NCT04074499

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

August 31, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2019

Completed
Last Updated

October 8, 2024

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

August 28, 2019

Last Update Submit

October 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Activities-Specific Balance Confidence scale

    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.

    Baseline

Secondary Outcomes (7)

  • Fall frequency

    Baseline

  • Berg Balance Scale

    Baseline

  • London Chest Activity of Daily Living scale

    Baseline

  • The COPD Assessment Test

    Baseline

  • The strength of quadriceps femoris

    Baseline

  • +2 more secondary outcomes

Study Arms (2)

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

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

Interventions

There is no intervention.

Group-1Group-2

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Tansu Birinci, MSc

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, MSc Research Assistant

Study Record Dates

First Submitted

August 28, 2019

First Posted

August 30, 2019

Study Start

August 31, 2019

Primary Completion

October 22, 2019

Study Completion

December 3, 2019

Last Updated

October 8, 2024

Record last verified: 2020-03

Locations