key: cord-1052764-epoemg5x authors: Barman, Apurba; Sinha, Mithilesh K; Sahoo, Jagannatha; Jena, Debasish; Patel, Vikas title: Respiratory Rehabilitation in Patients Recovering from Severe Acute Respiratory Syndrome: A Systematic Review and Meta-analysis date: 2022-01-14 journal: Heart Lung DOI: 10.1016/j.hrtlng.2022.01.005 sha: f41a311955e491babae090acb6e143d56ed70582 doc_id: 1052764 cord_uid: epoemg5x BACKGROUND: With an increase in published reports on respiratory rehabilitation (RR) programs in severe acute respiratory syndrome (SARS), there is a need for a meta-analysis and systematic review to measure the effects of RR program in SARS. OBJECTIVE: Objective of the review was to evaluate the efficacy and safety of RR program in patients recovering from SARS. METHODS: PubMed/ MEDLINE, CENTRAL, EMBASE, and Clinical Trial Registries were systematically searched (between January 1, 2003, to July 31, 2021) to identify all patients who received RR program, at least for six days, following SARS. The primary outcome was exercise capacity [6-meter walking distance (6-MWD)], and secondary outcomes were change in pulmonary function test (PFT) parameters, activities in daily livings (ADLs), and quality of life (QoL). Meta-analysis was performed by using RevMan 5.4. RESULTS: Twenty-one observational studies, including eight comparative studies, were included. Eight comparative studies participated in quantitative meta-analysis. The intervention group, who received RR program, improved significantly in exercise capacity (6-MWD) [mean difference (MD):45.79, (95% CI:31.66-59.92)] and PFT parameters, especially in forced vital capacity (FVC%) [MD:4.38, (95% CI:0.15-8.60)], and diffusion lung capacity for carbon monoxide (DLCO%) [MD:11.78, (95% CI:5.10-18.46)]. The intervention group failed to demonstrate significant improvement in ADLs and QoL outcomes. No significant adverse events were reported during the intervention. CONCLUSION: Respiratory rehabilitation can improve exercise capacity and PFT parameters in patients recovering from SARS infection. RR program does not cause serious adverse events. There is a need for clinical trials to measure the long-term efficacy of the RR program. Severe acute respiratory syndrome (SARS) is a serious health concern, a rapidly progressive respiratory syndrome, which is caused by severe acute respiratory syndrome coronavirus-1 (SARS-CoV-1) and coronavirus-2 (SARS-CoV-2). SARS-CoV was identified as a global threat in 2003 (SARS-CoV-1) and 2019 (SARS-CoV-2). 1, 2 The lung injury in SARS is caused either due to direct viral effects or immune pathogenic factors. 1 Approximately 20 to 30% of patients with SARS may require intensive care unit (ICU) treatment, including mechanical ventilation. 2 The lung damage in SARS-CoV is mainly characterized by diffuse alveolar damage, which ultimately can lead to either pleural effusion, pulmonary edema, and or consolidation/ fibrosis of the lung. 1 It is already evident from the literature that respiratory rehabilitation (RR) may improve dyspnoea, functional capacity, and health-related quality of life (QoL). Despite this widespread clinical acceptance and demonstration of the therapeutic potential of the RR in chronic obstructive lung diseases, there is uncertainty about the precise therapeutic efficacy of the RR in patients recovering from SARS CoV infection. Recently many reviews, consensus reports, guidelines, expert opinions have been published on recommending RR in patients recovering from SARS-CoV infection. [3] [4] [5] [6] [7] [8] [9] [10] However, most of these reviews are based on previous experience managing other chronic lung diseases, not on patients" research data on SARS infection. Therefore, it is essential to accumulate data for RR programs' evidence, clarify the benefit, and strengthen its rationale for incorporating standard clinical management in patients with SARS-CoV infection. In this review, we summarised all the available literature and determined the efficacy and safety of the RR program following SARS infection. The review was performed according to the PRISMA-P 2015 (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. 