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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03840941
Recruitment Status : Unknown
Verified October 2019 by Deniz Inal-Ince, Hacettepe University.
Recruitment status was:  Recruiting
First Posted : February 15, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Deniz Inal-Ince, Hacettepe University

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

Condition or disease
COPD Frailty

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 Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Effect Of Frailty Level On Balance, Cognition And Activities Of Daily Living In COPD
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : October 15, 2019
Estimated Study Completion Date : October 15, 2019
Groups and Cohorts
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Group/Cohort
Frail patients with COPD
No intervention
Non-frail patients with COPD
No intervention


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03840941


Contacts
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Contact: Deniz Inal-Ince, PhD +903123051577 ext 148 dinalince@yahoo.com
Contact: Sezen Ulusoy, PT +903123051577 ext 148 sezenulusoy@hacettepe.edu.tr

Locations
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Turkey
Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation Recruiting
Ankara, Sihhiye, Turkey, 06100
Contact: Sezen Ulusoy, Researcher    +903123051576    s.sezenulusoy@gmail.com   
Contact: Deniz Inal-Ince, PhD, PT    +903123051577 ext 148    dinalince@yahoo.com   
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Deniz Inal-Ince, PhD Hacettepe University
More Information
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Responsible Party: Deniz Inal-Ince, Prof. Dr., Hacettepe University
ClinicalTrials.gov Identifier: NCT03840941    
Other Study ID Numbers: GO 18/83-22
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deniz Inal-Ince, Hacettepe University:
COPD
Frailty
Balance
Cognition
Activities of Daily Living
Additional relevant MeSH terms:
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Frailty
Pathologic Processes