Clinical trial NCT04074499: The Risk of Falling in Patients with Chronic Obstructive Pulmonary Disease
Official title: What Daily Activities Increase the Risk of Falling in Chronic Obstructive Pulmonary Disease Patients?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Fall
Balance; Distorted
Activity, Motor
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 28
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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

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.

Eligibility 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

Primary outcomes:
measure: Activities-Specific Balance Confidence scale
timeFrame: Baseline
Secondary outcomes:
measure: Fall frequency
timeFrame: Baseline
measure: Berg Balance Scale
timeFrame: Baseline
measure: London Chest Activity of Daily Living scale
timeFrame: Baseline
measure: The COPD Assessment Test
timeFrame: Baseline
measure: The strength of quadriceps femoris
timeFrame: Baseline
measure: The Modified Medical Research Council Dyspnea scale
timeFrame: Baseline
measure: Six-Minute Walking Test (6MWT)
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Bakırkoy
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Tansu Birinci, MSc
role: PRINCIPAL_INVESTIGATOR
References: