Efficacy of home-based inspiratory muscle training in patients post-covid-19: Protocol for a randomized clinical trial.

INTRODUCTION: Current evidence suggests the emergence of a novel syndrome (long COVID syndrome) due to sequels and persistent COVID-19 symptoms. Respiratory muscle training improves respiratory muscle strength, exercise capacity, diaphragm thickness, and dyspnea, especially in patients with decreased respiratory muscle strength. This study aims to evaluate the effectiveness of a protocol for home-based inspiratory muscle training to improve respiratory muscle strength, dyspnea, and quality of life of patients post-COVID-19. METHODS AND ANALYSES: This randomized, controlled, double-blind clinical trial will be conducted at the Instituto de Medicina Tropical of Universidade Federal do Rio Grande do Norte (Brazil). Sample size will be determined using maximal inspiratory pressure after a pilot study with five patients per group (total of 10 patients). Patients included in the study will be evaluated in three moments: pre-training (initial), post-training (three weeks), and retention (24 weeks). The sample will be randomized in two groups: active (IMT using 30% of IMT and load increase of 10% of initial IMT every week. Patients will perform 30 repetitions, twice a day (morning and afternoon), for seven consecutive days, and six weeks) and SHAM (IMT without load). The following measurements will be assessed: anthropometry, respiratory muscle strength, pulmonary volume and capacity, dyspnea, perception of effort and lower limb fatigue, handgrip strength, functional capacity, anxiety, depression, and functional status. After initial evaluation, all patients will receive a POWERbreathe® (POWERbreathe®, HaB Ltd, Southam, UK) device to perform the training. Normality will be verified using Shapiro-Wilk or Kolmogorov-Smirnov, according to the number of patients included. Variables presenting nonparametric distribution will be compared using Wilcoxon (intragroup analysis) and Mann-Whitney test (intergroup analysis), whereas repeated measures two-way ANOVA will be performed in case of parametric distribution. Dunn's post hoc test will be used to identify significant differences in the two-way ANOVA test. PRIMARY OUTCOMES: Respiratory muscle strength, dyspnea, and quality of life of post-COVID-19 patients. SECOND OUTCOMES: Pulmonary function, dyspnea, exercise tolerance, handgrip strength, anxiety, depression, and functional status. TRIAL REGISTRATION: Trial register number NCT05077241.

Effect of a home-based inspiratory muscle training programme on functional capacity in postdischarged patients with long COVID: the InsCOVID trial.

BACKGROUND: Fatigue and exercise intolerance are the most common symptoms in patients with long COVID. AIMS: This study aimed to evaluate whether a home-based inspiratory muscle training (IMT) programme improves maximal functional capacity in patients' long COVID after a previous admission due to SARS-CoV-2 pneumonia. METHODS: This study was a single-centre, blinded assessor, randomised controlled trial. Twenty-six patients with long COVID and a previous admission due to SARS-CoV-2 pneumonia were randomly assigned to receive either a 12-week IMT or usual care alone (NCT05279430). The physiotherapist and participants were not blinded. Patients allocated to the IMT arm were instructed to train at home twice daily using a threshold inspiratory muscle trainer and to maintain diaphragmatic breathing during the training session. The usual care arm received no intervention.The primary endpoint was the change in peak oxygen consumption (peakVO2). Secondary endpoints were changes in quality of life (QoL), ventilatory efficiency and chronotropic response during exercise (evaluated by chronotropic index-CIx- formula). We used linear mixed regression analysis for evaluating changes in primary and secondary endpoints. RESULTS: The mean age of the sample and time to first visit after discharge were 50.4±12.2 years and 362±105 days, respectively. A total of 11 (42.3%) were female. At baseline, the mean of peakVO2, ventilatory efficiency and CIx were 18.9±5 mL/kg/min, 29.4±5.2 and 0.64±0.19, respectively. The IMT arm improved their peakVO2 significantly compared with usual care (+Δ 4.46 mL/kg/min, 95% CI 3.10 to 5.81; p<0.001). Similar positive findings were found when evaluating changes for CIx and some QoL dimensions. We did not find significant changes in ventilatory efficiency. CONCLUSION: In long COVID patients with a previous admission due to SARS-CoV-2 pneumonia, IMT was associated with marked improvement in exercise capacity and QoL. TRIAL REGISTRATION NUMBER: NCT05279430.

