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

Association Between Cardiopulmonary Function, Mobility, Walking Ability, and Plantar Pressure Changes in Patients With Chronic Obstructive Pulmonary Disease: A Case-Control Study

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: plantar pressure

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Ke-Yun Chao, PhD; Phone Number: +886-905-301-879; Email: C00152@mail.fjuh.fju.edu.tw

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 24352
    • Recruiting
    • Fu Jen Catholic University Hospital, Fu Jen Catholic University
    • Contact: Ke-Yun Chao, PhD; Phone Number: +886-905-301-879; Email: ck_qq@hotmail.com
    • Principal Investigator: Ke-Yun Chao, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The control group consists of healthy individuals, while the case group includes those diagnosed with COPD or pre-COPD.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case group; Patients diagnosed with pre-COPD or COPD.	Other: plantar pressure; foot pressure analysis, cardiopulmonary function, and mobility in patients with chronic respiratory diseases
Control group; Healthy individuals without cardiopulmonary disease.	Other: plantar pressure; foot pressure analysis, cardiopulmonary function, and mobility in patients with chronic respiratory diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plantar pressure	The correlation between foot pressure indices and functional tests	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiopulmonary function	The correlation between foot pressure indices and cardiopulmonary function	20 minutes
self-feedback questionnaires	The correlation between foot pressure indices and self-feedback questionnaires	20 minutes

Collaborators and Investigators

• Sponsor: Fu Jen Catholic University
• Investigators: Principal Investigator: Ke-Yun Chao, PhD, Fu Jen Catholic University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: pulmonary rehabilitation; 6-minute walk test; chronic obstructive pulmonary disease; plantar pressure
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: FJUH113361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No