Effectiveness of a telerehabilitation program for COVID-19 survivors (TERECO) on exercise capacity, pulmonary function, lower limb muscle strength, and quality of life: a randomized controlled trial

  1. Jian’an Li
  2. Wenguang Xia
  3. Chao Zhan
  4. Shouguo Liu
  5. Zhifei Yin
  6. Jiayue Wang
  7. Yufei Chong
  8. Chanjuan Zheng
  9. Xiaoming Fang
  10. Wei Cheng
  11. Jan D. Reinhardt

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Abstract

Objectives

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

Design

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

Setting

Three major hospitals from Jiangsu and Hubei provinces, China.

Participants

120 Covid-19 survivors with modified Medical Research Council (mMRC) dyspnoea score of 2-3 who had been discharged from hospital were randomised. 61 were allocated to the control group and 59 to the TERECO group.

Intervention

The control group received educational instructions. The TERECO group participated in a 6-week home-based, pulmonary rehabilitation program delivered via smartphone and monitored with chest-worn heart rate telemetry. Exercise types comprised breathing control and thoracic expansion, aerobic exercise, and LMS exercise.

Outcomes

Primary outcome was 6-minute walking distance (6MWD) in metres. Secondary outcomes were LMS measured as squat time in seconds; pulmonary function assessed by spirometry with parameters being forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC, maximum voluntary ventilation (MVV), and peak expiratory flow; HRQOL measured with SF-12 physical component score (PCS) and mental component score (MCS); and mMRC dyspnoea, favourable outcome (no dyspnoea). Outcomes were assessed at 6 weeks (post-treatment) and 28 weeks (follow-up).

Results

120 patients were randomised, 15 (12.5%) were lost to follow-up at study endpoint. No serious adverse events occurred. 38 participants in the TERECO group complied with the exercise protocol (64.41% of randomized). The adjusted between-group difference in change in 6MWD from baseline 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 apart from post-treatment MVV (10.57 litres/minute, 95% CI 0.26-17.88, p=0.005). Increase in SF-12 PCS 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. No significant between-group differences were found for improvements in SF-12 MCS. At post-treatment 90.4% endorsed a favourable outcome for mMRC dyspnoea in the TERECO group vs. 61.7% in control (adjusted RR 1.46, 1.17-1.82, p=0.001).

Conclusions

This trial demonstrated superiority of TERECO over no rehabilitation for 6MWD, LMS, and SF-12 PCS. We found no persistent effects on pulmonary function, SF-12 MCS, and perceived dyspnoea.

Trial registration

Chinese Clinical Trial Registry: ChiCTR2000031834, 11 Apr 2020, URL: http://www.chictr.org.cn/showproj.aspx?proj=52216

KEY POINTS

What is already known

Many Covid-19 survivors discharged from hospital have reduced exercise capacity, impaired pulmonary function, muscle weakness, and reduced quality of life, all of which might be addressed with pulmonary rehabilitation.

However, evidence on effective pulmonary rehabilitation measures for this population is currently lacking. As delivery of conventional rehabilitation services is furthermore limited due to pandemic control measures, telerehabilitation programs represent a possible alternative.

What the study adds

We developed a telerehabilitation program for Covid-19 survivors (TERECO program) that is delivered via smartphone and can be carried out at home.

Our study suggests that TERECO was safe and participants of the TERECO program had improved exercise capacity, lower-limb muscle strength, and physical quality of life. No relevant group differences were found for lung function, self-reported breathlessness, and mental quality of life.

The TERECO program is inexpensive and could be implemented on a large scale to improve physical health of Covid-19 survivors after discharge from hospital.

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    SciScore for 10.1101/2021.03.08.21253007: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: 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).
    Consent: If the candidates expressed interest, an appointment for a baseline visit was made and informed written consent was obtained from all study participants at this baseline visit.
    Randomizationnot detected.
    BlindingBlinding: Participants and therapists could not be blinded.
    Power AnalysisTo achieve 80% power with an alpha error of 5%, a minimal sample size of 96 participants (48 per group) was needed to detect a statistically significant signal for a between-group difference in change in 6MWD (with SD 99 in control and SD 71 in the intervention group as reported by Lau for a trial in a SARS population11).
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical analysis: All analyses were performed with STATA 14.0.
    STATA
    suggested: (Stata, RRID:SCR_012763)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Limitations of this research include participant characteristics: only Covid-19 survivors with moderate dyspnoea symptoms who had previously been hospitalized for treatment were included. The results are thus not generalizable to persons with no, mild or severe dyspnoea, nor to people who contracted SARS CoV-2 but were not hospitalised for it. Another important weakness is the unexpected change of the location and resulting delay of the final follow-up assessment because regulations pertinent to the protection of health professionals from infection no longer permitted assessment visits. While conditions remained the same between intervention and control group, it is unclear how this may have affected patient-reported assessments and pulmonary function testing. Low-certainty evidence (one randomised crossover trial) suggests that 6MWT performed outdoors yields comparable results to centre-based testing.40 Emerging evidence suggest that most profound impairment of lung function in Covid-19 occurs in diffusion capacity2,41 usually measured as the diffusion capacity of the lung for carbon monoxide (CO) or the transfer capacity for CO. This was unclear at the time of study design and the required measurement procedures are difficult to perform in the home setting. Comparability of the occurrence of adverse events across groups during the intervention period was also limited by additional prompts in the intervention group issued in weekly consultations with therapists and through R...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  2. Version published to 10.1101/2021.03.08.21253007v1 on medRxiv