Pilot study of physiotherapist-led versus music therapist-led breathing control exercises for young adults living with breathing pattern disorder: a randomised controlled trial protocol.

INTRODUCTION: Breathing pattern disorder (BPD) is an abnormal breathing pattern associated with biochemical, biomechanical and psychophysiological changes. While physiotherapy is often offered, limited evidence-based therapies for BPD are available. Music therapy-based singing exercises have been shown to improve quality of life for individuals with respiratory conditions and may also be beneficial for individuals living with BPD. No study has previously compared these participatory interventions in the treatment of people living with BPD. METHODS AND ANALYSIS: This is a study protocol for an assessor blinded 1:1 randomised controlled trial and qualitative interview study. Forty participants aged 18-40 years who score at least 19 on the Nijmegen Questionnaire (NQ) and do not have any underlying respiratory conditions will be recruited. Participants will be randomised to receive either physiotherapy-led or music therapy-led breathing exercises for 6 weeks. The primary outcome will be between-group difference in NQ post-intervention. Semistructured interviews with a purposive sample of participants will be performed. Qualitative data will be analysed using thematic analysis to better understand participants' intervention and trial experiences. ETHICS AND DISSEMINATION: This study has received ethical approval by Brunel University London College of Health, Medicine and Life Science's Research Ethics Committee (32483-MHR-Mar/2022-38624-3). The anonymised completed dataset will be made available as an open-access file via Brunel University London Figshare and the manuscript containing anonymised patient data will be published in an open-access journal. TRIAL REGISTRATION NUMBER: This trial is registered on the Open Science Framework Registry (https://osf.io/u3ncw).

Pulmonary and Functional Rehabilitation Improves Functional Capacity, Pulmonary Function and Respiratory Muscle Strength in Post COVID-19 Patients: Pilot Clinical Trial.

BACKGROUND: Patients affected by COVID-19 may develop an impaired lung function, with reduced lung capacities and volumes, respiratory muscle weakness, changes in radiographic and tomographic findings, limitations in exercising, decreased functional capacity, depression, anxiety and reduced quality of life. Thus, we aimed to analyze the effects of a pulmonary and functional rehabilitation program on the functional capacity, lung function and respiratory muscle strength in patients who were affected by COVID-19 syndrome. METHODS: This is a pilot clinical trial, composed of post-COVID-19 patients with mild, moderate or severe involvement, in which, they underwent a pulmonary and functional rehabilitation program. Patients were evaluated for functional capacity by the 6 min walk test, pulmonary function by spirometry, respiratory muscle strength by manovacuometry, handgrip strength by dynamometry, quality of life by the COPD Assessment Test and functional status by the PCFS. After the initial assessments, the patients performed the rehabilitation protocol in 16 sessions (inspiratory muscle training, aerobic exercise and peripheral muscle strength) and, at the end, they were evaluated again. RESULTS: A total of 29 patients completed the program (12.7 ± 2.7 sessions). The functional capacity increased in meters walked from 326.3 ± 140.6 to 445.4 ± 151.1 (p < 0.001), with an increase in the predicted value from 59.7% to 82.6% (p < 0.001). The lung function increased in liters from 2.9 ± 0.8 to 3.2 ± 0.8 (p = 0.004) for forced vital capacity and from 2.5 ± 0.7 to 2.7 ± 0.7 (p = 0.001) for forced expiratory volume in the first second. The respiratory muscle strength increased in cmH2O from 101.4 ± 46.3 to 115.8 ± 38.3 (p = 0.117) for inspiratory pressure and from 85.8 ± 32.8 to 106.7 ± 36.8 (p < 0.001) for expiratory pressure. CONCLUSIONS: The pulmonary and functional rehabilitation program provided an improvement in the functional capacity, pulmonary function and respiratory muscle strength in post-COVID-19 patients, restoring their quality of life.

Influence of Manual Diaphragm Release Technique Combined with Inspiratory Muscle Training on Selected Persistent Symptoms in Men with Post-Covid-19 Syndrome: A Randomized Controlled Trial.

