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?
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
162
pedometer/activity band provided to each participant
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)
Educational sessions (face-to-face: providing a manual/explanatory brochure of the intervention; remote: addressing symptom pathophysiology, symptom management, among other topics)
University of Alcalá
Alcalá de Henares, Madrid, Spain
Change in Physical activity (PA) patterns (steps/day) from baseline (pre-intervention), at 12 weeks (post-intervention), 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).
Time frame: Baseline, 12 weeks, 6 months and 12 months
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
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)
Time frame: Baseline, 12 weeks, 6 months and 12 months
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
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)
Time frame: Baseline, 12 weeks, 6 months and 12 months
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Daily or weekly feedback for patients (emotional/social support)
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)
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)
Daily or weekly reporting for therapists (messages)
Support meetings (in-person), parallel to educational sessions
Group activities (e.g., walking on familiar routes - parks, monumental areas, etc.)
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).
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)
Time frame: Baseline, 12 weeks, 6 months and 12 months
Change in functional capacity (six-minute walking test) from baseline (pre-intervention) at 12 weeks (post-intervention), 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.
Time frame: Baseline, 12 weeks, 6 months and 12 months
Change in functional capacity (one-minute sit-to-stand test) from baseline (pre-intervention) at 12 weeks (post-intervention), 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.
Time frame: 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
Isometric quadriceps strength (dynamometer). A hand-held dynamometer will be used to assess isometric strength of the dominant leg. Participants will be seated at the edge of a treatment table, positioned at 60º of knee flexion, and with arms across the chest. The dynamometer will be positioned two fingers width above the lateral malleolus on the anterior aspect of the tibia. Four warm-ups will be allowed, on each at 25, 50, 75, and 100% of perceived effort, gradually building up to a maximal effort over 1 to 2 seconds. The tester will perform two make tests with the subject exerting 100% effort for 3 seconds. Average peak force of the two trials will be used to determine quadriceps muscle performance. The make test will entail the examiner giving appropriate resistance to the muscle force in order to ensure isometric conditions.
Time frame: Baseline, 12 weeks, 6 months and 12 months
Change in handgrip force from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months
Handgrip force (dynamometer). A hand-held dynamometer will be used to measure isometric strength of the grip. Participants will be seated on a straight back chair with both feet flat on the floor. Arm positioning will be demonstrated by the examiner: the tested arm (dominant) will have the elbow bended to 90º, the forearm and wrist in neutral position, and the fingers flexed as needed for a maximal contraction, while the not-tested arm will assume an adducted and neutrally rotated shoulder position. Subjects will be instructed to breathe in through their nose and blow out through pursed lips while making a maximum grip effort. At this time, a verbal encouragement will be given by the examiner (e.g., "Squeeze! Harder! Harder! Relax!"). Rest will be allowed between each grip assessment, no longer than four minutes. The average score among three trials will be recorded.
Time frame: 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
Maximal respiratory pressures (PImax, PEmax) will be measured using a portable digital manometer; and assessed according to the European Respiratory Society/American Thoracic Society (ERS/ATS) recommendations \[31\] and following the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) protocol. Then, the highest value of 3 attempts will be selected to obtain a reliable average, excluding pressure peaks lower than one second. Participants will be asked to sit with their neck and chest in an upright position and their feet flat on the floor. The results will be read using the current reference values in Spanish population provided by Lista-Paz et al. 2023.
Time frame: 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
Health-related quality of life \[EuroQoL-five dimensions-five levels (EQ-5D-5L) questionnaire). The EQ-5D-5L consists of two parts: the descriptive system and a visual analogue scale (VAS). The descriptive system addresses five different dimensions (mobility, self-care, usual activities. pain/discomfort, and anxiety/depression), each with a five-point Likert-scale; the answering pattern can be transferred to a utility between 0 and 1 (the higher the better) by distinct (nation-specific) scoring algorithms. On the other hand, the VAS allows valuing current health on a 0-100 mm scale, with higher values indicating better health.
Time frame: Baseline, 12 weeks, 6 months and 12 months
Change in dyspnoea symptom from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months
Dyspnea - modified Medical Research Council (mMRC) scale. The mMRC dyspnea scale consists of five grades of increasing severity. A higher score indicates a greater impact of dyspnea on activities of daily life.
Time frame: Baseline, 12 weeks, 6 months and 12 months
Change in fatigue symptom from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months
Fatigue - Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale. The FACIT-F scale consists of many items to produce a global score, and each item can be scored from 0 to 4 (from "not at all" to "very much"). It covers different aspects of fatigue (physical, functional, emotional, and social consequences) with regard to the previous seven days. A higher score reflects less fatigue.
Time frame: 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
Anxiety and depression-The Hospital Anxiety and Depression Scale (HADS). The HADS consists of two subscales (HADS-A, for anxiety disorders, and HADS-D, for depression) both containing seven intermingled items. A higher score implies a more severe case.
Time frame: Baseline, 12 weeks, 6 months and 12 months
Forced expiratory volume in one second (FEV1) assessed using spirometry at baseline (pre-intervention).
Forced expiratory volume in the first second (FEV1 in milliliters)
Time frame: Baseline.
Forced expiratory volume in one second percentage predicted (FEV1%predicted) assessed using spirometry at baseline (pre-intervention).
Forced expiratory volume in the first second (FEV1) as percentage predicted
Time frame: Baseline.
Forced vital capacity (FVC) assessed using spirometry at baseline (pre-intervention).
Forced vital capacity (FVC in milliliters)
Time frame: Baseline.
Forced vital capacity percentage predicted (FVC%predicted) assessed using spirometry at baseline (pre-intervention).
Forced vital capacity (FVC) as percentage predicted
Time frame: Baseline.
Ratio between Forced expiratory volume in one second and Forced vital capacity (FEV1/FVC) assessed using spirometry at baseline (pre-intervention).
Ratio between Forced expiratory volume in the first second and Forced vital capacity (FEV1/FVC, percentage)
Time frame: Baseline.
Sociodemographics (age) at baseline (pre-intervention).
Sociodemographics (age in years).
Time frame: Baseline.
Sociodemographics (sex) at baseline (pre-intervention).
Sociodemographics (sex, assessed as male/female).
Time frame: Baseline.
Anthropometrics (height) at baseline (pre-intervention).
Anthropometrics (height in meters).
Time frame: Baseline.
Anthropometrics (weight) at baseline (pre-intervention).
Anthropometrics (weight in kilograms).
Time frame: Baseline.
Anthropometrics (body mass index - BMI) at baseline (pre-intervention).
Weight and height will be combined to report BMI in kilograms/meters\^2 (kg/m\^2).
Time frame: Baseline.
Proportion of participants with a diagnosed disease according to the International Classification of Diseases (ICD) at baseline (pre-intervention)
Absolute and relative frequencies of any diagnosed disease will be reported using the International Classification of Diseases (ICD).
Time frame: Baseline.
Proportion of participants following any pharmacological treatment or plan, as classified by the Anatomical Therapeutic Chemical (ATC) classification system at baseline (pre-intervention).
Absolute and relative frequencies of any pharmacological treatment will be reported in accordance with the Anatomical Therapeutic Chemical (ATC) classification system.
Time frame: Baseline.