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Completed

NCT Number: NCT03754881

Efficacy of 8-week Supervision in Home Based Pulmonary Rehabilitation

In korea, it is not easy to practice standard pulmonary rehabilitation (PR). in this study, we'll educate PR to patients and make reservation for re-visiting outpatients clinics with PR diary. we want to confirm whether patients, who perform home based PR during more than 30 minutes in 3 days per week, present improved dyspnea score or quality of life compared with non-compliance group.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine

Seoul, 138-736, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • forced expiratory volume-one second / forced vital capacity < 0.7 in post-bronchodilator pulmonary function test
  • adults 40 years or older
  • no history of acute exacerbation within 4 weeks
  • no history of education for pulmonary rehabilitation within 6 months
  • no change of medication for chronic obstructive pulmonary disease within 4 weeks
  • dyspnea more than Modified Medical Research Council grade 0

Exclusion criteria

  • adults under 40 years old
  • no consent
  • history of acute exacerbation within 4 weeks
  • history of education for pulmonary rehabilitation within 6 months
  • change of medication for chronic obstructive pulmonary disease within 4 weeks
  • dyspnea only Modified Medical Research Council grade 0
  • comorbidity, including cardiovascular disease, orthopedic disease, neurologic disease, optic disease, uncontrolled hypertension
  • enrolled other clinical trial
  • on long term oxygen therapy

Treatment and study plan

Pulmonary rehabilitation

Behavioral

In this study, we'll educate pulmonary rehabilitation to patients and make reservation for re-visiting outpatients clinics with PR diary after 8 weeks.

we want to confirm whether patients, who perform home based PR during more than 30 minutes in 3 days per week, present improved dyspnea score or quality of life compared with non-compliance group.

Primary outcomes

  1. Change from basline Chronic obstructive pulmonary disease (COPD) assessment Test (CAT) at 8 weeks

    Time frame: 8 weeks

    Self reported Patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dyspnea, chest tightness) on health status. Each item is scored 0-5, yielding a total between 0 and 40

Secondary outcomes

  1. change from 6 minutes walk test at 8 weeks

    Time frame: 8 weeks

    This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD).

  2. Change from the Short Form 36 Health survey (SF-36), version 2.0 at 8 weeks

    Time frame: 8 weeks

    a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.

  3. Change from BODE index at 8 weeks

    Time frame: 8 weeks

    BODE index include forced expiratory volume-one second, 6 minutes walk distance, modified Medical Research Council dyspnea scale, body mass index. The BODE Index is used to predict mortality.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 27, 2018
Registry last updated
Jun 1, 2022

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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