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Completed

NCT Number: NCT03432117

Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases

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

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Key information

Conditions

Respiratory Disease COPD Chronic Disease Disease Attributes Lung Cancer Lung Diseases Lung Diseases, Obstructive Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wonju Severance Christian Hospital, Wŏnju, Gangwon-do, South Korea

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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)

Primary outcomes

  1. change from baseline in Modified Medical Research Council dyspnea score

    Time frame: 12 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.

  2. change from baseline in COPD Assessment Test(CAT) score

    Time frame: 12 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).

  3. change from baseline in real distance walked for 6 minutes

    Time frame: 12 weeks

Secondary outcomes

  1. change from baseline in Physical activity

    Time frame: 12 weeks

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

  2. subject satisfaction with health status

    Time frame: 12 weeks

    changed from baseline in EQ-5D-5L

  3. subject satisfaction with service

    Time frame: 12 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.

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

    Comparison with hospitalization period during the same period last year

  6. change in Healthcare resource utilisation(the number of visiting emergency room) in COPD(chronic obstructive pulmonary disease) Patients

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Lifesemantics Corp.
  • Ministry of Trade, Industry and Energy

Registry information

Official study title

Multicenter Prospective Clinical Trial to Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Feb 14, 2018
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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