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Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases

Primary Purpose

Respiratory Disease, Lung Cancer, COPD

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fixed respiratory rehabilitation
Responsive respiratory rehabilitation
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Disease focused on measuring respiratory rehabilitation, personalized mobile services

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • Wonju Severance Christian Hospital
  • Hanyang University Guri Hospital
  • KyungHee University Medical Center
  • Asan Medical Center
  • Smg-Snu Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Fixed respiratory rehabilitation program(A)

Mixed respiratory rehabilitation program(B)

Control(C)

Arm Description

respiratory rehabilitation program for 12 weeks

Fixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks

Ordinary rehabilitation service of the site for 12 weeks

Outcomes

Primary Outcome Measures

change from baseline in Modified Medical Research Council dyspnea score
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) score
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).
change from baseline in real distance walked for 6 minutes

Secondary Outcome Measures

change from baseline in Physical activity
Physical activity will be assessed with the daily walking distance monitored by the application and wearable device.
subject satisfaction with health status
changed from baseline in EQ-5D-5L
subject satisfaction with service
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) Patients
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) Patients
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) Patients
Comparison with the number of visiting emergency room during the same period last year

Full Information

First Posted
January 22, 2018
Last Updated
February 27, 2018
Sponsor
Asan Medical Center
Collaborators
Ministry of Trade, Industry and Energy, Lifesemantics Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT03432117
Brief Title
Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases
Official Title
Multicenter Prospective Clinical Trial to Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
December 28, 2017 (Actual)
Study Completion Date
January 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Ministry of Trade, Industry and Energy, Lifesemantics Corp.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 how to do stretching, weight training with The-ra Band daily and weekly target of exercise alarm algorithms depending on patient's respiratory status(purse rate and O2 saturation)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disease, Lung Cancer, COPD
Keywords
respiratory rehabilitation, personalized mobile services

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The subjets were randomized(1:1:1) 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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fixed respiratory rehabilitation program(A)
Arm Type
Experimental
Arm Description
respiratory rehabilitation program for 12 weeks
Arm Title
Mixed respiratory rehabilitation program(B)
Arm Type
Experimental
Arm Description
Fixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks
Arm Title
Control(C)
Arm Type
No Intervention
Arm Description
Ordinary rehabilitation service of the site for 12 weeks
Intervention Type
Other
Intervention Name(s)
Fixed respiratory rehabilitation
Intervention Description
There are 6 step-exercise presented in the application and initial target of exercise will be set according to subject condition. After subject completes targeted exercise, next step will be started.
Intervention Type
Other
Intervention Name(s)
Responsive respiratory rehabilitation
Intervention Description
The application provide responsive exercise program by changing type and numbers of exercise according to subject condition and exercise ability (This will be assessed with monitored O2 saturation, symptom of dyspnea and pulse rate during exercise)
Primary Outcome Measure Information:
Title
change from baseline in Modified Medical Research Council dyspnea score
Description
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.
Time Frame
12 weeks
Title
change from baseline in COPD Assessment Test(CAT) score
Description
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).
Time Frame
12 weeks
Title
change from baseline in real distance walked for 6 minutes
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
change from baseline in Physical activity
Description
Physical activity will be assessed with the daily walking distance monitored by the application and wearable device.
Time Frame
12 weeks
Title
subject satisfaction with health status
Description
changed from baseline in EQ-5D-5L
Time Frame
12 weeks
Title
subject satisfaction with service
Description
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.
Time Frame
12 weeks
Title
change in Healthcare resource utilisation(the number of hospitalization) in COPD(chronic obstructive pulmonary disease) Patients
Description
Comparison with the number of hospitalization during the same period last year
Time Frame
12 weeks
Title
change in Healthcare resource utilisation(hospitalization period) in COPD(chronic obstructive pulmonary disease) Patients
Description
Comparison with hospitalization period during the same period last year
Time Frame
12 weeks
Title
change in Healthcare resource utilisation(the number of visiting emergency room) in COPD(chronic obstructive pulmonary disease) Patients
Description
Comparison with the number of visiting emergency room during the same period last year
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Facility Information:
Facility Name
Wonju Severance Christian Hospital
City
Wonju
State/Province
Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Hanyang University Guri Hospital
City
Guri-si
State/Province
Gyeonggi-do
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
KyungHee University Medical Center
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Smg-Snu Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33511633
Citation
Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
Results Reference
derived
PubMed Identifier
30143475
Citation
Kwon H, Lee S, Jung EJ, Kim S, Lee JK, Kim DK, Kim TH, Lee SH, Lee MK, Song S, Shin K. An mHealth Management Platform for Patients with Chronic Obstructive Pulmonary Disease (efil breath): Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Aug 24;6(8):e10502. doi: 10.2196/10502.
Results Reference
derived

Learn more about this trial

Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases

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