Individualised monitoring programme for pulmonary rehabilitation of patients with chronic obstructive pulmonary disease-study protocol for a randomised controlled trial

Abstract

Background: Chronic obstructive pulmonary disease (COPD) is characterised mainly by exertional dyspnoea, which may lead to activity reduction. Pulmonary rehabilitation (PR) is considered capable of mitigating these impairments. However, access to PR is limited to specialised centres, especially during the coronavirus disease 2019 pandemic. Moreover, low-cost home rehabilitation programmes have non-individualised prescriptions, which might lead to inconsistent clinical effects in patients with COPD. Therefore, it is important to develop new, low-cost protocols involving individualised prescriptions and staff supervision.

Methods: This is a descriptive protocol for a randomised controlled study at the Grade III A Hospital in Tianjin. The sample size was calculated according to a described formula. Fifty-six participants will be selected and randomly allocated into two groups: (I) control (traditional PR training, medication, and nursing interventions); and (II) intervention [PR training in the hospital and at home by the Cardiopulmonary Rehabilitation System Management Platform (CSM)]. The protocol will be performed twice a week for 8 consecutive weeks in the outpatient clinic, and the training will be performed by the application of the CSM system in the final 6 months of the trial. The study will assess lung function and physical fitness and analyse the scores of the modified Medical Research Council Dyspnoea Scale, the COPD assessment test, the International Classification of Functioning, Disability, and Health, and the 6-minute walk test before and after the training protocol. Comparison of differences will be performed using repeated measures analysis of variance, a linear mixed effects analysis, or a non-parametric test, which will include only participants who completed all outcome measures and followed the intervention protocol. The study results will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals.

Discussion: The new, low-cost supervised rehabilitation programmes are expected to present positive results, making PR programmes more accessible and effective for patients with COPD.

Trial registration: The study was registered in the Chinese Clinical Trial Registry: ChiCTR2000040723.

Keywords: Chronic obstructive pulmonary disease (COPD); mobile health technology; pulmonary rehabilitation; randomised controlled trial.

Figure 1

A diagram of the proposed care pathway. CAT, COPD assessment test; mMRC, modified Medical Research Council Dyspnoea Scale; ICF, International Classification of Functioning, Disability, and Health; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; COPD, chronic obstructive pulmonary disease.

Figure 2

System architecture.

Figure 3

30-second chair stand. This image is published with the participants’ consent.

Figure 4

Arm curl. This image is published with the participants’ consent.

Figure 5

Back-scratch. This image is published with the participants’ consent.

Figure 6

Chair sit and reach. This image is published with the participants’ consent.

Figure 7

The one-legged stance test. This image is published with the participants’ consent.

Figure 8

Six-minute walking test. This image is published with the participants’ consent.