NCT05610358

Brief Summary

In Republic of Korea, it is not easy to practice standard pulmonary rehabilitation (PR) or cardiac rehabilitation (CR). In this study, the investigators will provide newly developed smartphone application to patients with chronic respiratory or cardiovascular diseases. The investigators want to confirm whether participants, who perform smartphone application based 12-week PR or CR program, present improved exercise capacity, dyspnea symptom, muscle strength, or quality of life.

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
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 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

November 3, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

November 3, 2022

Last Update Submit

July 1, 2023

Conditions

Pulmonary RehabilitationCardiac Rehabilitation

Outcome Measures

Primary Outcomes (3)

  • change of maximal oxygen consumption (VO2max)

    The maximal oxygen consumption (VO2max) is measured during incremental exercise test (cardiopulmonary exercise test).

    12 weeks

  • Change of Chronic obstructive pulmonary disease (COPD) assessment Test (CAT) (Chronic respiratory disease group)

    Self reported Patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dyspnea, chest tightness) on health status. Each item is scored 0-5, yielding a total between 0 and 40

    12 weeks

  • change of Korean Health-related Quality of Life Instrument with 8 Items (HINT-8) score (Chronic cardiovascular disease group)

    A questionnaire assessing health related quality of life on 4 health dimensions (physical, mental, social, positive health dimension). Each item is scored 1-4, yielding a total between 8 and 40. The scores range from 8 (best performance) to 40 (worst performance).

    12 weeks

Secondary Outcomes (12)

  • change of dyspnea symptom (Chronic respiratory disease group)

    12 weeks

  • change of dyspnea symptom (Chronic cardiovascular disease group)

    12 weeks

  • Change of EuroQol 5-dimension 5-level (EQ-5D-5L) score

    12 weeks

  • change of Korean Health-related Quality of Life Instrument with 8 Items (HINT-8) score (Chronic respiratory disease group)

    12 weeks

  • change of hand grip strength

    12 weeks

  • +7 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in the intervention group will be provided the smartphone application and they will practice application based rehabilitation for 12 weeks.

Device: smartphone application

Control

NO INTERVENTION

Participants in the control group will not practice rehabilitation program.

Interventions

smartphone applicationDEVICE

In this study, the investigators will provide smartphone application based 12-week pulmonary or cardiac rehabilitation program to patients with chronic respiratory or cardiovascular diseases.

Intervention

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dyspnea symptom \>= mMRC 1 or NYHA II
  • adults between 20 years and 80 or years
  • Chronic respiratory disease
  • FEV1/FVC \< 0.7 or FEV1\< 0.8 of predicted value in pulmonary function test
  • bronchiectasis in more than one lobe on chest computed tomography
  • FVC or DLCO \< 0.8 of predicted value in pulmonary function test
  • Chronic cardiovascular disease
  • Reperfusion Therapy for angina pectoris or myocardial infarction
  • Heart failure with reduced ejection fraction (LVEF \< 50%)

You may not qualify if:

  • history of acute exacerbation within 4 weeks
  • unable to comply rehabilitation program
  • not suitable for study on decision by duty physician
  • no consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Related Publications (2)

  • Chung C, Kim AR, Kang DY, Kim S, Oh J, Kim HJ, Park B, Lee SH, Kim D, Kwon H, Jo MW, Lee SW. Clinical Efficacy of Smartphone App-Based Pulmonary Rehabilitation in Chronic Respiratory Diseases: Randomized Controlled and Feasibility Trials. J Med Internet Res. 2025 Nov 28;27:e76801. doi: 10.2196/76801.

    PMID: 41313804DERIVED

  • Chung C, Kim AR, Jang IY, Jo MW, Lee S, Kim D, Kwon H, Kang DY, Lee SW. Smartphone application-based rehabilitation in patients with chronic respiratory and cardiovascular diseases: a randomised controlled trial study protocol. BMJ Open. 2023 Sep 20;13(9):e072698. doi: 10.1136/bmjopen-2023-072698.

    PMID: 37730392DERIVED

Central Study Contacts

Sei Won Lee, MD PhD

CONTACT

82-2-3010-3990iseiwon@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 3, 2022

First Posted

November 9, 2022

Study Start

April 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

July 5, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

The datasets used and/or analysed during the current study will be available from the principal investigator on reasonable request.

Locations

KR(1)