Telerehabilitation and Face-to-face Rehabilitation on COVID-19 Survivors

Study Overview
=================
Brief Summary
-----------------
INTRODUCTION: As this is a new disease, the short- and long-term consequences for patients with COVID-19 are still unclear. The use of sedatives, as well as prolonged rest, can lead to musculoskeletal damage, including decreased muscle strength and physical function. Thus, rehabilitation after this disease is a key component in continuing patient care. OBJECTIVE: To verify the effects of face-to-face cardiac rehabilitation and telerehabilitation on tolerance to the maximum and submaximal exercise, lung function, fatigue intensity and quality of life of COVID-19 survivors. METHODS: This is a longitudinal, intervention study. Primary outcomes will be maximum and submaximal functional capacity, intensity and impact of fatigue, while secondary outcomes will be lung function and quality of life. EXPECTED RESULTS: This work will bring important information to the scientific community and health professionals, about the best forms of intervention and its repercussions on the surviving individuals of COVID-19.

Official Title
-----------------
Telerehabilitation and Face-to-face Rehabilitation on Tolerance to Exercise and Quality of Life of COVID-19 Survivors: a Study Protocol

Conditions
-----------------
Covid19, Exercise Tolerance, Quality of Life, Lung Function, Fatigue Intensity

Intervention / Treatment
-----------------
* Other: Face-to-face rehabilitation
* Other: Telerehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults of both genders; With a diagnosis of COVID-19 confirmed by a laboratory through RT-PCR means; Have to access to the internet and some device (smartphone, computer or notebook) that allows them to participate in the call centre. Exclusion Criteria: Individuals with orthopaedic or neurological diseases; Individuals with difficulties in understanding and that present psychological changes that make it difficult or impossible to understand the information presented.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Face-to-face rehabilitation and Telerehabilitation<br>The Face-to-face rehabilitation and Telerehabilitation protocol will consist of flexibility exercises, aerobic and resistance training, with two sessions per week. | Other: Face-to-face rehabilitation<br>* Aerobic training will be performed with 60% to 80% of the maximum VO2 obtained through the CPET. The exercise will be performed on the treadmill, with a total time of 40 minutes, with 5 minutes of warm-up, 30 minutes of conditioning, 5 minutes of cooling down. Resistance training will be performed for upper and lower limbs and the load used in the exercises will be 60% of the maximum repetition test (1RM), with load progression every six sessions. The exercises are performed in three series of 12 repetitions.<br>Other: Telerehabilitation<br>* The telerehabilitation protocol will consist of stretching the muscles of the upper and lower limbs and accessory muscles of breathing. The conditioning phase will consist of stationary walking, side running, jumping jump and stationary running, 3 times of 40 seconds with a 30-second passive rest interval between them. Resistance training will be applied to the muscles of the upper limbs and lower limbs, with specific exercises for each musculature, using elastic bands as resistance.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum functional capacity | Evaluated by the cardiopulmonary exercise test by measuring the maximum oxygen consumption | 12 weeks | 
| Submaximal functional capacity | Evaluated by the six-minute walk test | 12 weeks | 
| Intensity and impact of fatigue | Evaluated by the Fatigue pictogram questionnaire, an ordinal scale composed of two questions graded in 5 captioned illustrations that assess the intensity (not at all tired, a little tired, moderately tired, very tired and extremely tired) and the impact of fatigue (I manage to do everything I normally do I do, I can do almost everything I usually do, I can do some of the things I usually do, I just do what I have to do and I can do very little). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry | Number of patients with ventilatory disorder assessed by spirometry | 12 weeks | 
| Quality of life assessment: Short Form-36 questionnaire | In this questionnaire, a score of zero corresponds to the worst general health status and the one hundred best health status. | 12 weeks |