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The Risk of Falling in Patients With Chronic Obstructive Pulmonary Disease

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: NCT04074499
Recruitment Status : Completed
First Posted : August 30, 2019
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Tansu Birinci, Istanbul University-Cerrahpasa

Brief Summary:
This cross-sectional study aims to investigate what daily activities increase the risk of falling in Chronic Obstructive Pulmonary Disease patients (COPD).

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Fall Balance; Distorted Activity, Motor Other: No intervention

Detailed Description:
To investigate the what daily activities increase the risk of falling in patients with COPD, twenty-eight voluntary patients with COPD, aged between 35-80 years will be divided into two groups: Group-1 have at least one fall (fallers) and Group-2 have no history of falls (non-fallers). Fall frequency will be investigated by asking patients to report any fall event in the last one month and the last 12-months. Assessments will be performed at baseline. Fear of falling will be assessed with Activities-Specific Balance Confidence (ABC) scale. Balance will be evaluated by Berg Balance Scale (BBS). The level of dyspnea during daily activities will be assessed with London Chest Activity of Daily Living (LCADL) scale. The global impacts of COPD symptoms on overall health status will be evaluated by The COPD Assessment Test (CAT). The Modified Medical Research Council Dyspnea (MMRC) scale and Six-Minute Walking Test (6MWT) will be used for evaluating the how dyspnea limits the patients' daily activities and functional capacity, respectively. Isometric muscle strength will be measured with a handheld dynamometer of quadriceps femoris. Pulmonary function data will be retrieved from the last 1-month clinical records of the COPD patients. Statistical analysis will be performed using the Statistical Package for Social Sciences (SPSS) version 21.0. Among the groups, demographic and clinical variables will be compared with independent sample t-test for continuous variables and a chi-square test for categorical variables. The significance level will be set as p<0.05.

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: What Daily Activities Increase the Risk of Falling in Chronic Obstructive Pulmonary Disease Patients?
Actual Study Start Date : August 31, 2019
Actual Primary Completion Date : October 22, 2019
Actual Study Completion Date : December 3, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group-1

The patients were classified based on the frequency of falls in the last 12 months.

Group-1 consists of COPD patients whose have at least one fall (fallers)

Other: No intervention
There is no intervention.

Group-2

The patients were classified based on the frequency of falls in the last 12 months.

Group-2 consists of COPD patients whose have no history of falls (non-fallers).

Other: No intervention
There is no intervention.




Primary Outcome Measures :
  1. Activities-Specific Balance Confidence scale [ Time Frame: Baseline ]
    Activities-Specific Balance Confidence (ABC) scale will be used for evaluating the confidence in maintaining the balance in activities daily living. It provides information on the level of concern about falls during16 community-based and home-based activities. Scale scores between 0 (unsafe) to 100 (completely safe) and the total score (0-1600) is divided by 16 to obtain an individual's ABC score, with higher scores indicating greater balance confidence. In patients with COPD, the ABC scale has demonstrated construct validity as well as criterion validity for falls. In addition, the participants will be also questioned concerning the occurrence of falls and the risk of falling during the activity in each item of the ABC scale.


Secondary Outcome Measures :
  1. Fall frequency [ Time Frame: Baseline ]
    Fall frequency will be investigated by asking patients to report any fall event in the last one month and the last 12-months. Participants will be asked: "Have you had any fall including a slip or trip in which you lost your balance and landed on the floor or ground or lower level?" Details about the circumstances of the fall and any resultant injury will be questioned.

  2. Berg Balance Scale [ Time Frame: Baseline ]
    Berg Balance Scale (BBS) will be used to assess the balance and determine the risk of falling in participants. It consists of 14-item evaluating a patient's ability to safely balance during a series of physical tasks. Scale scores between 0 (unable/unsafe) to 4 (independent/safe) and the total score ranges from 0 to 56, with higher scores indicating better balance control. The BBS has been demonstrated construct validity in patients with COPD.

  3. London Chest Activity of Daily Living scale [ Time Frame: Baseline ]
    London Chest Activity of Daily Living (LCADL) scale is used for assessing the level of dyspnea during daily activities. It is a 15-item scale comprised 4 domains: self-care (4 items), domestic (6 items), physical (2 items), and leisure (3 items). Each item scored between 0 (I wouldn't do it anyway) to 5 (I need help in doing this or someone to do it for me) and the total score ranges from 0 to 75, with higher scores indicating a more significant limitation in daily activities. The LCADL scale is a reliable, valid, and responsive instrument to assess limitations in performing daily activities in COPD patients. asked to rate each item in terms of risk of falling using a five-point scale, where 1=very low, 2=low, 3=moderate, 4=high, and 5=very high.

  4. The COPD Assessment Test [ Time Frame: Baseline ]
    The COPD Assessment Test (CAT) will be used for evaluating the global impacts of COPD symptoms on overall health status. Each item scores between 0 to 5 and the total score ranges from 0 to 40, with higher scores indicating the more severe impact of COPD on health status.

  5. The strength of quadriceps femoris [ Time Frame: Baseline ]
    The strength of quadriceps femoris of both sides will be measured with a hand-held dynamometer (kg.N-1) ''Nicholas Manual Muscle Tester" (model 01160, The Lafayette Instrument Company, Lafayette, Indiana). Each limb will assessed 3 times, with a recovery period of 30 seconds and the mean value will be calculated.

  6. The Modified Medical Research Council Dyspnea scale [ Time Frame: Baseline ]
    The Modified Medical Research Council Dyspnea (mMRC) scale will be used to determine how dyspnea limits the patients' daily activities performance. Itis a five-level rating scale consisting of just five items containing statements about the impact of dyspnea on the patients' daily activities performance and leading to a grade from 1 to 5. Higher scores indicate a greater impact of dyspnea on the patients' daily activities performance.

  7. Six-Minute Walking Test (6MWT) [ Time Frame: Baseline ]
    Six-Minute Walking Test (6MWT) is a reliable and valid test for evaluating functional capacity. Two 6MWTs will be performed according to the guidelines of the American Thoracic Society. The distance in meters covered over the 6 minutes of the test (6MWD) will be recorded.



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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All participants will be patients with COPD diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines were recruited from Istanbul University, Department of Chest Diseases.
Criteria

Inclusion Criteria:

  1. stable disease (no severe exacerbations in the prior 3 months)
  2. ability to walk independently
  3. ability to read and write in Turkish
  4. able to follow simple instructions
  5. no pathology in visual ability and hearing

Exclusion Criteria:

  1. a history of specific balance problems (i.e., diagnosed vestibular or neurological disorder)
  2. severe musculoskeletal, neurological or cardiovascular disorders that limit mobility
  3. use of medication(s) that may increase the risk of falls
  4. participate in pulmonary rehabilitation in the lasts six months

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): NCT04074499


Locations
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Turkey
Istanbul University-Cerrahpasa
Istanbul, Bakırkoy, Turkey, 34147
Sponsors and Collaborators
Istanbul University-Cerrahpasa
Investigators
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Principal Investigator: Tansu Birinci, MSc Istanbul University-Cerrahpasa
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Responsible Party: Tansu Birinci, PT, MSc Research Assistant, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier: NCT04074499    
Other Study ID Numbers: 459535
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases