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Completed

NCT Number: NCT03840941

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.

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Key information

Conditions

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

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Ankara, Sihhiye, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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 outcomes

  1. 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.

  2. Disease-Related Quality of Life Assessment

    Time frame: 1st Day

    COPD evaluation test (CAT) was developed to help assess health status.

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2019
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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