Smartphone application-based rehabilitation in patients with chronic respiratory and cardiovascular diseases: a randomised controlled trial study protocol

BMJ Open. 2023 Sep 20;13(9):e072698. doi: 10.1136/bmjopen-2023-072698.

Abstract

Introduction: Rehabilitation is well known to improve clinical symptoms and decrease the risk of mortality in patients with chronic respiratory or cardiovascular diseases. We will evaluate the efficacy of smartphone application-based rehabilitation programmes in patients with chronic respiratory or cardiovascular diseases.

Methods and analysis: This single-centre single-blind randomised controlled trial will recruit a total of 162 participants from Asan Medical Center (81 patients each for pulmonary and cardiac rehabilitation, respectively). Participants will be assigned to the pulmonary or cardiac rehabilitation groups based on their underlying disease. Participants will be allocated randomly into the intervention or control groups at the ratio of 2:1 (54 and 27 patients). The intervention group will be provided with a smartphone application and undergo smartphone application-based rehabilitation for 12 weeks. The control group will receive the usual outpatient medical treatment without rehabilitation. Participants will be evaluated at baseline and at the end of the rehabilitation. The primary outcomes will be exercise capacity, such as maximal oxygen consumption on cardiopulmonary exercise test for both groups, chronic obstructive pulmonary disease assessment test for the pulmonary rehabilitation group, and Health-related Quality of Life Instrument with 8 Items questionnaires for the cardiac rehabilitation group. The secondary outcomes will include quality of life questionnaires, symptom scores, pulmonary function test and limb muscle test.

Ethics and dissemination: The study protocol was approved by the Institutional Review Board of Asan Medical Center. Written informed consent will be obtained from all participants prior to inclusion. The findings from this study will be disseminated through peer-reviewed scientific journals and conferences.

Trial registration number: NCT05610358.

Keywords: cardiology; rehabilitation medicine; respiratory medicine (see thoracic medicine).

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cardiovascular Diseases*
  • Humans
  • Outpatients
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Single-Blind Method
  • Smartphone

Associated data

  • ClinicalTrials.gov/NCT05610358