11, 12 The study protocol was registered prospectively in the International Prospective Register of Ongoing Systematic Reviews (Systematic review registration -PROSPERO 2021: ****). Observational studies of any kind [randomized controlled trials (RCT), nonrandomized clinical trials (non-RCT), studies with cohort design (prospective or retrospective), or case series (with minimum of 5 participants)], published as an article or as a pre-print, were eligible for inclusion. Duplicate studies, case series with less than 5 participants, case reports, meta-analyses, review articles, consensus documents, comments, opinion articles, and letters not presenting the original data were excluded from this review. Articles written in languages other than English were excluded. Patients, with any age, with (1) SARS either due to SARS-CoV-1 or SARS-CoV-2 infection, (2) who underwent the RR program for at least six days, (3) who were admitted and treated in an inpatient hospital (irrespective of severity) for the acute management of SARS, were included in this review. The RR program consisting of "aerobic exercises (endurance training)' and/or "respiratory muscle training (RMT) exercises" was considered the primary treatment for SARS-CoV infection. The RR program, which was administered only after the diagnosis of SARS, was included in this review. No restriction was placed based on rehabilitation technique (components of RMT or aerobic /endurance training), exercise frequency/ schedule, exercise duration, and rehabilitation set-up (ICU/ inpatient /outpatient/ home). Research articles, with or without having any control group (only intervention group), were included in this review. For the quantitative meta-analysis, it was mandatory to have a control/ comparison group. Control groups involved 'any interventions other than RR program (an education program/ video program)' or 'no intervention' along with standard medical care for SARS. For descriptive/narrative analysis, it was not mandatory to have a comparison group. Exercise capacity (endurance), measured by "six-minute walk distance (6-MWD) in meters', was used to assess the primary outcome. Secondary Outcomes were (1) The FIM instrument comprises of 18 items; 13-items [self-care (6-items), sphincter control (2-items), transfer (3-items), locomotion (2-items)] to assess motor-ADL (subscale) and 5items [communication (2-items) , social cognition (3-items)] to measure cognitive-ADL (subscale). [13] [14] [15] The short-form health survey (SF-12), one of the most widely used tools 16 , measures healthrelated QoL. The SF-12 is a reduced version of the SF-36 scale, and it covers the same 8health dimensions as the SF-36 but with substantially fewer questions (12-questionnaire). [16] [17] [18] EuroQuality-5Dimensions-3Levels (Eq-5D-3L) (0-100 points; 0: worst and 100: best healthrelated QoL) is a valid tool to measure QoL domains involving mobility, self-care, usual care, pain/discomfort, and anxiety/ depression. 19, 20 St. George"s Respiratory Questions (SGRQ) is used to measure health impairments (HRQoL) in airway diseases. It has three componentsdyspnoea, activity, and impacts (on daily life). The total score (0-100) indicates overall health and perceived wellbeing. The higher the SGRQ score, the more limitations are. 21, 22 Search strategy A comprehensive systematic literature search was performed in MEDLINE/ PubMed, CENTRAL, EMBASE, Clinical Trial Registries, medRxiv, and Research Square to find the published and unpublished research articles (clinical trials and observational studies) on the RR program following SARS-CoV infections (SARS-CoV-1 and SARS-CoV-2). The search strategy was developed from January 1, 2003, to July 31, 2021. The reference lists of published articles were also searched manually. The relevant keywords and MeSH terms, which were used during the literature search, were "severe acute respiratory syndrome" OR "SARS" OR "SARS-CoV" OR "SARS-CoV-1" OR "SARS-CoV-2" OR "Coronavirus" OR "coronavirus" OR "COVID" OR "COVID-19" AND "rehabilitation" OR "respiratory rehabilitation" OR "respiratory muscle training" OR "Respiratory therapy" OR "pulmonary rehabilitation" OR "physiotherapy" OR "physical therapy" OR "physical intervention" OR "exercise" OR "exercises." According to the inclusion and exclusion criteria, two reviewers (**and **) independently searched the articles and identified them as included, excluded, or uncertain. The full-text article was obtained and reviewed for eligibility based on the inclusion criteria in case of uncertainty. Two reviewers (** and ***) extracted the data independently with a standardized data collection form, including (1) author, year, setting (country, ICU, In-patient (IPD), Outpatient (OPD), home) (2) participants (number, mean age and gender, type of viral infections, and severity of the disease, (3) inclusion and exclusion criteria, (4) intervention (components of RR program, frequency, intensity, and