Physical Activity Coaching in Patients with Post-COVID-19. a Randomised Clinical Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post-COVID-19 Syndrome
- Sponsor
- University of Alcala
- Enrollment
- 162
- Locations
- 1
- Primary Endpoint
- Change in Physical activity (PA) patterns (steps/day) from baseline (pre-intervention), at 12 weeks (post-intervention), 6 months and 12 months
- Status
- Suspended
- Last Updated
- last year
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:
- 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.
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
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
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.)