Dataset Information

Efficacy of an asynchronous telerehabilitation program in post-COVID-19 patients: A protocol for a pilot randomized controlled trial.

ABSTRACT:

Background

About 40% of patients who have had COVID-19 still have symptoms three months later whereas a 10% may experience physical and/or psychological consequences two years later. Therefore, it is necessary to perform preventive interventions when patients are discharged from the hospital to decrease the aforementioned sequelae. The purpose of this pilot-controlled trial will be to determine the efficacy of a rehabilitation program on functional status and psychosocial factors for post-COVID-19 patients when it is delivered through a tele-care platform versus a booklet-based rehabilitation.

Methods

The estimated sample size will be of 50 participants who have been discharged after COVID-19 and have a level of fatigue equal or greater than 4 on the Fatigue Severity Scale. The primary outcome will be the severity of fatigue. Participants will be randomly allocated to an "asynchronous telerehabilitation group" or to a "booklet-based rehabilitation group". Treatment in both groups will be the same and will consist of a combination of therapeutic exercise and an educative program. Treatment outcomes will be evaluated the last day of the intervention and at three- and six-months follow-up.

Discussion

The telerehabilitation intervention appears to be a viable and efficacy option in decreasing severe fatigue and other fitness variables such as strength and aerobic capacity, similar to other traditional rehabilitation formats such as through an explanatory booklet.

Clinical trial registration

This trial has been prospectively registered at clinialtrials.gov identifier: NCT04794036.

SUBMITTER: Carpallo-Porcar B

PROVIDER: S-EPMC9295945 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

Efficacy of an asynchronous telerehabilitation program in post-COVID-19 patients: A protocol for a pilot randomized controlled trial.

Carpallo-Porcar Beatriz B Romo-Calvo Laura L Pérez-Palomares Sara S Jiménez-Sánchez Carolina C Herrero Pablo P Brandín-de la Cruz Natalia N Calvo Sandra S

PloS one 20220719 7

<h4>Background</h4>About 40% of patients who have had COVID-19 still have symptoms three months later whereas a 10% may experience physical and/or psychological consequences two years later. Therefore, it is necessary to perform preventive interventions when patients are discharged from the hospital to decrease the aforementioned sequelae. The purpose of this pilot-controlled trial will be to determine the efficacy of a rehabilitation program on functional status and psychosocial factors for pos ...[more]

PMID: 35853037

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Project description:BackgroundThe Cochrane review on the effectiveness of speech and language therapy for aphasia following stroke suggests intensity of therapy is a key predictor for outcome. Current aphasia services cannot provide intervention at the intensity observed within trial contexts because of resource limitations. Telerehabilitation could widen access to speech-language pathologists (SLPs) in geographically remote contexts and reduce the time spent on travel by the therapist and patient. The current academic literature within this field is in its infancy, with few trials of speech and language therapy (SLT) delivered by videoconference. Our pilot randomized controlled trial (RCT) will explore feasibility aspects and effectiveness of telerehabilitation for aphasia in addition to standard SLT.Method/designOur study is a pragmatic, exploratory, pilot randomized controlled trial, where participants will be randomized to a telerehabilitation group or a control group. Both groups receive standard SLT (usual care) but the telerehabilitation group receives an additional 5 h of telerehabilitation per week over 4 weeks through videoconference. This additional telerehabilitation focuses on spoken language with an emphasis on word naming. We aim to include 40 patients in each group, with inclusion criteria being aphasia any time post stroke. Participants will be assessed blindly at pre-randomization (baseline), and 4 weeks and 4 months after randomization. The primary endpoint is naming ability 3 months after the completed intervention, measured by the Norwegian Basic Aphasia Assessment (NGA) naming subtest. Secondary endpoints include other subtests of the NGA, the VAST (Verb and Sentence Test) subtest sentence production, Communicative Effectiveness Index (CETI) and the Stroke and Aphasia Quality of Life scale (SAQOL-39). Experiences of patients and SLPs with telerehabilitation are assessed using questionnaires and semi-structured interviews. Statistical between group comparisons will be in line with an intention-to-treat analysis.DiscussionThis pilot RCT of intensive language training by videoconference will contribute new scientific evidence to the field of aphasia telerehabilitation. Here, we describe our trial which will explore the feasibility of telerehabilitation for aphasia as an intervention, our choice of primary and secondary outcome measures and proposed analyses. Our trial will provide information for the development and delivery of future definitive RCTs.Trial registrationClinicalTrials.gov, ID: NCT02768922 . Registered on 11 May 2016. Last updated on 17 November 2017.

