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Recruiting NCT06579872

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

Observational Chronic Obstructive Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: plantar pressure.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease. Basic parameters: 45 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other plantar pressure
    foot pressure analysis, cardiopulmonary function, and mobility in patients with chronic respiratory diseases

Primary outcome measures

  • plantar pressure [Time frame: 20 minutes]
Secondary outcome measures (2)
  • cardiopulmonary function [Time frame: 20 minutes]
  • self-feedback questionnaires [Time frame: 20 minutes]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Taiwan · 1 center
  • Fu Jen Catholic University Hospital, Fu Jen Catholic University — New Taipei City

Identifiers

NCT: NCT06579872 · FJUH113361

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