OBJECTIVE: To determine whether the addition of manual diaphragm release to an inspiratory muscle training programme is more  effective than inspiratory muscle training alone in reducing blood pressure, dyspnoea, fatigue, and aerobic performance capacity in men with post-COVID-19 syndrome. DESIGN: A prospective, randomized-controlled trial. SETTING: Chest Disease Department, Outpatient Clinic, Cairo University, Egypt. PARTICIPANTS: Fifty-two men with post-COVID-19 syndrome were allocated randomly to the study and control groups. INTERVENTION: The study group underwent diaphragm release plus inspiratory muscle training, whereas the control group received inspiratory muscle training only. OUTCOME MEASURES: All patients were assessed with the following measures at baseline and 6 weeks postintervention: maximum static inspiratory pressure for inspiratory muscle strength, peripheral arterial blood pressure, Modified Medical Research Council scale for dyspnoea, Fatigue Severity Scale, serum lactate level, and 6-min walk test distance for aerobic performance. RESULTS: All outcome measures showed a significant improvement in favour of the study group (p < 0.001) over the control group. However, maximum static inspiratory pressure increased significantly, by 48.17% (p < 0.001) in the study group with no significant change in the control group. CONCLUSION: Addition of manual diaphragm release to an inspiratory muscle training programme potentiates the role of inspiratory muscle training in the management of men with symptomatic post-COVID-19 syndrome.

Telematics program of breathing exercises and mindfulness for post-coronavirus disease 2019 patients.

OBJECTIVE: The coronavirus disease 2019 pandemic is an economic, social, and health challenge. During the coronavirus disease 2019 lockdown, a telematics platform for respiratory physiotherapy and mindfulness was created, aiming to reduce dyspnea and anxiety and to increase quality of life in post-coronavirus disease 2019 patient. METHODS: A quasi-experimental study was performed on post-coronavirus disease 2019 patients, with breathing exercises and mindfulness with remote supervision by a respiratory physiotherapist. Dyspnea on exertion (Mahler Scale), quality of life (EuroQol-5D score), and anxiety (State-Trait Anxiety Inventory questionnaire) were measured before and after the rehabilitation program. RESULTS: A total of 20 subjects completed the program, with a significant decrease in the measures of dyspnea on exertion (p<0.001), state anxiety (p=0.004), and trait anxiety (p=0.001) and a significant increase in quality of life (p=0.016). CONCLUSIONS: Coronavirus disease 2019 should be treated using a multidisciplinary approach that includes respiratory rehabilitation. At present, there are few studies on respiratory rehabilitation and mindfulness in post-coronavirus disease 2019 patients. The results of this study showed that the implementation of breathing exercises and mindfulness with remote supervision was effective in decreasing dyspnea and anxiety and in increasing quality of life in post-coronavirus disease 2019 patients during confinement.

Effects of mental health interventions among people hospitalized with COVID-19 infection: A systematic review of randomized controlled trials.

OBJECTIVE: We evaluated the effects of mental health interventions among people hospitalized with COVID-19. METHODS: We conducted a systematic review and searched 9 databases (2 Chinese-language) from December 31, 2019 to June 28, 2021. Eligible randomized controlled trials assessed interventions among hospitalized COVID-19 patients that targeted mental health symptoms. Due to the poor quality of trials, we sought to verify accuracy of trial reports including results. RESULTS: We identified 47 randomized controlled trials from China (N = 42), Iran (N = 4) and Turkey (N = 1) of which 21 tested the efficacy of psychological interventions, 5 physical and breathing exercises, and 21 a combination of interventions. Trial information could only be verified for 3 trials of psychological interventions (cognitive behavioral, guided imagery, multicomponent online), and these were the only trials with low risk of bias on at least 4 of 7 domains. Results could not be pooled or interpreted with confidence due to the degree of poor reporting and trial quality, the frequency of what were deemed implausibly large effects, and heterogeneity. CONCLUSION: Trials of interventions to address mental health in hospitalized COVID-19 patients, collectively, are not of sufficient quality to inform practice. Health care providers should refer to existing expert recommendations and standard hospital-based practices. REGISTRATION: PROSPERO (CRD42020179703); registered on April 17, 2020.