duration), (5) results (outcome measures, effect, significance) (6) safety (adverse events, mortality due to intervention). Any discrepancies during the selection and data collection were resolved by discussion and consensus. For studies with more than one-time point to observe and assess, the outcome data assessed at the end of intervention (RR program) was included. For continuous outcomes, mean values, standard deviation (SD), and total participants were extracted. For dichotomous outcomes, the total number of events and total participants were extracted. If mean and SD were not reported in the particular study, it was calculated manually from the reported indicators. If data were not available or written in an unusable way, the specific research was excluded from meta-analysis, and the data were presented descriptively. Only comparative ('RR program" versus "No RR program") studies [clinical trials and comparative observational studies] were included in the meta-analysis. Meta-analysis was performed by Review Manager software (Rev-Man 5.4) (The Cochrane Collaboration, Copenhagen, Denmark). As per the recommendation of the Cochrane handbook, during analysis, the random-effects model analysis was utilized, as there could be heterogeneity (none of the studies applied the same set of RR programs) among the original studies, which might not be evident in the data. The methodological quality of the comparative studies was assessed with the Newcastle -Ottawa scale (NOS) 23 , which is being used to measure the risk of bias of observational (nonrandomized) studies. A score >7 on NOS was considered a high-quality study. The higher the total NOS, the lower the risk of bias was. 23 Two reviewers (** and **) independently extracted data and performed the risk-of-bias assessment. Disagreements between these two reviewers were resolved by discussion with a third reviewer (**). The outcome measures of interest, exercise capacity/ endurance (6-MWD), change in PFT parameters, ADL and QoL scores were presented as continuous data, and mortality events (deaths during study period) were presented as categorical data. For quantitative meta-analysis of comparative studies (to measure the treatment effect), either "the mean differences (MD)" or "the standardized mean difference (SMD)" with corresponding 95% confidence intervals (CIs) was used to calculate the effect sizes of continuous outcomes measures. The significance level was fixed at P< .05. Data from non-comparative observational studies or case series were presented and discussed narratively. In non-comparative studies, the therapeutic efficacy of the RR program (change in outcome) was considered significant if there was a significant change (p<0.05) following the RR program. The overall efficacy of the RR program was assessed according to the criteria recommended by the French Haute Autorité de la santé 24 , which is being used to evaluate the level of scientific proof. The levels of evidence were categorized into four classes, ranging from level-1 (well-powered, randomized, comparative trials) to level-4 (comparative studies with marked biases and retrospective studies). 24 A total of 4211 articles were retrieved from January 1, 2003, to July 31, 2021. After excluding the irrelevant (not matching the inclusion and exclusion criteria) and duplicate reports, 21-articles were included in this review (Fig 1) . Out of 21-articles , eight [25] [26] [27] [28] [29] [30] [31] [32] were comparative ("RR program" versus "No RR program") studies, and thirteen [33] [34] [35] [36] [37] [38] [39] [40] [41] [42] [43] [44] [45] were non-comparative (only intervention (RR program) group) studies. Among comparative studies, five [25] [26] [27] [28] [29] were clinical trials, three [30] [31] [32] were cohort studies (two-studies 30,32 with prospective-cohort, and one 31 with retrospective-cohort design). Only comparative studies (8-articles) [25] [26] [27] [28] [29] [30] [31] [32] were included for the quantitative meta-analysis. However, all observational studies (21-articles) were included for descriptive and qualitative analysis. Characteristics of all included studies where the RR program was undertaken have been presented in Table 1 . Irrespective of the study design, 996 patients (21-articles) received the RR program. The mean age of the patients, who received the respiratory rehabilitation following SARS, ranged from 37.1 to 70.5 years. The RR program was conducted in an in-patient (IP) setting (12-studies) 28, 29, 33, 36, [38] [39] [40] [41] [42] [43] [44] [45] , in