Project description:ObjectiveCOVID-19 has led to significant morbidity and mortality globally. Post-COVID sequelae can persist beyond the acute and subacute phases of infection, often termed post-COVID syndrome (PCS). There is limited evidence on the appropriate rehabilitation for people with PCS. The aim of this study is to evaluate the effect on exercise capacity, symptoms, cognition, anxiety, depression, health-related quality of life, and fatigue of a 4-week, twice-weekly supervised pulmonary telerehabilitation program compared with usual medical care for people with PCS with persistent respiratory symptoms.MethodsThe study will be a multi-site randomized controlled trial with assessor blinding. Participants with confirmed previous COVID-19 infection and persistent respiratory symptoms who attend a post-COVID respiratory clinic will be randomized 1:1 to either an intervention group of 4 weeks, twice-weekly pulmonary telerehabilitation or a control group of usual medical care. Participants in the control group will be invited to cross-over into the intervention group after the week 4 assessment. Primary outcome: exercise capacity measured by the 1-minute sit-to-stand test. Secondary outcomes: 5 repetition sit-to-stand test; Montreal Cognitive Assessment; COVID-19 Yorkshire Rehabilitation Scale; Chronic Obstructive Pulmonary Disease Assessment Test; 36-Item Short-Form Health Survey; Hospital Anxiety and Depression Scale; Fatigue Severity Scale; and the Kessler Psychological Distress Scale. Outcomes will be collected at baseline, after 4-weeks intervention or control period, after intervention in the cross-over group, and at 12-month follow-up.ImpactResearch into effective rehabilitation programs is crucial given the substantial morbidity associated with PCS and the lack of long-term data for COVID-19 recovery. A short-duration pulmonary telerehabilitation program, if effective compared with usual care, could inform practice guidelines and direct future clinical trials for the benefit of individuals with persistent respiratory symptoms post-COVID.

Project description:IntroductionCOVID-19 pandemic has challenged healthcare systems worldwide. The aim of this study was to assess the results of a Respiratory Telerehabilitation Program implemented to patients post-COVID-19 in postacute phase of mild to critical course of COVID-19 who had persistent respiratory symptoms and had not received any vaccination. The intervention was performed during confinement.MethodsA quasi-experimental nonrandomized study was conducted in Spain during confinement. Respiratory Telerehabilitation Program was guided by a specialized physical therapist through a web platform (Zoom by Zoom Video Communications, San Jose, CA, USA). Participants were recruited through social webs. Outcome measures included respiratory rate, heart rate, percutaneous oxygen saturation, Mahler's Dyspnea Index, anxiety status, and quality of life [EuroQol 5 Dimension 5 (EQ-5D)].ResultsA total number of 148 participants were recruited, with a final number of 100 participants completing the protocol (50 experimental group (EG)/50 control group (CG)). A total of 500 telerehabilitation sessions were performed for this study. In the EG, pre-post intervention comparative analysis showed significative changes in Mahler's functional dyspnea (p < 0.001), the State-Trait Anxiety Inventory (p < 0.001), oxygen saturation (p < 0.001), heart rate (p < 0.001), quality-of-life questionnaire (p < 0.001), and respiratory rate (p < 0.001). Participants in the CG showed an improvement in all the variables, but the differences were not statistically significant except in Mahler's functional dyspnea (p = 0.001) and in the quality-of-life questionnaire (p = 0.043). Percentage changes in pre-post intervention were calculated and compared between EG and CG. There were statistically significative differences in all the outcomes in favor of the EG.ConclusionThe implementation of a pulmonary telerehabilitation program for COVID-19 not vaccinated survivors in postacute phase with mild to critical course of COVID-19 with respiratory sequelae has proven its benefits in cardiorespiratory variables and dyspnea-related anxiety.

Project description:BackgroundIn 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.MethodsPatients 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.DiscussionWe 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 registrationBrazilian Clinical Trial Registry RBR-6m69fc . Registered on March 31, 2020.

Project description:BackgroundNumerous recommendations from pulmonary scientific societies indicate the need to implement rehabilitation programs for patients after COVID-19. The aim of this study was to propose an innovative comprehensive intervention based on a hospital-based pulmonary rehabilitation program for individuals with post-acute sequelae of COVID-19.MethodsIt was decided to evaluate two forms of hospital rehabilitation: traditional and one provided through virtual reality. Preliminary results are based on a group of 32 patients (20 female and 12 male), of average age 57.8 (4.92) years in the period of 3-6 months after the initial infection. Primary outcomes included analysis of lung function, exercise performance and stress level. A 3-week, high-intensity, five-times per week pulmonary rehabilitation program was designed to compare the effectiveness of a traditional form with a VR-led, novel form of therapy.ResultsThe analysis of the results showed a statistically significant improvement in both groups with regard to exercise performance expressed as 6MWT distance. Moreover, a statistically significant decrease in dyspnoea levels following the 6MWT was also noted in intergroup comparison, but the between-group comparison revealed non-statistically significant changes with low effect size. Regarding lung function, the analysis showed essentially normal lung function at baseline and a non-statistically significant improvement after the completion of the rehabilitation program. The analysis of the stress level showed a statistically significant improvement in both groups within the inter-group comparison, yet the between-group comparison of deltas values showed a non-significant difference with low effect size.ConclusionA 3-weeks inpatients pulmonary rehabilitation program led to improvement of the exercise performance of people with post-acute sequelae of COVID-19, but not lung function. Furthermore, the program was shown to reduce patients' stress levels. A comparison of the traditional form of rehabilitation to the novel form using VR, shows similar effectiveness in terms of exercise performance and stress levels.

Dataset Information

Efficacy of an asynchronous telerehabilitation program in post-COVID-19 patients: A protocol for a pilot randomized controlled trial.

Background

Methods

Discussion

Clinical trial registration

Publications

Efficacy of an asynchronous telerehabilitation program in post-COVID-19 patients: A protocol for a pilot randomized controlled trial.

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