NCT06579872

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Dec 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Dec 2024Dec 2026

First Submitted

Initial submission to the registry

August 28, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

December 12, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

August 28, 2024

Last Update Submit

February 25, 2026

Conditions

Keywords

chronic obstructive pulmonary diseaseplantar pressurepulmonary rehabilitation6-minute walk test

Outcome Measures

Primary Outcomes (1)

  • plantar pressure

    The correlation between foot pressure indices and functional tests

    20 minutes

Secondary Outcomes (2)

  • cardiopulmonary function

    20 minutes

  • self-feedback questionnaires

    20 minutes

Study Arms (2)

Case group

Patients diagnosed with pre-COPD or COPD.

Other: plantar pressure

Control group

Healthy individuals without cardiopulmonary disease.

Other: plantar pressure

Interventions

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

Case groupControl group

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ke-Yun Chao, PhD

    Fu Jen Catholic University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Group leader of Respiratory Therapists

Study Record Dates

First Submitted

August 28, 2024

First Posted

August 30, 2024

Study Start

December 12, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations