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

November 30, 2023 updated by: Deniz Inal-Ince, Hacettepe University

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sihhiye
      • Ankara, Sihhiye, Turkey, 06100
        • Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Frail patients with COPD
No intervention
Non-frail patients with COPD
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1st Day
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.
1st Day
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.
1st Day
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).
1st Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1st Day
Disease-Related Quality of Life Assessment
Time Frame: 1st Day
COPD evaluation test (CAT) was developed to help assess health status.
1st Day
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).
1st Day
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.
1st Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Deniz Inal-Ince, PhD, Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

October 15, 2019

Study Completion (Actual)

October 15, 2019

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

February 12, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO 18/83-22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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