Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases

A

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)

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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