Physical Activity Coaching in Patients With Post-COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physical Activity Coaching in Patients With Post-COVID-19. A Randomised Clinical Trial.

Conditions
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Post-COVID-19 Syndrome

Intervention / Treatment
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* Behavioral: Self-monitoring
* Behavioral: Goal setting and review
* Behavioral: Education
* Behavioral: Feedback
* Behavioral: Contact
* Behavioral: Exercise
* Behavioral: Report
* Behavioral: Social support
* Behavioral: Group activities
* Behavioral: World Health Organization recommendations for being physically active


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity coaching - Experimental group<br>The experimental group intervention consists of a 12-week physical activity coaching program informed by the literature (CRD42021253066). The intervention is conducted at participants' home or within the community, delivered remotely (mostly) and face-to-face, and encompasses several behaviour change components (mandatory: self-monitoring, goal setting/review, education, feedback, contact; optional: exercise, reports, support meeting, group activities). | Behavioral: Self-monitoring<br>* pedometer/activity band provided to each participant<br>Behavioral: Goal setting and review<br>* 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)<br>Behavioral: Education<br>* Educational sessions (face-to-face: providing a manual/explanatory brochure of the intervention; remote: addressing symptom pathophysiology, symptom management, among other topics)<br>Behavioral: Feedback<br>* Daily or weekly feedback for patients (emotional/social support)<br>Behavioral: Contact<br>* 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)<br>Behavioral: Exercise<br>* 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)<br>Behavioral: Report<br>* Daily or weekly reporting for therapists (messages)<br>Behavioral: Social support<br>* Support meetings (in-person), parallel to educational sessions<br>Behavioral: Group activities<br>* Group activities (e.g., walking on familiar routes - parks, monumental areas, etc.)<br>Behavioral: World Health Organization recommendations for being physically active<br>* 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).<br>|
| Other: Usual care - Control group<br>The control group intervention runs parallel to the experimental group for 12 weeks, conducted at participants' home or within the community, and consists of usual management (i.e., World Health Organization's recommendations for being physically active). | Behavioral: World Health Organization recommendations for being physically active<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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) | 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) | 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 | 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) | 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. | 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. | Baseline, 12 weeks, 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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) | 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 | Baseline. | 
| Forced vital capacity (FVC) assessed using spirometry at baseline (pre-intervention). | Forced vital capacity (FVC in milliliters) | Baseline. | 
| Forced vital capacity percentage predicted (FVC%predicted) assessed using spirometry at baseline (pre-intervention). | Forced vital capacity (FVC) as percentage predicted | 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) | Baseline. | 
| Sociodemographics (age) at baseline (pre-intervention). | Sociodemographics (age in years). | Baseline. | 
| Sociodemographics (sex) at baseline (pre-intervention). | Sociodemographics (sex, assessed as male/female). | Baseline. | 
| Anthropometrics (height) at baseline (pre-intervention). | Anthropometrics (height in meters). | Baseline. | 
| Anthropometrics (weight) at baseline (pre-intervention). | Anthropometrics (weight in kilograms). | 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). | 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). | 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. | Baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, physical activity coaching, post-COVID-19