MedPath

Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases

Not Applicable
Completed
Conditions
Lung Cancer
Respiratory Disease
COPD
Interventions
Other: Fixed respiratory rehabilitation
Other: Responsive respiratory rehabilitation
Registration Number
NCT03432117
Lead Sponsor
Asan Medical Center
Brief Summary

This trial is multicenter prospective study to evaluate clinical efficacy of respiratory rehabilitation personalized mobile services for respiratory disease.

Detailed Description

Patients with Lung Cancer or COPD who need respiratory rehabilitation were enrolled in this trial. The subjets were randomized to 3 group(A: Fixed respiratory rehabilitation program group, B: Mixed respiratory rehabilitation program group(Fixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks) and C: Control group(Ordinary rehabilitation service of the site)).

Patients in Group A\&B were provided with mobile application and wearable O2 saturation machine and mobile application monitors physical activity and provides

1. how to do stretching, weight training with The-ra Band

2. daily and weekly target of exercise

3. alarm algorithms depending on patient's respiratory status(purse rate and O2 saturation)

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
179
Inclusion Criteria
  • Patients with Lung cancer or COPD

  • Patients with FEV1<80% or FVC<80% in Pulmonary function test

    • In case of COPD, post-bronchodilator FEV1 or FVC will be used.
    • Exceptionally Lung Cancer patients with operation, FEV1>80% or FVC>80% will be permitted
  • The distance walked for 6 minutes in 6-minute walk test ≥ 150 m

  • Patients with android phone

  • Patients who voluntarily agree to study participation and provide written informed consent form

Read More
Exclusion Criteria
  • Patients with diseases which could be cause of death or significant disability for 1 year after study enrollment.
  • Patients with diseases that are difficult to walk or improve walking at screening
  • Patients with significant diseases which are difficult to include in this study in accordance with the investigator's judgment
  • Patients who are illiterate or have communication limitations
  • Patients who have a difficulty to complete a questionnaire or are uncooperative due to deterioration of recognition function
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Mixed respiratory rehabilitation program(B)Fixed respiratory rehabilitationFixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks
Mixed respiratory rehabilitation program(B)Responsive respiratory rehabilitationFixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks
Fixed respiratory rehabilitation program(A)Fixed respiratory rehabilitationrespiratory rehabilitation program for 12 weeks
Primary Outcome Measures
NameTimeMethod
change from baseline in real distance walked for 6 minutes12 weeks
change from baseline in Modified Medical Research Council dyspnea score12 weeks

The MMRC dyspnea scale is a five-option grading system. The scale measures a person's limitation base on a scale of 0-4 and uses the final value to determine how much disability is caused by shortness of breath.

change from baseline in COPD Assessment Test(CAT) score12 weeks

The CAT is a validated, short and simple subject completed questionnaire which has been developed for use in routine clinical practice to measure the health status of subjects with COPD. Subjects are scored on eight items (cough, phlegm, chest tightness, breathlessness, activity limitation, confidence, sleep and energy) on a scale of 0-5 depending on their impact. The sum of scores for each item gives the subject's impact score ranging from 0 (no impact) to 40 (worst possible impact).

Secondary Outcome Measures
NameTimeMethod
change from baseline in Physical activity12 weeks

Physical activity will be assessed with the daily walking distance monitored by the application and wearable device.

subject satisfaction with health status12 weeks

changed from baseline in EQ-5D-5L

subject satisfaction with service12 weeks

Assessment tool: Patient's Global Assessment - Subjects are scored on four items (general, easy-to-follow, helpful in exercise and Physical fitness ) on a scale of 1-5 depending on their satisfaction level. The sum of scores for each item will be used for assessement of the subject's satisfaction in the trial.

change in Healthcare resource utilisation(the number of hospitalization) in COPD(chronic obstructive pulmonary disease) Patients12 weeks

Comparison with the number of hospitalization during the same period last year

change in Healthcare resource utilisation(hospitalization period) in COPD(chronic obstructive pulmonary disease) Patients12 weeks

Comparison with hospitalization period during the same period last year

change in Healthcare resource utilisation(the number of visiting emergency room) in COPD(chronic obstructive pulmonary disease) Patients12 weeks

Comparison with the number of visiting emergency room during the same period last year

Trial Locations

Locations (5)

Asan Medical Center

🇰🇷

Seoul, Korea, Republic of

Wonju Severance Christian Hospital

🇰🇷

Wonju, Gangwon-do, Korea, Republic of

Smg-Snu Boramae Medical Center

🇰🇷

Seoul, Korea, Republic of

KyungHee University Medical Center

🇰🇷

Seoul, Korea, Republic of

Hanyang University Guri Hospital

🇰🇷

Guri-si, Gyeonggi-do, Korea, Republic of

© Copyright 2025. All Rights Reserved by MedPath