NCT05752370

Brief Summary

The primary aim of this pilot randomized controlled trial is to determine feasibility of the proposed pulmonary rehabilitation intervention.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

March 5, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

February 13, 2023

Last Update Submit

September 22, 2023

Conditions

Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Changes in 1-minute sit to stand test

    maximum number of sit to stand cycles in 1 minute

    1 month

Secondary Outcomes (9)

  • Changes in 30-second sit to stand test

    1 month, 3 month

  • Changes in respiratory symptoms

    1 month, 3 months

  • Changes in mood

    1 month, 3 month

  • changes in quality of life

    1 month, 3 month

  • Changes in lung function

    1 month, 3 month

  • +4 more secondary outcomes

Other Outcomes (1)

  • Qualitative interview

    Upon completion of study, or when patients end participation in the study

Study Arms (2)

High flow oxygen

EXPERIMENTAL

High flow nasal oxygen

Device: High flow oxygen

Usual care

ACTIVE COMPARATOR

room air or normal flow oxygen

Other: Usual care

Interventions

High flow oxygenDEVICE

Use of HFO

High flow oxygen
Usual careOTHER

Room air or normal flow oxygen

Usual care

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and above
  • Presence of exertional hypoxemia during 1-minute sit-to-stand test
  • diagnosis of acute COPD exacerbation or Covid-19 pneumonia or exacerbation of bronchiectasis or exacerbation of interstitial lung disease
  • physically fit to participate in exercise therapy as determined by both the patient's physician and physiotherapist

You may not qualify if:

  • uncontrolled severe medical conditions
  • currently enrolled in a pulmonary rehabilitation trial
  • unsuitable for randomization as determined by the patient's physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

RECRUITING

Study Officials

  • Yingjuan Mok

    Changi General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingjuan Mok, MBBS

CONTACT

69366603mok.yingjuan@singhealth.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2023

First Posted

March 2, 2023

Study Start

March 5, 2023

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

September 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)