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Telerehabilitation program for COVID-19 survivors (TERECO) - Randomized controlled trial

Citation

Reinhardt, Jan D. (2021), Telerehabilitation program for COVID-19 survivors (TERECO) - Randomized controlled trial, Dryad, Dataset, https://doi.org/10.5061/dryad.59zw3r27n

Abstract

Objectives

To investigate superiority of a telerehabilitation program for Covid-19 (TERECO) over no rehabilitation with regard to exercise capacity, lower-limb muscle strength (LMS), pulmonary function, health-related quality of life (HRQOL), and dyspnoea.

Design

Parallel-group randomised controlled-trial with 1:1 block-randomisation.

Setting

Three major hospitals from Jiangsu and Hubei provinces, China.

Participants

120 formerly hospitalised Covid-19 survivors with remaining dyspnoea complaints were randomised with 61 allocated to control and 59 to TERECO.

Intervention

Unsupervised home-based 6-week exercise program comprising breathing control and thoracic expansion, aerobic exercise, and LMS exercise, delivered via smartphone, and remotely monitored with heart rate telemetry.

Outcomes

Primary outcome was 6-minute walking distance (6MWD) in metres. Secondary outcomes were squat time in seconds; pulmonary function assessed by spirometry; HRQOL measured with SF-12; and mMRC-dyspnoea. Outcomes were assessed at 6 weeks (post-treatment) and 28 weeks (follow-up).

Results

Adjusted between-group difference in change in 6MWD was 65.45 metres (95% CI 43.8, 87.1; p<0.001) at post-treatment and 68.62 metres (95% CI 46.39, 90.85; p<0.001) at follow-up. Treatment effects for LMS were 20.12 seconds (95% CI 12.34, 27.9; p<0.001) post-treatment and 22.23 seconds (95% CI 14.24, 30.21; p<0.001) at follow-up. No group differences were found for lung function except post-treatment MVV. Increase in SF-12 physical component was greater in the TERECO group with treatment effects estimated as 3.79 (95% CI 1.24, 6.35; p=0.004) at post-treatment and 2.69 (95% CI 0.06, 5.32; p=0.045) at follow-up.

Conclusions

This trial demonstrated superiority of TERECO over no rehabilitation for 6MWD, LMS, and physical HRQOL.

Trial registration: ChiCTR2000031834, URL: http://www.chictr.org.cn/showproj.aspx?proj=52216

Methods

Data are from a multi-centre, parallel-group randomised controlled trial. The original protocol for this study is available from (URL: http://idmr.scu.edu.cn/info.htm?id=1841614474692833). This study was registered at the Chinese Clinical Trial Registry on 11 Apr 2020 (ChiCTR2000031834). Ethical approval was first received from the Institutional Review Board (IRB) of the First Affiliated Hospital of Nanjing Medical University/Jiangsu Province Hospital (2020-SR-171, 9 April 2020) and then subsequently from the IRBs of Hubei Province Hospital of Integrated Chinese and Western Medicine (2020016, 14 April 2020), and Huangshi Hospital of Chinese Medicine (HSZYPJ-2020-026-01, 20 April 2020).

Three centres from Jiangsu (The First Affiliated Hospital of Nanjing Medical University), Hubei Wuhan (Hubei Province Hospital of Integrated Chinese and Western Medicine), and Hubei Huangshi (Hubei Huangshi Hospital of Chinese Medicine) collected data from 119 patients recovering from COVID-19 after discharge from one of the centres (60 assigned to control and 59 assigned to intervention). Data were collected between 26 April and 9 December 2020 at three time points: baseline, post-treatment assessment at 6 weeks and follow-up assessment at 28 weeks.

Assessed outcomes included 6 minute walking distance, squat time in seconds, pulmonary function parameters (FEV1, FVC, FEV1/FVC, PEF, MVV), SF-12 medical outcomes short form, mMRC dyspnea (favorable outcome: being dyspnea-free). Adverse events were also recorded.

Usage Notes

Two types of data sets are provided: outcome and descriptive patient data in wide format and adverse event data in long format. Data sets can be linked with an annymized patient ID. Both datasets are provided as Stata 14 files (labled) and csv files (unlabled). Each dataset has a corresponding codebook.

Funding

Department of Science and Technology of Sichuan Province, Award: 21ZDYF1918

Central Universities in China, Award: 20827041D4161

Xi'an Science and Technology Bureau, Award: XA2020-HWYZ-0043

Jiangsu CF PharmTech, Inc.