NCT05383950

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, cardiac, or geriatric 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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

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

May 1, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

May 1, 2022

Last Update Submit

May 20, 2022

Conditions

Pulmonary RehabilitationCardiac Rehabilitation

Outcome Measures

Primary Outcomes (3)

  • change of 6 minutes walk distance at 12 weeks (Chronic respiratory disease group)

    The distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.

    12 weeks

  • change of maximal oxygen consumption (VO2max) at 12 weeks (Chronic respiratory disease group, Chronic cardiac disease group)

    The maximum rate of oxygen consumption measured during incremental exercise test (cardiopulmonary exercise test).

    12 weeks

  • change of frailty index at 12 weeks (Chronic geriatric disease group)

    The frailty index is defined as the proportion of deficits present in an individual out of the total number of age-related health variables considered. Frailty Index (FI) = (number of health deficits present) ÷ (number of health deficits measured) For example, a person with 20 of 40 deficits collected has an FI score of 20/40 = 0.5 The frailty index ranges 0 (best performance) to 1 (worst performance).

    12 weeks

Secondary Outcomes (13)

  • change from dyspnea symptom at 12 weeks (Chronic respiratory disease group, Chronic geriatric disease group)

    12 weeks

  • change from dyspnea symptom at 12 weeks (Chronic cardiac disease group, Chronic geriatric disease group)

    12 weeks

  • Change of EuroQol 5-dimension 5-level (EQ-5D-5L) score at 12 weeks (all groups)

    12 weeks

  • change of Korean Health-related Quality of Life Instrument with 8 Items (HINT-8) score at 12 weeks (all groups)

    12 weeks

  • change of muscle strength at 12 weeks (all groups)

    12 weeks

  • +8 more secondary outcomes

Study Arms (1)

smartphone application based 12-week pulmonary or cardiac rehabilitation

EXPERIMENTAL
Device: smartphone application

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, cardiac, or geriatric diseases.

smartphone application based 12-week pulmonary or cardiac rehabilitation

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 I
  • adults between 20 years and 80 or years
  • Chronic respiratory disease
  • FEV1/FVC \< 0.7 in pulmonary function test
  • bronchiectasis in more than one lobe on chest computed tomography
  • FVC of DLCO \< 0.8 of predicted value in pulmonary function test
  • Chronic cardiac disease
  • Reperfusion Therapy for angina pectoris or myocardial infarction
  • Heart failure with reduced ejection fraction (LVEF \< 50%)
  • Chronic geriatric disease
  • Ages between 60 and 80 years
  • Clinical frailty scale between 1 and 4

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, University of Ulsan College of Medicine

Seoul, Songpa, 05505, South Korea

RECRUITING

Related Publications (1)

  • Chung C, Kim AR, Kim D, Kwon H, Lee SH, Jang IY, Jo MW, Kang DY, Lee SW. Smartphone application-based rehabilitation in patients with chronic respiratory and cardiovascular diseases. Sci Rep. 2024 Feb 6;14(1):3018. doi: 10.1038/s41598-024-53583-2.

    PMID: 38321153DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 1, 2022

First Posted

May 20, 2022

Study Start

June 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 26, 2022

Record last verified: 2022-05

Locations

KR(1)