NCT06112730

Brief Summary

The aim of this study is to investigate the nutritional status of patients with chronic pulmonary disease undergoing regular outpatient pulmonary rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 29, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2024

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

October 29, 2023

Last Update Submit

February 25, 2026

Conditions

Chronic Lung Disease

Keywords

Chronic obstructive pulmonary diseasePulmonary rehabilitationNutritional supplementationIndirect calorimetry

Outcome Measures

Primary Outcomes (1)

  • Resting energy expenditure

    Basal metabolic rate

    15 minutes

Study Arms (2)

Standard pulmonnary rehabilitation group

ACTIVE COMPARATOR

Received routine pulmonnary rehabilitation

Other: Standard pulmonnary rehabilitation

Nutritional supplementation intervention group

EXPERIMENTAL

Received regular pulmonnary rehabilitation plus healthy dietary recommendations

Other: Nutritional supplementation intervention

Interventions

Standard pulmonnary rehabilitationOTHER

Undergo routine pulmonary rehabilitation without dietary intervention

Standard pulmonnary rehabilitation group
Nutritional supplementation interventionOTHER

Receive personalized dietary guidelines based on indirect calorimetry assessment

Nutritional supplementation intervention group

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 45 and 80 years
  • A written informed consent
  • Pre-COPD or COPD stages I-IV as per the 2023 GOLD guidelines
  • Recieved pulmonary rehabilitation at least three months
  • Unwilling to nutritional outpatient assessment

You may not qualify if:

  • Diagnosed with neuromuscular diseases
  • Emergency room visits or hospitalizations for exacerbation of respiratory disease within three months
  • Inability to cooperate with cardiopulmonary exercise testing
  • Significant malnutrition or low BMI

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

Location

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Group leader of Respiratory Therapists

Study Record Dates

First Submitted

October 29, 2023

First Posted

November 1, 2023

Study Start

October 30, 2023

Primary Completion

June 24, 2024

Study Completion

June 24, 2024

Last Updated

February 27, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)