ICU setting (3-studies) 31, 32, 34 , in OPD (3-studies) 26, 27, 37 , and in home (3-studies) 25, 30, 35 settings. The duration of the RR program ranged from 1-week to 6-weeks. Each study used a different protocol for the RR (exercise schedule). Components of the RR program used in each study have been presented in Table 1 . The intensity, duration, and frequency of exercises (in the RR program) were individualized, according to each patient"s physical capacity and medical stability. Among the various RR techniques, respiratory muscle training (RMT) was included in 16-studies 25, 26, [28] [29] [30] [31] 33, 34, 36, [38] [39] [40] [41] [42] [43] 45 , aerobic exercises/ endurance training in 19-studies [25] [26] [27] [28] [30] [31] [32] [33] [34] [35] [36] [37] [38] [39] [41] [42] [43] [44] [45] and strength/resistance training in 12-studies 25, 27, 30, 33, [36] [37] [38] [39] [41] [42] [43] 45 . Besides these techniques (RMT, aerobic/ endurance training, and strength/resistance training), relaxation, occupational therapy, energy conservation techniques, and psychological support were incorporated in a few research articles as part of the RR program. In the quantitative meta-analysis, only eight comparative studies (334 participants received respiratory rehabilitation (RR), and 319 received "No RR program") were included. The mean age of patients, who were included in the meta-analysis, were ranged from 37.1 years to 70.4 years. One-hundred thirty-three patients reported SARS secondary to SARS-CoV-1, and 461 reported SARS secondary to SARS-CoV-2. The quality assessments (the risk of bias) of individual articles (included in the metaanalysis) have been presented in [ Table 2 ]. Exercise capacity (endurance) was reported in five-comparative studies [25] [26] [27] [28] 31 . Pooled analysis from these 5-comparative studies [25] [26] [27] [28] 31 (222 received "RR program", 213received "No RR program"), reported mean difference (MD) of 6-MWD: 45.79 meters (95% CI: 31.66 to 59.92 meter, I 2 = 38%). (Fig 2) After excluding the retrospective study (Qi Di) 31 , the mean difference in 6-MWD reached 53.07 meters (95% CI: 39.23.7 to 66.9 meter), and heterogeneity was reduced to 0%. Thus, irrespective of inclusion or exclusion of the study by Qi Di et al. 31 , the mean difference in 6-MWD between two groups (active intervention versus control) remained significantly in favor of the RR group. The PFT parameters were reported in 4-articles 25, 26, 29, 31 . Researchers expressed the PFTparameter data in (% pred) and (absolute volume) values to examine the effect on PFT parameters. In 2-articles 29,31 , the PFT parameters were expressed in (% pred) value, and in another two-articles 25, 26 , PFT parameters were presented in absolute volume (liter). They (% pred and liter) were analyzed separately. The pooled data from the two-studies 29 To explore whether the RR program had an effect on ADL, the FIM scores were included. The FIM scores were reported in 2-articles 26, 31 . The pooled data from this 2-studies 26, 31 demonstrated that the MD of FIM scored 3.68 points (95% CI: -2.93 to 10.30), I 2 = 67%] (Fig S3) . The Health-related QoL was assessed in 6-articles [25] [26] [27] 29, 31, 32 . In four articles (164 received "RR program", 159 received "No RR program") [25] [26] [27] 32 , the QoL was assessed with a short form-general health survey (either with SF-36 or SF-12) questionnaires. In one article, it (QoL) was assessed with "EuroQuality-5Dimensions-3Levels" questionnaires 29 and in another article with "St. George Respiratory Questions" questionnaires 31 . The short form-general health survey questionnaires (SF-36 and SF-12) QoL scale does not have a single total QoL score. 18 Therefore, the short-form general health survey questionnaires [SF-36 and SF-12] were assessed separately. Pooled data from the four-studies [25] [26] [27] 32 , where SF health questionnaires (SF-12/ SF-36) was used to measure QoL, showed the SMD of 0.79 points (95% CI: -0.17 to 1.75), I 2 = 93%] in physical health (Fig S4) , and SMD of 0.47 point (95% CI: -0.24 to 1.19), I2= 88%] (Fig S5) in mental health. The pooled data from the other 2-studies 29, 31 , where QoL was expressed in total overall QoL score, ["EuroQuality-5Dimensions-3Levels" and "St. George Respiratory Questions" questionnaires] showed the SMD of 1.35 points (95% CI: -0.08 to 2.79), I 2 = 90%] between active intervention and control group (Fig S6) . Thus, irrespective of QoL outcome scales, the SMD between the two ("RR program" versus "No RR program") groups remained