Breathing exercises versus strength exercises through telerehabilitation in coronavirus disease 2019 patients in the acute phase: A randomized controlled trial.

OBJECTIVE: To compare the effectiveness of two different exercise-based programs through telerehabilitation in patients with coronavirus disease 2019. DESIGN: Randomized, controlled, parallel, double-blinded, three-arm clinical trial. SETTING: Patients' homes through telerehabilitation devices. SUBJECTS: Subjects with coronavirus disease 2019 in the acute phase. INTERVENTIONS: Subjects were divided into three groups: breathing exercises group, strength exercises group or no treatment/control group. MAIN MEASURES: We analysed visual analogue scale for fatigue, 6-minute walking test, 30-seconds sit-to-stand test, multidimensional dyspnoea-12 questionnaire and Borg scale at baseline and 14 days later. RESULTS: From 93 subjects recruited, 88 were enrolled, and 77 patients (mean [SD] age 39.40 [11.71]) completed the 14-days intervention and were included in the analysis: 26 in strength exercises group, 29 in breathing exercises group and 22 in control group. The intergroup analysis shows significant differences between the study groups and control group in all variables (p < 0.05); Borg scale, multidimensional dyspnoea-12 questionnaire (pre-post intervention score: strength exercises group: 7.85 [6.82] - 4.54[4.82], breathing exercises group: 11.04 [6.49] - 5.32 [3.63], control group: 10.27 [6.49] - 10.59[6.58]), visual analogue scale for fatigue, 6-minute walking test and 30-seconds sit-to-stand test (pre-post intervention score: strength exercises group: 12.19 [4.42] - 13.58 [5.37], breathing exercises group: 11.18 [3.42] - 12.79 [4.00], control group: 10.45 [2.15] - 9.86[1.88]). The greatest effect sizes were found in the variables Borg Scale (R2 = 0.548) and multidimensional dyspnoea-12 questionnaire (R2 = 0.475). CONCLUSIONS: Strength exercises group and breathing exercises group obtained significant improvements in fatigue, dyspnoea, perceived effort, and physical state, compared to control group, although the greatest benefits were found for dyspnoea and aerobic capacity in breathing exercises group.

Prehabilitation for Bariatric Surgery: A Randomized, Controlled Trial Protocol and Pilot Study.

Bariatric surgery is the most efficacious treatment for obesity, though it is not free from complications. Preoperative conditioning has proved beneficial in various clinical contexts, but the evidence is scarce on the role of prehabilitation in bariatric surgery. We describe the protocol and pilot study of a randomized (ratio 1:1), parallel, controlled trial assessing the effect of a physical conditioning and respiratory muscle training programme, added to a standard 8-week group intervention based on therapeutical education and cognitive-behavioural therapy, in patients awaiting bariatric surgery. The primary outcome is preoperative weight-loss. Secondary outcomes include associated comorbidity, eating behaviour, physical activity, quality of life, and short-term postoperative complications. A pilot sample of 15 participants has been randomized to the intervention or control groups and their baseline features and results are described. Only 5 patients completed the group programme and returned for assessment. Measures to improve adherence will be implemented and once the COVID-19 pandemic allows, the clinical trial will start. This is the first randomized, clinical trial assessing the effect of physical and respiratory prehabilitation, added to standard group education and cognitive-behavioural intervention in obese patients on the waiting list for bariatric surgery. Clinical Trial Registration: NCT0404636.

Inspiratory muscle training for recovered COVID-19 patients after weaning from mechanical ventilation: A pilot control clinical study.

