This randomized clinical trial aims to compare the effects of a 12-week behavioralphysical activity intervention (i.e., physical activity coaching) with usual care (i.e.,World Health Organization recommendations for being physically active) in patients withpost-COVID-19 (i.e., patients who suffered from COVID-19 at any degree of severity inacute phase and experience symptoms for at least three months after discharge).This study aims to answer the following question:1) Which are the effects of a physical activity coaching intervention compared with usualcare in patients post-COVID-19 in the short-, middle- and long-term?
Patients will be invited to participate via phone calls, and those interested will be
scheduled to obtain their written informed consent and undergo a baseline assessment.
Afterwards, they will be randomized into an experimental group and a control group. In
the experimental group, a 12-week/three-month physical activity coaching intervention
will be conducted, while the control group will receive usual care. A post-intervention
assessment will then be carried out, followed by follow-ups at 6 and 12 months after the
baseline assessment.
The assessment will consist of a series of tests and questionnaires to record the
following data: physical activity, functional capacity, muscle strength, health-related
quality of life, symptoms, lung function, sociodemographic, and anthropometric data.
Behavioral: Self-monitoring
pedometer/activity band provided to each participant
Behavioral: Goal setting and review
Goal setting and review (weekly: +15% of the previous week's average daily steps or
walking time, or +1000 steps/day or +10 minutes walking - to be specified)
Behavioral: Education
Educational sessions (face-to-face: providing a manual/explanatory brochure of the
intervention; remote: addressing symptom pathophysiology, symptom management, among other
topics)
Behavioral: Feedback
Daily or weekly feedback for patients (emotional/social support)
Behavioral: Contact
Contact with patients (face-to-face: for assessments; on remote: 1 -messages: for
therapists' daily/weekly feedback or patient reports; 2 - calls: to adjust weekly goals
or address doubts or issues)
Behavioral: Exercise
Exercise based on patient preference, explaining how to identify moderate intensity
(HRmax=64-76%, Borg 3-6) or vigorous intensity (HRmax=77-95%; Borg 7-8) and monitoring
safety parameters (StO2>88%, HRmax<96%, Borg<9)
Behavioral: Report
Daily or weekly reporting for therapists (messages)
Behavioral: Social support
Support meetings (in-person), parallel to educational sessions
Behavioral: Group activities
Group activities (e.g., walking on familiar routes - parks, monumental areas, etc.)
Behavioral: World Health Organization recommendations for being physically active
World Health Organization's recommendations to maintain physical activity levels (i.e.,
150-300 minutes/week of moderate to vigorous intensity physical activity; a weekly
average of 10,000 steps/day or 100-120 minutes walking, which implies maintaining a pace
of 100 steps/minute - corresponding to the average cadence across different age and
gender groups).
Inclusion criteria:
- At least, 18 years of age.
- Having been diagnosed of COVID-19, confirmed by a polymerase chain reaction [PCR]
test or an antigen test, at one of the severity levels during the acute phase of the
illness.
- Presenting a diagnosis of post-COVID-19, persistent COVID, or long COVID, involving
the persistence of symptoms for at least three months after the acute phase of the
illness (i.e., to reduce variability in the diagnosis, it is proposed that symptom
persistence be for at least 12 months).
- Being included in a post-COVID-19 follow-up consultation (or another consultation -
pulmonology, internal medicine - in the event of closure of a specific consultation)
in the region of Madrid, Spain.
- Stable condition of symptoms and comorbidities (i.e., no major change in clinical
status).
Exclusion criteria:
- Presenting significant signs of cognitive decline, cardiovascular, neurological,
and/or musculoskeletal disease that could hinder the performance of assessment tests
and thus limit participation or pose a risk to their health.
- Particularly presenting the following conditions: cognitive disorders such as
sequelae of Alzheimer's disease, senile dementia; comprehension disorders such as
Wernicke's aphasia; cognitive-motor disorders such as hemiparesis/hemiplegia due to
stroke; musculoskeletal disorders such as non-healed fractures, external prostheses
(including prosthetic limbs for amputees); cardiovascular disorders such as unstable
angina, recent acute myocardial infarction, among others.
- Medical history that interferes with the study's objectives or compromises its
conclusions.
- Any health issues that limit life expectancy to less than one year.
- Medical, social, or geographical factor that may endanger the patient.
- Psycho-physical inability to complete assessment tests and questionnaires.
University of Alcalá
Alcalá de Henares 3130616, Madrid 3117732, Spain
María José Yuste Sánchez, PT, Ph.D., Principal Investigator
University of Alcalá, Alcalá de Henares (Madrid), Spain