- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03840941
The Effect of Frailty on Balance, Activities of Daily, and Exercise Capacity in COPD
The Effect Of Frailty Level On Balance, Cognition And Activities Of Daily Living In COPD
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sihhiye
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Ankara, Sihhiye, Turkey, 06100
- Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Frail patients with COPD
No intervention
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Non-frail patients with COPD
No intervention
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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.
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1st Day
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Balance Assessment Using Functional Reach Test
Time Frame: 1st Day
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The Functional Reach Test measures how far patient can reach forward from a normal relaxed stance.
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1st Day
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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
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Perform activities of daily living (ADL) will be evaluated using the Glittre ADL-test
Time Frame: 1st Day
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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).
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1st Day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise Capacity Using 6-Minute Walk Test
Time Frame: 1st Day
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The standard protocol of the test is applied in a 30-meter continuous corridor.
Standard instructions are given during testing.
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1st Day
|
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Disease-Related Quality of Life Assessment
Time Frame: 1st Day
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COPD evaluation test (CAT) was developed to help assess health status.
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1st Day
|
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Respiratory Muscle Strength Assessment
Time Frame: 1st Day
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Respiratory muscle strength will be evaluated by non-invasive methods by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
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1st Day
|
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Shortness of Breath Assessment
Time Frame: 1st Day
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Modified Medical Research Council (mMRC) dyspnea scale will be used to determine the shortness of breath severity.
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1st Day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Deniz Inal-Ince, PhD, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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