Clinical trial NCT06579872: Association Between Cardiopulmonary Function and Plantar Pressure in Patients With Chronic Obstructive Pulmonary Disease
Official title: Association Between Cardiopulmonary Function, Mobility, Walking Ability, and Plantar Pressure Changes in Patients With Chronic Obstructive Pulmonary Disease: A Case-Control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
plantar pressure
pulmonary rehabilitation
6-minute walk test
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: plantar pressure
timeFrame: 20 minutes
Secondary outcomes:
measure: cardiopulmonary function
timeFrame: 20 minutes
measure: self-feedback questionnaires
timeFrame: 20 minutes
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study officials:
affiliation: Fu Jen Catholic University Hospital
name: Ke-Yun Chao, PhD
role: PRINCIPAL_INVESTIGATOR
References: