NCT05435885

Brief Summary

The purpose of this study is to confirm the effectiveness of a mobile messenger-based home tele-rehabilitation protocol in patients who have undergone lung resection surgery. By analyzing the difference from the existing postoperative pulmonary rehabilitation, the investigators would like to propose a new pulmonary tele-rehabilitation protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

July 25, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 17, 2025

Completed
Last Updated

June 17, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

June 23, 2022

Results QC Date

April 9, 2025

Last Update Submit

May 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in VO2 Peak (Peak Oxygen Uptake, mL/kg/Min) on the CardioPulmonary Exercise Test(CPET) After 4 Weeks Intervention

    Cardiopulmonary exercise test (CPET) also referred to as a VO2 (oxygen consumption) test, is a specialized type of stress test or exercise test that measures participants exercise ability.

    Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)

Secondary Outcomes (11)

  • Ventilatory Efficiency (VE/VCO₂ Slope)

    Immediately After Rehabilitation and at 4-Week Follow-Up

  • Maximal Inspiratory Pressure (MIP)

    Immediately After Rehabilitation and at 4-Week Follow-Up

  • Skeletal Muscle Index (SMI)

    Immediately After Rehabilitation and at 4-Week Follow-Up

  • Hospital Anxiety and Depression Scale (HADS)

    Immediately After Rehabilitation and at 4-Week Follow-Up

  • EQ-5D (EuroQol-5 Dimension)

    Immediately After Rehabilitation and at 4-Week Follow-Up

  • +6 more secondary outcomes

Study Arms (2)

Tele-rehabilitation group

EXPERIMENTAL

The Tele-rehabilitation group performs 12 training sessions during four weeks. (3 sessions/week)

Other: Pulmonary Tele-Rehabilitation

Control group

OTHER

The control group receives usual care with only one educational session.

Other: Control (Education)

Interventions

12 supervised training sessions via a specific mobile messenger during four weeks. (3 sessions/week)

Tele-rehabilitation group

Usual care with only one educational session.

Control group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • A person who is suspected of lung cancer and is scheduled to undergo a thoracoscopic lung resection surgery.
  • men and women the age ≥65 years.
  • A person who understands the course of the clinical trial and signs the informed consent form.

You may not qualify if:

  • Patients whose activity is restricted due to other diseases (e.g. osteoarthritis, spinal disease, cerebral infarction, etc.)
  • Patients who cannot test bioimpedance analysis due to the insertion of artificial pacemakers and defibrillators
  • A person who has difficulty judging himself/herself due to dementia, etc
  • Those enrolled in other clinical trials
  • A person deemed inappropriate to participate in this clinical trial under the judgement of the investigator.
  • A person who cannot use mobile messenger

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PusanNUH

Pusan, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Results Point of Contact

Title
Dr. Sanghun Kim
Organization
Department of Rehabilitation Medicine, Pusan National University Hospital

Study Officials

  • Sang Hun Kim, M.D.,Ph.D.

    Pusan National University Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2022

First Posted

June 28, 2022

Study Start

July 25, 2022

Primary Completion

February 16, 2024

Study Completion

February 16, 2024

Last Updated

June 17, 2025

Results First Posted

June 17, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations