Physical Activity Coaching in Patients with Post-COVID-19. a Randomised Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Enrollment
- 162
- Locations
- 2
- Primary Endpoint
- Change in Physical activity (PA) patterns (steps/day) from baseline (pre-intervention), at 12 weeks (post-intervention), 6 months and 12 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in Physical activity (PA) patterns (steps/day) from baseline (pre-intervention), at 12 weeks (post-intervention), 6 months and 12 months
Time Frame: Baseline, 12 weeks, 6 months and 12 months
Patients will wear an inertial measurement unit (a three-axial accelerometer and three-axial gyroscope) for one week. A valid assessment will require a minimum of four days with at least 8 hours of wearing time, excluding weekends. The minute-by-minute output, including the number of steps and metabolic equivalents of task (METs), will be exported. Using a statistical package and an appropriate algorithm, we will extract: the total daily step count (steps/day).
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
Time Frame: Baseline, 12 weeks, 6 months and 12 months
Patients will wear an inertial measurement unit (a three-axial accelerometer and three-axial gyroscope) for one week. A valid assessment will require a minimum of four days with at least 8 hours of wearing time, excluding weekends. The minute-by-minute output, including the number of steps and metabolic equivalents of task (METs), will be exported. Using a statistical package and an appropriate algorithm, we will extract: the total time spent in light PA per day (hours and minutes per day)
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
Time Frame: Baseline, 12 weeks, 6 months and 12 months
Patients will wear an inertial measurement unit (a three-axial accelerometer and three-axial gyroscope) for one week. A valid assessment will require a minimum of four days with at least 8 hours of wearing time, excluding weekends. The minute-by-minute output, including the number of steps and metabolic equivalents of task (METs), will be exported. Using a statistical package and an appropriate algorithm, we will extract: the total time in sedentary behaviour -lying or sitting- per day (hours and minutes per day)
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
Time Frame: Baseline, 12 weeks, 6 months and 12 months
Patients will wear an inertial measurement unit (a three-axial accelerometer and three-axial gyroscope) for one week. A valid assessment will require a minimum of four days with at least 8 hours of wearing time, excluding weekends. The minute-by-minute output, including the number of steps and metabolic equivalents of task (METs), will be exported. Using a statistical package and an appropriate algorithm, we will extract: the total time spent in moderate-to-vigorous PA per day (hours and minutes per day)
Change in functional capacity (six-minute walking test) from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months
Time Frame: Baseline, 12 weeks, 6 months and 12 months
Six-minute walking test/distance \[6MWT/6MWD\]. Patients will be asked to walk as far as possible in six minutes along a flat 30m corridor. Standardised instructions and encouragement will be given during the test, following European Respiratory Society/American Thoracic Society (ERS/ATS) statement.
Change in functional capacity (one-minute sit-to-stand test) from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months
Time Frame: Baseline, 12 weeks, 6 months and 12 months
One-minute sit-to-stand \[1minSTS\]. Patients will sit and stand from a chair, without the aid of the upper limbs, many times as they can in a 1-min bout. Afterwards, the results will be compared to age- and sex-matched reference values.
Secondary Outcomes
- Change in dyspnoea symptom from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months(Baseline, 12 weeks, 6 months and 12 months)
- Change in isometric quadriceps strength from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months(Baseline, 12 weeks, 6 months and 12 months)
- Change in maximal inspiratory and expiratory pressures from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months(Baseline, 12 weeks, 6 months and 12 months)
- Forced expiratory volume in one second (FEV1) assessed using spirometry at baseline (pre-intervention).(Baseline.)
- Change in handgrip force from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months(Baseline, 12 weeks, 6 months and 12 months)
- Change in health-related quality of life from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months(Baseline, 12 weeks, 6 months and 12 months)
- Forced expiratory volume in one second percentage predicted (FEV1%predicted) assessed using spirometry at baseline (pre-intervention).(Baseline.)
- Sociodemographics (age) at baseline (pre-intervention).(Baseline.)
- Anthropometrics (height) at baseline (pre-intervention).(Baseline.)
- Proportion of participants with a diagnosed disease according to the International Classification of Diseases (ICD) at baseline (pre-intervention)(Baseline.)
- Sociodemographics (sex) at baseline (pre-intervention).(Baseline.)
- Anthropometrics (body mass index - BMI) at baseline (pre-intervention).(Baseline.)
- Change in fatigue symptom from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months(Baseline, 12 weeks, 6 months and 12 months)
- Change in anxiety and depression symptoms from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months(Baseline, 12 weeks, 6 months and 12 months)
- Forced vital capacity (FVC) assessed using spirometry at baseline (pre-intervention).(Baseline.)
- Ratio between Forced expiratory volume in one second and Forced vital capacity (FEV1/FVC) assessed using spirometry at baseline (pre-intervention).(Baseline.)
- Anthropometrics (weight) at baseline (pre-intervention).(Baseline.)
- Forced vital capacity percentage predicted (FVC%predicted) assessed using spirometry at baseline (pre-intervention).(Baseline.)
- Proportion of participants following any pharmacological treatment or plan, as classified by the Anatomical Therapeutic Chemical (ATC) classification system at baseline (pre-intervention).(Baseline.)
Investigators
María José Yuste Sánchez
Associate Professor, Co-founder, and Co-Principal Investigator of the Physiotherapy in Women's Health Research Group - FPSM
University of Alcala