BACKGROUND: To the best of our knowledge, no studies have evaluated the effects of inspiratory muscle training (IMT) on recovered COVID-19 patients after weaning from mechanical ventilation. Therefore, this study assessed the efficacy of IMT on recovered COVID-19 patients following mechanical ventilation. METHODS: Forty-two recovered COVID-19 patients (33 men and 9 women) weaned from mechanical ventilation with a mean age of 48.05 ±â€Š8.85 years were enrolled in this pilot control clinical study. Twenty-one patients were equipped to 2-week IMT (IMT group) and 21 matched peers were recruited as a control (control group). Forced vital capacity (FVC%), forced expiratory volume in 1 second (FEV1%), dyspnea severity index (DSI), quality of life (QOL), and six-minute walk test (6-MWT) were assessed initially before starting the study intervention and immediately after intervention. RESULTS: Significant interaction effects were observed in the IMT when compared to control group, FVC% (F = 5.31, P = .041, ηP2 = 0.13), FEV1% (F = 4.91, P = .043, ηP2 = 0.12), DSI (F = 4.56, P = .032, ηP2 = 0.15), QOL (F = 6.14, P = .021, ηP2 = 0.17), and 6-MWT (F = 9.34, P = .028, ηP2 = 0.16). Within-group analysis showed a significant improvement in the IMT group (FVC%, P = .047, FEV1%, P = .039, DSI, P = .001, QOL, P < .001, and 6-MWT, P < .001), whereas the control group displayed nonsignificant changes (P > .05). CONCLUSIONS: A 2-week IMT improves pulmonary functions, dyspnea, functional performance, and QOL in recovered intensive care unit (ICU) COVID-19 patients after consecutive weaning from mechanical ventilation. IMT program should be encouraged in the COVID-19 management protocol, specifically with ICU patients.

Breathing exercises and pranayamas to decrease perceived exertion during breath-holding while locked-down due to COVID-19 online randomized study.

AIM: to compare anulom vilom pranayama (AVP), kapal bhati pranayama (KBP), diaphragmatic breathing exercises (DBE), and pursed-lip breathing (PLB) for breath holding time (BHT) and rating of perceived exertion (RPE). Methods- Participants were assessed for BHT and RPE, before training on any one intervention using online platforms, for one week during lockdown from COVID-19.15 participants in each group total N = 60 at- (α - 0.05), (1- ß - 0.90) & (effect size - 0.55); were analysed. Results - AVP & DBE decreased RPE (p < 0.000). KBP & PLB did not decrease RPE as compared to AVP & DBE (p. > 0.05). DBE increased BHT more than KBP & PLB interventions (p < 0.05), but not more than AVP (p > 0.05). One-way ANOVA of four interventions revealed significant variation for RPE change (p < 0.05), for AVP. Conclusions - AVP reduces RPE maximally during breath-holding, whereas DPE increases BHT more.

A case for inspiratory muscle training in SCI: potential role as a preventative tool in infectious respiratory diseases like COVID-19.

INTRODUCTION: Respiratory complications (RC) are a leading cause of death after spinal cord injury (SCI) due to compromised immune function and respiratory muscle weakness. Thus, individuals with SCI are at high risk of developing COVID-19 related RC. Results of a SCI clinical trial showed a supervised respiratory muscle training (RMT) program decreased risk of developing RC. The feasibility of conducting unsupervised RMT is not well documented. Four publications (n = 117) were identified in which unsupervised RMT was performed. Significant improvements in respiratory outcomes were reported in two studies: Maximal Inspiratory and Expiratory Pressure (MIP40% and MEP25%, respectively), Peak Expiratory Flow (PEF9%), seated and supine Forced Vital Capacity (FVC23% and 26%, respectively), and Peak Cough Flow (28%). This review and case report will attempt to show that an inspiratory muscle training (IMT) home exercise program (HEP) is feasible and may prepare the respiratory system for RC associated with COVID-19 in patients with SCI. CASE PRESENTATION: A 23-year-old with tetraplegia (P1), history of mechanical ventilation, and hospitalization for RC, completed 27 IMT HEP sessions in one month. MIP and sustained MIP (SMIP) increased from baseline by 28% and 26.5%, respectively. Expiratory volumes and rates also improved (FVC, FEV1, and PEF: 11.7%, 8.3%, and 14.2%, respectively). DISCUSSION: The effects of COVID-19 on patients with SCI remains inconclusive, but recent literature and the results of this case suggest that unsupervised IMT is feasible and may limit the severity of RC in patients with SCI who contract COVID-19.

Modified rehabilitation exercises for mild cases of COVID-19.