non-significant (though there was a tendency of improvement in favor of the RR group) None of the studies reported any significant adverse events (falls, arrhythmia, severe hypertension, hypotension, syncope, ischaemic heart disease, cardiac arrest, and death) during or after the RR program. No dropouts were reported due to intolerance or adverse events of the RR program. No deaths were reported due to active intervention (RR program). However, deaths were reported due to other causes (disease itself and comorbidities) from 3-studies 28, 31, 32 . Irrespective of causes, there was no significant difference in deaths in both groups ("RR program" versus "No RR program") [relative risk: 0.73, (95% CI: 0.19 to 2.86), I 2 =39%] (Fig S7) , which indicated that intervention (RR program) did not significantly increase or decrease the mortality rates among survivors. The clinical outcomes of non-comparative studies (change in outcome parameters following the RR program) have been presented in Table 3 . However, irrespective of study designs, all studies (21-studies) were included to summarize the overall efficacy of the RR program. The summary of the overall effectiveness, according to criteria recommended by the French Haute Autorité de la santé 24 of the RR program, has been presented in Table 4 . Out of 21-articles, 13-articles (9 non-comparative studies) assessed 6-MWD. Twelve articles [except one article (with level-2 evidence)] showed significant improvement (p <0.05) in 6-MWD following the RR program. Among the 12-articles, three articles were RCTs (Level-1 evidence) [25] [26] [27] , which demonstrated the considerable change (p<0.05) in 6-MWD compared to the control intervention. Seven-articles 25, 26, 29, 31, 33, 36, 39 reported the PFT parameters (FVC, FEV1, DLCO) before and after the RR-program. Five research articles demonstrated a significant change in FVC and FEV1 parameters following the RR program. Three research articles 26, 31, 33 assessed the diffusing capacity of the lung (DLCO) following RR intervention. All articles 26, 31, 33 showed considerable improvement (p<0.05) in DLCO following the RR program. This study gives an idea of the efficacy of aerobic exercises/ aerobic training and RMT exercises among patients with SARS recovering from active disease. This is the first review article on a meta-analysis on SARS and respiratory rehabilitation (RR) program. The present meta-analysis suggested a beneficial effect of the RR program following SARS infection, especially in terms of improvement in exercise capacity (6-MWD) and pulmonary function parameters (FVC%, FEV1(liter) and DLCO%). It is already evident that severe acute respiratory syndrome, caused by SARS CoV-1 and SARS-CoV-2, causes significant lung damage (acute lung injury), along with the involvement of other organs. 34 Acute lung injury, multi-organ involvement, prolonged bed rest, ICU care, adverse drug effects, and residual disease pathology can cause respiratory distress, dyspnoea, and palpitation during walking and daily functional activities. Respiratory distress during walking/ activities can cause significant impairment in exercise capacity (endurance) and PFT parameters. 34 Exercise intolerance, measured by exercise capacity, is one of the key features of acute and chronic lung diseases 9 and is associated with poor survival 46 and reduced QoL 47 . Self-paced 6-MWD is a validated tool to measure the exercise capacity following pulmonary diseases 9,46 , and it correlates with peak functional or aerobic capacity 34, 48 . Chan KS et al. 48 Previous Cochrane and non-Cochrane reviews demonstrated the positive effects of pulmonary rehabilitation programs on increasing exercise capacity and PFT parameters in chronic lung disease [49] [50] [51] [52] [53] [54] [55] , including chronic obstructive pulmonary disease and interstitial lung diseases. The American Thoracic Society/European Respiratory Society defined pulmonary rehabilitation as a patient-tailored, structured, comprehensive intervention that included patient assessment, exercise training, education, and behavior training as essential for pulmonary rehabilitation. 