Determinants of Balance in Patients With Chronic Obstructive Pulmonary Disease

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Balance Assessment; Other: Pulmonary function test; Other: Respiratory muscle strength test; Other: Peripheral muscle strength test; Other: 6-minute walk test; Other: Cognitive assessment

• Registration Number: NCT05771506
• Lead Sponsor: Biruni University

Brief Summary

The primary aim of our study is to examine the relationship between balance and respiratory function, respiratory and peripheral muscle strength, functional capacity, and cognitive function in patients with Chronic Obstructive Pulmonary Disease (COPD). The secondary aim of our study is to compare respiratory function, respiratory and peripheral muscle strength, functional capacity, balance, and cognitive functions of COPD patients and healthy individuals. This study will examine and record the participant's sociodemographic information and medical records. Balance, respiratory function, respiratory and peripheral muscle strength, functional capacity, and cognitive function will be assessed. Since the patients are included in this study, no intervention will be made, no additional tests will be performed, or no changes will be made in the routine treatments of the patients during the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-16
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-04
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Being diagnosed with COPD in accordance with the GOLD criteria
• Being between the ages of 40-65
• To be able to speak, read, understand, and cooperate in Turkish
• Being a volunteer to participate in the study

COPD Group

Exclusion Criteria

• Having a COPD exacerbation in the last 8 weeks and/or having an unstable clinical condition
• Having a diagnosed vision, hearing, or neurological disease that may affect balance
• Having any other neurological, orthopedic, cardiovascular, thoracic, or metabolic disease or pathological condition that would affect assessments
• Resting saturation below 90% during exercise tests
• Being on long-term oxygen therapy

Control Group Inclusion Criteria:

• Being between the ages of 40-65
• To be able to speak, read, understand, and cooperate in Turkish
• Being a volunteer to participate in the study

Control Group Exclusion Criteria:

• Having a diagnosed vision, hearing, or neurological disease that may affect balance
• Having any other neurological, orthopedic, cardiovascular, thoracic, or metabolic disease or pathological condition that would affect assessments
• Resting saturation below 90% during exercise tests

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD Group	6-minute walk test	Balance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment
COPD Group	Respiratory muscle strength test	Balance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment
COPD Group	Peripheral muscle strength test	Balance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment
Control Group	Cognitive assessment	Balance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment
Control Group	Balance Assessment	Balance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment
Control Group	Pulmonary function test	Balance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment
Control Group	Peripheral muscle strength test	Balance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment
COPD Group	Balance Assessment	Balance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment
COPD Group	Pulmonary function test	Balance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment
COPD Group	Cognitive assessment	Balance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment
Control Group	Respiratory muscle strength test	Balance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment
Control Group	6-minute walk test	Balance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment

Primary Outcome Measures

Name	Time	Method
Forced vital capacity (FVC)	10-15 minutes
Maximal inspiratory pressure (MIP)	15-20 minutes
Quadriceps muscle strength	15-20 minutes
MoCA test	10-15 minutes
FEV1/FVC	10-15 minutes
6-minute walk test	15-20 minutes
Sensory integration test of balance: Composite score	20-30 minutes
Forced expiratory volume in 1 second (FEV1)	10-15 minutes
Peak expiratory flow (PEF)	10-15 minutes
Stability limits test: Overall score	15-20 minutes
Maximal expiratory pressure (MEP)	15-20 minutes
Postural stability test: Overall score	15-20 minutes
Forced expiratory flow 25-75% (FEF25-75)	10-15 minutes

Trial Locations

Locations (1)

Biruni University; 🇹🇷 Istanbul, Turkey