MedDataX Logo

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

NCT ID: NCT06579872

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-12

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

chronic obstructive pulmonary disease plantar pressure pulmonary rehabilitation 6-minute walk test

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Case group

Patients diagnosed with pre-COPD or COPD.

plantar pressure

Intervention Type OTHER

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

Control group

Healthy individuals without cardiopulmonary disease.

plantar pressure

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

plantar pressure

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fu Jen Catholic University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ke-Yun, Chao

Group leader of Respiratory Therapists

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ke-Yun Chao, PhD

Role: PRINCIPAL_INVESTIGATOR

Fu Jen Catholic University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ke-Yun Chao, PhD

Role: CONTACT

Phone: +886-905-301-879

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ke-Yun Chao, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FJUH113361

Identifier Type: -

Identifier Source: org_study_id