Clinical trial NCT06165978: Physical Activity Coaching in Patients with Post-COVID-19
Official title: Physical Activity Coaching in Patients with Post-COVID-19. a Randomised Clinical Trial.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Post-COVID-19 Syndrome
Keywords: physical activity
physical activity coaching
post-COVID-19
Lead sponsor: University of Alcala
Sponsor class: OTHER
Collaborators: name: Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid
First posted: 2023-12-12
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial aims to compare the effects of a 12-week behavioral physical activity intervention (i.e., physical activity coaching) with usual care (i.e., World Health Organization recommendations for being physically active) in patients with post-COVID-19 (i.e., patients who suffered from COVID-19 at any degree of severity in acute 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 usual care in patients post-COVID-19 in the short-, middle- and long-term?

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Physical activity (PA) patterns (steps/day) from baseline (pre-intervention), at 12 weeks (post-intervention), 6 months and 12 months
timeFrame: Baseline, 12 weeks, 6 months and 12 months
measure: Change in Physical activity (PA) patterns (time spent in light PA per day) from baseline (pre-intervention), at 12 weeks (post-intervention), 6 months and 12 months
timeFrame: Baseline, 12 weeks, 6 months and 12 months
measure: Change in Physical activity (PA) patterns (time spent in moderate-to-vigorous PA per day) from baseline (pre-intervention), at 12 weeks (post-intervention), 6 months and 12 months
timeFrame: Baseline, 12 weeks, 6 months and 12 months
measure: Change in Physical activity (PA) patterns (time in sedentary behaviour -lying or sitting- per day) from baseline (pre-intervention), at 12 weeks (post-intervention), 6 months and 12 months
timeFrame: Baseline, 12 weeks, 6 months and 12 months
measure: Change in functional capacity (six-minute walking test) from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months
timeFrame: Baseline, 12 weeks, 6 months and 12 months
measure: Change in functional capacity (one-minute sit-to-stand test) from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months
timeFrame: Baseline, 12 weeks, 6 months and 12 months
Secondary outcomes:
measure: Change in isometric quadriceps strength from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months
timeFrame: Baseline, 12 weeks, 6 months and 12 months
measure: Change in handgrip force from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months
timeFrame: Baseline, 12 weeks, 6 months and 12 months
measure: Change in maximal inspiratory and expiratory pressures from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months
timeFrame: Baseline, 12 weeks, 6 months and 12 months
measure: Change in health-related quality of life from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months
timeFrame: Baseline, 12 weeks, 6 months and 12 months
measure: Change in dyspnoea symptom from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months
timeFrame: Baseline, 12 weeks, 6 months and 12 months
measure: Change in fatigue symptom from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months
timeFrame: Baseline, 12 weeks, 6 months and 12 months
measure: Change in anxiety and depression symptoms from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months
timeFrame: Baseline, 12 weeks, 6 months and 12 months
measure: Forced expiratory volume in one second (FEV1) assessed using spirometry at baseline (pre-intervention).
timeFrame: Baseline.
measure: Forced expiratory volume in one second percentage predicted (FEV1%predicted) assessed using spirometry at baseline (pre-intervention).
timeFrame: Baseline.
measure: Forced vital capacity (FVC) assessed using spirometry at baseline (pre-intervention).
timeFrame: Baseline.
measure: Forced vital capacity percentage predicted (FVC%predicted) assessed using spirometry at baseline (pre-intervention).
timeFrame: Baseline.
measure: Ratio between Forced expiratory volume in one second and Forced vital capacity (FEV1/FVC) assessed using spirometry at baseline (pre-intervention).
timeFrame: Baseline.
measure: Sociodemographics (age) at baseline (pre-intervention).
timeFrame: Baseline.
measure: Sociodemographics (sex) at baseline (pre-intervention).
timeFrame: Baseline.
measure: Anthropometrics (height) at baseline (pre-intervention).
timeFrame: Baseline.
measure: Anthropometrics (weight) at baseline (pre-intervention).
timeFrame: Baseline.
measure: Anthropometrics (body mass index - BMI) at baseline (pre-intervention).
timeFrame: Baseline.
measure: Proportion of participants with a diagnosed disease according to the International Classification of Diseases (ICD) at baseline (pre-intervention)
timeFrame: Baseline.
measure: Proportion of participants following any pharmacological treatment or plan, as classified by the Anatomical Therapeutic Chemical (ATC) classification system at baseline (pre-intervention).
timeFrame: Baseline.
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: University of Alcalá
state: Madrid
Study officials:
affiliation: University of Alcalá, Alcalá de Henares (Madrid), Spain
name: María José Yuste Sánchez, PT, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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