Efficacy of Smartphone Application Based Rehabilitations in Patients With Chronic Respiratory or Cardiovascular Disease

Sponsor
Asan Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05610358
Collaborator
(none)
162
1
2
24
6.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: smartphone application
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
162 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Efficacy of Smartphone Application Based Rehabilitations in Patients With Chronic Respiratory or Cardiovascular Disease
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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

Device: smartphone application
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.

No Intervention: Control

Participants in the control group will be educated rehabilitation program at the time of enrolment and they will practice self-managed rehabilitation for 12 weeks.

Outcome Measures

Primary Outcome Measures

  1. change of maximal oxygen consumption (VO2max) [12 weeks]

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

Secondary Outcome Measures

  1. change of dyspnea symptom (Chronic respiratory disease group) [12 weeks]

    Dyspnea symptom is measured according to the Modified Medical Research Council (mMRC) Dyspnea Scale. The mMRC scale is from 0 to 4: 0: no breathlessness except on strenuous exercise shortness of breath when hurrying on the level or walking up a slight hill walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level stops for breath after walking ∼100 m or after few minutes on the level too breathless to leave the house, or breathless when dressing or undressing

  2. change of dyspnea symptom (Chronic cardiovascular disease group) [12 weeks]

    Dyspnea symptom is measured according to the New York Heart Association Functional Classification (NYHA class). The NYHA class is from I to IV: Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation (feeling heart beats), or dyspnea (shortness of breath). Class II(Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III(Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV(Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.

  3. Change of EuroQol 5-dimension 5-level (EQ-5D-5L) score [12 weeks]

    A questionnaire assessing health related quality of life on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each item is scored 1-5, yielding a total between 5 and 25. The scores range from 5 (best performance) to 25 (worst performance).

  4. change of Korean Health-related Quality of Life Instrument with 8 Items (HINT-8) score [12 weeks]

    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).

  5. change of hand grip strength [12 weeks]

    The muscle strength measures hand grip strength. The cut-off value for sarcopenia is < 30 kg

  6. change of limb muscle mass [12 weeks]

    The muscle mass is measured using the Bioelectrical Impedance Analysis. The cut off value for sarcopenia is < 7.26 kg/m^2.

  7. change of forced expiratory volume in one second (FEV1) (Chronic respiratory disease group) [12 weeks]

    The forced expiratory volume in one second (FEV1) is measured using spirometry. The value will be presented in % predicted value.

  8. change of forced vital capacity (FVC) (Chronic respiratory disease group) [12 weeks]

    The forced vital capacity (FVC) is measured using spirometry. The value will be presented in % predicted value.

  9. change of diffusing capacity of the lung for carbon monoxide (DLCO) (Chronic respiratory disease group) [12 weeks]

    The diffusing capacity of the lung for carbon monoxide (DLCO) is measured using single breath holding method. The value will be presented in % predicted value.

  10. Change of chest pain symptom (Chronic cardiovascular disease group) [12 weeks]

    Chest pain symptom is measured according to the Canadian Cardiovascular Society grading of angina pectoris (CCS angina grade). The CCS angina grade is from I to IV: Grade I: Angina with strenuous/rapid/prolonged exertion at work or recreation only; no angina with ordinary physical activity, e.g. walking, climbing stairs Grade II: Ordinary activity slightly limited: angina with walking/climbing stairs rapidly, walking uphill, walking or stair climbing after meals, in cold/wind, under emotional stress, during few hours after awakening, walking >2 blocks on level ground, or climbing >1 flight of stairs at normal pace and normal conditions Grade III: Marked limitation of ordinary physical activity: angina with walking 1-2 blocks on level ground or climbing 1 flight of stairs at normal pace and normal conditions Grade IV: Inability to carry on any physical activity without discomfort; anginal syndrome may be present at rest

  11. change of exercise duration in cardiopulmonary exercise test (Chronic cardiovascular disease group) [12 weeks]

    This test measures total exercise duration.

  12. change of exercise capacity in cardiopulmonary exercise test (Chronic cardiovascular disease group) [12 weeks]

    This test measures metabolic equivalents (METs).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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%)

Exclusion Criteria:
  • history of acute exacerbation within 4 weeks

  • unable to comply rehabilitation program

  • not suitable for study on decision by duty physician

  • no consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asan Medical Center Seoul Korea, Republic of 05505

Sponsors and Collaborators

  • Asan Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sei Won Lee, professor, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT05610358
Other Study ID Numbers:
  • 2022-1460
First Posted:
Nov 9, 2022
Last Update Posted:
Nov 9, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2022