Association Between Cardiopulmonary Function and Plantar Pressure in Patients With Chronic Obstructive Pulmonary Disease

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: plantar pressure

• Registration Number: NCT06579872
• Lead Sponsor: Fu Jen Catholic University

Brief Summary

It aims to understand the differences in everyday mobility and activity capabilities among patients with varying disease progression and severity, to serve as reference indicators for evaluating the effectiveness of pulmonary rehabilitation exercise training.

Detailed Description

Background： Chronic respiratory diseases and Chronic Obstructive Pulmonary Disease (COPD) are major causes of chronic illness and death worldwide. Patients with chronic respiratory diseases experience muscle weakness and respiratory difficulties, leading to restricted physical activity, decreased functional capacity, exercise intolerance, and limb muscle atrophy. While exercise training can effectively improve limb strength, there is a lack of objective data exploring different disease progressions and clinical cardiopulmonary limitations, hence this study utilizes plantar pressure distribution to research lower limb strength and cardiopulmonary function in patients, hoping to identify relevant indicators for necessary exercise training.

Methods： The study plans to enroll 60 participants, divided into two groups (30 in the control group and 30 in the case group) matched 1:1. The study will be conducted at the pulmonary rehabilitation therapy room on the sixth floor of Fu-Jen Catholic University Hospital. In addition to basic demographic and clinical physiological parameters, all participants will undergo the 6-minute walk test, the timed up and go test, simple pulmonary function tests, body composition analysis, and statistical analysis.

Effect： The trial is expected to effectively determine which patients require exercise training based on the correlation between plantar pressure analysis and results from the 6-minute walk test and timed up and go test. These results are anticipated to correlate positively with disease severity.

Study Timeline

• Study First Submitted: 2024-08-28
• Study First Submitted QC: 2024-08-28
• Study First Posted: 2024-08-30
• Status Verified: 2024-12
• Study Start: 2024-12-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age between 45 and 65 years
• Patients with chronic respiratory diseases requiring pulmonary rehabilitation
• Signed informed consent form

Exclusion Criteria

• Current tracheostomy
• Home use of oxygen therapy or ventilators
• Diagnosed with severe left heart failure (NYHA III-IV)
• Patients diagnosed with neuromuscular diseases
• Had an acute exacerbation of COPD in the past three months
• Unable to perform cardiopulmonary exercise testing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case group	plantar pressure	Patients diagnosed with pre-COPD or COPD.
Control group	plantar pressure	Healthy individuals without cardiopulmonary disease.

Primary Outcome Measures

Name	Time	Method
plantar pressure	20 minutes	The correlation between foot pressure indices and functional tests

Secondary Outcome Measures

Name	Time	Method
self-feedback questionnaires	20 minutes	The correlation between foot pressure indices and self-feedback questionnaires
cardiopulmonary function	20 minutes	The correlation between foot pressure indices and cardiopulmonary function

Trial Locations

Locations (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University; 🇨🇳 New Taipei City, Taiwan