Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases

NCT03432117 | Completed

• 1 other identifier: C2016-00568
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Respiratory Disease; Lung Cancer; COPD

Keywords

respiratory rehabilitation; personalized mobile services

Outcome Measures

Primary Outcomes (3)

• 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.

  12 weeks

• 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).

  12 weeks

• change from baseline in real distance walked for 6 minutes

  12 weeks

Secondary Outcomes (6)

• change from baseline in Physical activity

  12 weeks

• subject satisfaction with health status

  12 weeks

• subject satisfaction with service

  12 weeks

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

  12 weeks

• change in Healthcare resource utilisation(hospitalization period) in COPD(chronic obstructive pulmonary disease) Patients

  12 weeks

Study Arms (3)

Fixed respiratory rehabilitation program(A)

EXPERIMENTAL

respiratory rehabilitation program for 12 weeks

Other: Fixed respiratory rehabilitation

Mixed respiratory rehabilitation program(B)

EXPERIMENTAL

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

Other: Fixed respiratory rehabilitation; Other: Responsive respiratory rehabilitation

Control(C)

NO INTERVENTION

Ordinary rehabilitation service of the site for 12 weeks

Interventions

Fixed respiratory rehabilitation OTHER

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.

Fixed respiratory rehabilitation program(A); Mixed respiratory rehabilitation program(B)

Responsive respiratory rehabilitation OTHER

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)

Mixed respiratory rehabilitation program(B)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Ministry of Trade, Industry and Energy: collaborator
• Lifesemantics Corp.: collaborator

Study Sites (5)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, 11923, South Korea

Location

KyungHee University Medical Center

Seoul, 02447, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Smg-Snu Boramae Medical Center

Seoul, 07061, South Korea

Location

Related Publications (2)

• 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.

  PMID: 33511633 DERIVED

• 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.

  PMID: 30143475 DERIVED

MeSH Terms

Conditions

Respiration Disorders; Lung Neoplasms; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: 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).

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: February 14, 2018
• Study Start: May 15, 2017
• Primary Completion: December 28, 2017
• Study Completion: January 6, 2018
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

KR (5)