Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases

Asan Medical Center

Status: Completed

Conditions: Respiratory Disease; Lung Cancer; COPD

Treatments: Other: Responsive respiratory rehabilitation; Other: Fixed respiratory rehabilitation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03432117

C2016-00568

Details and patient eligibility

About

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

Full 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)

Enrollment: 179 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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179 participants in 3 patient groups

Fixed respiratory rehabilitation program(A)

Experimental group

Description:

respiratory rehabilitation program for 12 weeks

Treatment:

Other: Fixed respiratory rehabilitation

Mixed respiratory rehabilitation program(B)

Experimental group

Description:

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

Treatment:

Other: Fixed respiratory rehabilitation

Other: Responsive respiratory rehabilitation

Control(C)

No Intervention group

Description:

Ordinary rehabilitation service of the site for 12 weeks