Physical Activity Coaching in Patients with Post-COVID-19

Not Applicable

Suspended

• Conditions: Post-COVID-19 Syndrome
• Interventions: Behavioral: Self-monitoring; Behavioral: World Health Organization recommendations for being physically active; Behavioral: Goal setting and review; Behavioral: Education; Behavioral: Feedback; Behavioral: Contact; Behavioral: Exercise; Behavioral: Report; Behavioral: Social support; Behavioral: Group activities

• Registration Number: NCT06165978
• Lead Sponsor: University of Alcala

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 Timeline

• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-11
• Study First Posted: 2023-12-12
• Study Start: 2024-04-17
• Primary Completion: 2025-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical activity coaching - Experimental group	Goal setting and review	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).
Physical activity coaching - Experimental group	Self-monitoring	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).
Physical activity coaching - Experimental group	Exercise	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).
Physical activity coaching - Experimental group	Report	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).
Usual care - Control group	World Health Organization recommendations for being physically active	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).
Physical activity coaching - Experimental group	Feedback	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).
Physical activity coaching - Experimental group	Contact	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).
Physical activity coaching - Experimental group	Social support	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).
Physical activity coaching - Experimental group	Group activities	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).
Physical activity coaching - Experimental group	Education	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).
Physical activity coaching - Experimental group	World Health Organization recommendations for being physically active	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).

Primary Outcome Measures

Name	Time	Method
Change in Physical activity (PA) patterns (steps/day) from baseline (pre-intervention), at 12 weeks (post-intervention), 6 months and 12 months	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	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	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	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	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	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 Outcome Measures

Name	Time	Method
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	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.
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	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.
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	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.
Forced expiratory volume in one second (FEV1) assessed using spirometry at baseline (pre-intervention).	Baseline.	Forced expiratory volume in the first second (FEV1 in milliliters)
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	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.
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	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.
Forced expiratory volume in one second percentage predicted (FEV1%predicted) assessed using spirometry at baseline (pre-intervention).	Baseline.	Forced expiratory volume in the first second (FEV1) as percentage predicted
Sociodemographics (age) at baseline (pre-intervention).	Baseline.	Sociodemographics (age in years).
Anthropometrics (height) at baseline (pre-intervention).	Baseline.	Anthropometrics (height in meters).
Proportion of participants with a diagnosed disease according to the International Classification of Diseases (ICD) at baseline (pre-intervention)	Baseline.	Absolute and relative frequencies of any diagnosed disease will be reported using the International Classification of Diseases (ICD).
Sociodemographics (sex) at baseline (pre-intervention).	Baseline.	Sociodemographics (sex, assessed as male/female).
Anthropometrics (body mass index - BMI) at baseline (pre-intervention).	Baseline.	Weight and height will be combined to report BMI in kilograms/meters\^2 (kg/m\^2).
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	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.
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	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.
Forced vital capacity (FVC) assessed using spirometry at baseline (pre-intervention).	Baseline.	Forced vital capacity (FVC in milliliters)
Ratio between Forced expiratory volume in one second and Forced vital capacity (FEV1/FVC) assessed using spirometry at baseline (pre-intervention).	Baseline.	Ratio between Forced expiratory volume in the first second and Forced vital capacity (FEV1/FVC, percentage)
Anthropometrics (weight) at baseline (pre-intervention).	Baseline.	Anthropometrics (weight in kilograms).
Forced vital capacity percentage predicted (FVC%predicted) assessed using spirometry at baseline (pre-intervention).	Baseline.	Forced vital capacity (FVC) as percentage predicted
Proportion of participants following any pharmacological treatment or plan, as classified by the Anatomical Therapeutic Chemical (ATC) classification system at baseline (pre-intervention).	Baseline.	Absolute and relative frequencies of any pharmacological treatment will be reported in accordance with the Anatomical Therapeutic Chemical (ATC) classification system.

Trial Locations

Locations (1)

University of Alcalá; 🇪🇸 Alcalá de Henares, Madrid, Spain