9 Pulmonary rehabilitation is usually being delivered over several weeks. During this review, we observed that many pulmonary rehabilitation program components, like education and behavioral treatment, were not instructed in many patients. In a few studies, the study duration was very short (1-week), and there was a lack of consistent, thorough assessment at baseline and follow-up visits. There were significant variations in the exercise or activity schedules, though the core components 9 of the pulmonary rehabilitation program-aerobic exercise/ endurance training and RMT exercises were included in all studies. Any form of exercise (walking exercise, running, cycling, ergometer training, etc.) or physical activity (mobility training, treadmill training, etc.) that produces an increased heart rate and respiratory volume (to meet the increased oxygen demands in the activated muscles) is called aerobic exercise. 55 Respiratory muscle training comprises breathing exercises, airway clearance techniques, and strengthening exercises of respiratory muscles. Aerobic exercises/ endurance training cannot improve the pressure-generating capacity of the inspiratory muscles. 9 Exercise intensity, duration, and frequency are essential factors for increasing the aerobic and RMT exercise capacities. 9, 61 This review observed that in most studies, the activity schedule, duration, and intensity of exercises (RR) were planned according to each patient's oxygen saturation level, Borg dyspnoea score, body temperature, respiratory rates, and mental status. The PFT parameters, FVC, and FEV1 largely depend on the status of the respiratory muscle function, lung compliance, and airway resistance. 55 In contrast, DLCO largely depends on lung parenchymal changes (blood flow and alveolar damage), provides information on the quantitive measurement of gas transfer in the lungs. 62 This meta-analysis could not show the consistent beneficial effects in all PFT parameters following RR training due to the variable nature of the disease course, severity, and resolution of lung pneumonia among the patients. Exercise training is the best available means of improving muscle function. 9 However, the exact mechanisms of improving exercise capacity and PFT parameters in the SARS population are still unclear. We speculate that aerobic exercises and RMT might have improved the respiratory muscle function, inspiratory volume, expiratory reserve capacity, and reduced airway obstruction, thereby reducing the dyspnoea, improving gas exchange and fatigue on physical activities, and increasing exercise capacity and PFT parameters in patients with SARS recovering from active disease. The previous reviews 9,42 , conducted on acute and chronic lung diseases, reported that the pulmonary rehabilitation program, as a whole or every activity, is a safe intervention, does not cause significant adverse events or increase mortality. Similarly, we also noticed that none of the studies had reported serious adverse events (including death) during the training program. However, few transient events (pulse rate, dyspnoea, drop of saturation rate) related to exercises were reported from a few patients, especially those who were admitted to ICU. However, a few aspects should be considered during the interpretation of this study's results. This systematic review demonstrated a positive association between respiratory rehabilitation and exercise capacity and PFT parameters in patients with SARS infection. Respiratory rehabilitation did not cause significant adverse events or increase mortality in the SARS population. Among the various program schedules, aerobic exercises and RMT could be used as important techniques to improve exercise capacity and lung function. However, additional RCT is needed comparing the respiratory rehabilitation program and conventional treatment to measure the accurate treatment efficacy in COVID-19 patients at different set-ups, both for short and long duration. 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Comp] 30.2(22.7-36.8) SF-36 [Mental Comp]38.5(30.1-52.8) 6MWD: Median 468 (IQR= 374-518) meter PFT Parameters 2-53.8) 6MWD: Median 557(IQR= 463-633) meter PFT Parameters Li Lei 2020 severe and critical SARS (COVID-19) 13 6MWD: NR PFT Parameters: NR ADL MBI: 75(30-100) 6-MWD: Not assessed PFT Parameters: Not assessed ADL (2 weeks weeks): Improved by [mean=17.22(SD= 43.78) meter] (p= 0.20) QoL (4 weeks) SF-36 COVID-19 patients, discharged 30 6-MWD: NR QoL SGRQ: 22.3(15.9) 6-MWD: (4 weeks) Significant improvement (p<0.001) PFT Parameters: (4 weeks) FVC: Significant improvement <0.05) FEV1: Significant improvement <0.05) QoL (4 weeks) SGRQ: improvement present BI: NR 6-MWD: (1 week) improved significantly (p<0.001) (n=22) ADL: (1 week) BI: improved significantly by 18 -2 week) BI: Significant improvement This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. In this study, there was no competing interests or financial benefits to the authors.