BACKGROUND: Coronavirus disease 2019 (COVID-19) caused by a new Betacoronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is currently a global pandemic. Gathered clinicopathological evidence in COVID-19 patients shows that alveoli injuries and interstitial changes are the major mechanisms of impaired O2/CO2 exchange. Few rehabilitation exercises concerning COVID-19 patients were reported. Here, we present a modified version of rehabilitation exercises based on the underlying mechanism of the disease to mild cases of COVID-19. These exercises aimed to improve the pulmonary function of patients and ease the expectoration process. Additionally, an essential branch of Traditional Chinese Medicine (TCM) named acupressure was integrated into the exercises to facilitate the recovery and maintenance of pulmonary function. METHODS: From March 4, 2020 to May 5, 2020, a total of 60 COVID-19 patients who completed the full course of MRE were enrolled in this observational study. The diagnostic and classification criteria were based on the 7th edition of Diagnosis and Treatment Guideline of COVID-19 published by the National Health Commission of the People's Republic of China. We prospectively gathered patients' reported outcomes concerning respiration-related symptoms at four different time points, including: (I) at admission; (II) at the time of hospital discharge; (III) two weeks after discharge; (IV) four weeks after discharge. The reported respiratory symptoms included dry cough, productive cough, difficulty in expectoration, and dyspnea. RESULTS: In total, 60 confirmed mild COVID-19 cases were enrolled with a median age of 54 years old. The baseline prevalence for dry cough, productive cough, difficulty in expectoration, and dyspnea were 41.7%, 43.3%, 35.0%, and 50.0%, respectively. The pronounced decline in symptom prevalence was recorded over time. Interestingly, four weeks after discharge, we noticed a lower remission rate in productive cough and difficulty in expectoration. CONCLUSIONS: The modified rehabilitation exercises were retrieved from the Eight-Section Brocade, and are specifically designed for rehabilitation of COVID-19 patients at home or health facilities. Based on current findings on pronouncedly improved remission rate in respiratory symptoms, we recommend the MRE as suitable rehabilitation exercise to smooth respiration and ease the expectoration process in mild COVID-19 cases.

Therapeutic pulmonary telerehabilitation protocol for patients affected by COVID-19, confined to their homes: study protocol for a randomized controlled trial.

BACKGROUND: In December 2019, 27 cases of pneumonia, of unknown cause, were identified in the province of Hubei (China). The WHO declared the situation as a Public Health Emergency of International Concern, and it was finally declared a global pandemic on March 11, 2020. The Spanish Government obliges the entire population to remain confined to their homes, with the exception of essential basic services, to stop the spread of COVID-19. Home isolation implies a notable physical deconditioning. Telerehabilitation methods have reported positive experiences, and we propose to study in affected patients of COVID-19, due to the general house confinement of the entire Spanish population. METHODS: Patients will be recruited in the regions of Andalusia, Murcia, and Valencia (Spain). Patients will remain confined to their homes, and there, they will carry out their assigned exercise program, which will be controlled telematically. Evaluators will attend to carry out all measurements at the beginning, during, and end of the study, telematically controlled. The patients will be randomly divided into three groups, two of them will perform a home exercise program (breathing exercises or non-specific exercises for muscle toning) and the third group will perform sedentary activities, using mental activation techniques, and will act as a sham group. We will evaluate respiratory variables and other variables of the physical state through physical tests, effort, and perceived fatigue. The data will be statistically analyzed, and the hypotheses will be tested between the groups, using the SPSS software, v.24, considering a 95% confidence interval. DISCUSSION: We will analyze the results, in terms of the level of fatigue and perceived exertion, physical health, and maintenance of respiratory activity of two types of exercise programs, toning and respiratory, applied in patients affected by COVID-19 during the period of home confinement. We intend to investigate a field not previously studied, such as the repercussion of carrying out a toning and respiratory exercise program in these patients, in historical circumstances that no one had previously observed in Spain, since the general population has never been forced to remain confined in their homes, due to a pandemic infection, by a coronavirus (COVID-19). Observing the effects that these two home exercise programs could produce in patients infected with COVID-19, we will try to better analyze and understand the mechanisms that are associated with the worsening of breathing in this type of patient. TRIAL REGISTRATION: Brazilian Clinical Trial Registry RBR-6m69fc . Registered on March 31, 2020.