measures how far patient can reach forward from a normal relaxed stance.
  • Cognition Using MoCA-Test
    • Time Frame: 1st Day
    • Cognitive function will be evaluated with the secreening tool the Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point screening tool.
  • Perform activities of daily living (ADL) will be evaluated using the Glittre ADL-test
    • Time Frame: 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).

Secondary Measures

  • Exercise Capacity Using 6-Minute Walk Test
    • Time Frame: 1st Day
    • The standard protocol of the test is applied in a 30-meter continuous corridor. Standard instructions are given during testing.
  • Disease-Related Quality of Life Assessment
    • Time Frame: 1st Day
    • COPD evaluation test (CAT) was developed to help assess health status.
  • Respiratory Muscle Strength Assessment
    • Time Frame: 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
    • Time Frame: 1st Day
    • Modified Medical Research Council (mMRC) dyspnea scale will be used to determine the shortness of breath severity.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hacettepe University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Deniz Inal-Ince, Prof. Dr. – Hacettepe University
  • Overall Official(s)
    • Deniz Inal-Ince, PhD, Principal Investigator, Hacettepe University
  • Overall Contact(s)
    • Deniz Inal-Ince, PhD, +903123051577,

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