Clinical trial NCT04794036: Efficacy of an Asynchronous Telerehabilitation Programme in Post-COVID-19 Patient
Official title: Efficacy of an Asynchronous Telerehabilitation Programme in Post-COVID-19 Patients: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus
Fatigue
Musculoskeletal Complication
Keywords: Coronavirus
Telerehabilitation
Exercise Therapy
Education
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
Collaborators: name: Hospital Real Nuestra Señora de Gracia
name: Hospital Royo Villanova
First posted: 2021-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: SARS-CoV-2 is the coronavirus responsible for developing the disease known as COVID-19. Its evolution can range from an asymptomatic course, to rapidly evolve and cause an acute respiratory syndrome. In addition to respiratory symptoms, is also has an impact on the neuromuscular systems. Therefore, the additional inactivity for hospitalization, negatively influences the loss of muscular, cardiovascular and metabolic fitness. In view of this, it is recommended that early post-acute rehabilitation be continued after the hospital phase to increase levels of physical activity, which can also be continued with long-term telerehabilitation.

This project would offer a free service of asynchronous physical telerehabilitation for the patient that is easy to implement and follow up.

For this purpose, patients will be recruited at the time of discharge from the Hospital Provincial Nuestra Señora de Gracia (HPNSG) and the Hospital Royo Villanova (HRV) in Zaragoza and two intervention groups with the same physical therapy and educational programme will be carried out. The experimental group will be carried out by means of home telerehabilitation, while the control group will receive the programme in an explanatory booklet.

The main objective is to analyse the preliminary efficacy on physical fitness of a 12-week physical therapy and therapeutic education programme using asynchronous telerehabilitation in post-COVID-19 patients, and to compare its effects with patients who have undergone the same programme, but in a non-telematic format.

The secondary objective is to analyze the feasibility of a physical home-based asynchronous telerehabilitation programme in post-COVID-19 patients.

Hypothesis: the implementation of a 12-week programme of physical therapy and therapeutic education using asynchronous telerehabilitation software is feasible and preliminarily effective in increasing physical fitness as well as adherence to treatment, and in the improvement of psychosocial factors.

Detailed description: At the first phase, an observational study aims to investigate the physical and psychological status of patients after hospital discharge.

At the second phase, a feasibility pilot study with a single-blinded randomized clinical trial design with volunteer patients admitted to hospital and recruited at the time of discharge by COVID-19 will evaluate a physiotherapy programme. There will be an intervention group (asynchronous telerehabilitation at home) and a control group (home rehabilitation by means of an explanatory leaflet). The intervention will be carried out for 12 weeks with a follow-up at 3 and 6 months.

Intervention:

The physical rehabilitation programme will be designed with three levels of intensity of aerobic, strength and respiratory exercises, and a list of recommendations for self-management of the sequelae of the COVID-19.

The intervention will last for a total of 12 weeks at home (three days a week for 45-60 minutes a day) with a biweekly phone check-up.

All patients will be provided with the same physical rehabilitation and educational programme, with each allocation group differing in the format of the prescription.

Experimental group

A programme with exercise videos and health recommendations will be prescribed through a telerehabilitation platform to improve fatigue and fitness resulting from COVID-19. The application will be installed on patients' mobile phones and its use will be explained to them so that they can carry out the programme from their homes.

Control group The control group will receive a paper booklet with clear pictures and descriptions of the exercise and educative programme to improve fatigue and fitness.

Assessment:

Fatigue will be assessed with the fatigue severity scale (FSS). Functional capacity will be measured through operation: with the Post-COVID Functional Status Scale (PCFS), the strength with the 30" sit-to-stand (STST), the 30" arm curl test (ACT), and through aerobic capacity with de six minutes walking test (6MWT).

Psychosocial factors will be measured with the general self-efficacy scale (GSES), the depression and anxiety scale (DASS-21), the behavioral regulation questionnaire in sport (BRSQ) and the multidimensional scale of perceived social support (MSPSS).

Quality of life will be measured with the quality of life scale (SF-12).

Adherence and engagement be measured by diary recording and satisfaction with a brief interview.

Outcome measures:

Fatigue, functional status post-COVID-19, strength, aerobic capacity, anxiety and depression, behavior in sport, perceived social support and quality of life will be evaluated before intervention, after intervention (12 weeks) at 3 and 6 months for follow-up.

Adherence and satisfaction will be evaluated after intervention (12 weeks) and during intervention (each 15 days).

Eligibility criteria: Inclusion Criteria:

* Age range 18-75 years.
* Patients who have been hospitalized for more than 5 days for COVID-19.
* Patients who have been discharged from the hospital and present a fatigue score higher than 4 points on average on the fatigue severity scale (FSS).
* Independent walking, even with the use of any technical aid.
* Have signed the informed consent form.

Exclusion Criteria:

* Patients with central and/or peripheral neurological diseases that prevent the programme from being followed.
* Patients with rheumatic pathology or acute musculoskeletal injury in their medical history.
* Patients with severe respiratory failure: SaO2 less than 90% or respiratory rate \>30.
* Patients with cardiac comorbidities or signs of cardiovascular inestability as uncontrolled arrythmia, blood pressure and/or effort angina.
* Patients with other contraindicated pathology for moderate-intensity aerobic or strength exercise.
* Patients without access to mobile internet or computer with internet at home.
* Patients with a score ≤24 on the Mini-Cognitive Examination (MEC).
* Patients who are unable to follow oral and written instructions in Spanish.

Primary outcomes:
measure: Fatigue Severity Level
timeFrame: Pre-intervention (day 1); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).
Secondary outcomes:
measure: Adherence
timeFrame: Pre-intervention (day 1); during intervention (every 15 days during intervention); after intervention (day 84).
measure: Engagement
timeFrame: Pre-intervention (day 1); during intervention (every 15 days during intervention); after intervention (day 84).
measure: Satisfaction level
timeFrame: Pre-intervention (day 1); during intervention (every 15 days during intervention); after intervention (day 84).
measure: Incidents
timeFrame: Pre-intervention (day 1); during intervention (every 15 days during intervention); after intervention (day 84).
measure: Maximum Leg Strength Endurance
timeFrame: Pre-intervention (1 day); after intervention (day 84).
measure: Maximum Arm Strength Endurance
timeFrame: Pre-intervention (1 day); after intervention (day 84).
measure: Submaximum Aerobic Capacity Walking
timeFrame: Pre-intervention (1 day); after intervention (day 84).
measure: Post-COVID Functional Status
timeFrame: Pre-intervention (1 day); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention)
measure: Depression, Anxiety and Stress
timeFrame: Pre-intervention (1 day); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).
measure: Self-efficacy
timeFrame: Pre-intervention (1 day); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).
measure: Behavior in sport
timeFrame: Pre-intervention (1 day); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).
measure: Perceived social support
timeFrame: Pre-intervention (1 day); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).
measure: Quality of Life Assessment
timeFrame: pre-intervention (1 day); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Real Nuestra Señora de Gracia
city: Zaragoza
country: Spain
facility: Hospital Royo Villanova
Study officials:
affiliation: Universidad San Jorge
name: Carolina Jiménez Sánchez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad San Jorge
name: Sandra Calvo, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carpallo-Porcar B, Romo-Calvo L, Perez-Palomares S, Jimenez-Sanchez C, Herrero P, Brandin-de la Cruz N, Calvo S. Efficacy of an asynchronous telerehabilitation program in post-COVID-19 patients: A protocol for a pilot randomized controlled trial. PLoS One. 2022 Jul 19;17(7):e0270766. doi: 10.1371/journal.pone.0270766. eCollection 2022.