Physical Activity Coaching in Patients With Post-COVID-19

Post-COVID-19 Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06165978
• Other study ID #: CEID/2023/3/072
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2023
• Source: University of Alcala
• Contact: Nicola Sante Diciolla, PT, MSc
• Phone: +34695069558
• Email: nicola.diciolla[@]uah.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Post-COVID-19 Syndrome

Intervention

Behavioral:
• Self-monitoring
pedometer/activity band provided to each participant
• Goal setting and review
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)
• Education
Educational sessions (face-to-face: providing a manual/explanatory brochure of the intervention; remote: addressing symptom pathophysiology, symptom management, among other topics)
• Feedback
Daily or weekly feedback for patients (emotional/social support)
• Contact
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
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)
• Report
Daily or weekly reporting for therapists (messages)
• Social support
Support meetings (in-person), parallel to educational sessions
• Group activities
Group activities (e.g., walking on familiar routes - parks, monumental areas, etc.)
• World Health Organization recommendations for being physically active
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).

Locations

Country	Name	City	State
Spain	University of Alcalá	Alcalá de Henares	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
University of Alcala	Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (19)

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Demeyer H, Burtin C, Hornikx M, Camillo CA, Van Remoortel H, Langer D, Janssens W, Troosters T. The Minimal Important Difference in Physical Activity in Patients with COPD. PLoS One. 2016 Apr 28;11(4):e0154587. doi: 10.1371/journal.pone.0154587. eCollection 2016. — View Citation

Demeyer H, Burtin C, Van Remoortel H, Hornikx M, Langer D, Decramer M, Gosselink R, Janssens W, Troosters T. Standardizing the analysis of physical activity in patients with COPD following a pulmonary rehabilitation program. Chest. 2014 Aug;146(2):318-327. doi: 10.1378/chest.13-1968. — View Citation

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Hewlett S, Dures E, Almeida C. Measures of fatigue: Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF MDQ), Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scales (BRAF NRS) for severity, effect, and coping, Chalder Fatigue Questionnaire (CFQ), Checklist Individual Strength (CIS20R and CIS8R), Fatigue Severity Scale (FSS), Functional Assessment Chronic Illness Therapy (Fatigue) (FACIT-F), Multi-Dimensional Assessment of Fatigue (MAF), Multi-Dimensional Fatigue Inventory (MFI), Pediatric Quality Of Life (PedsQL) Multi-Dimensional Fatigue Scale, Profile of Fatigue (ProF), Short Form 36 Vitality Subscale (SF-36 VT), and Visual Analog Scales (VAS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S263-86. doi: 10.1002/acr.20579. No abstract available. — View Citation

Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30. — View Citation

Lista-Paz A, Langer D, Barral-Fernandez M, Quintela-Del-Rio A, Gimeno-Santos E, Arbillaga-Etxarri A, Torres-Castro R, Vilaro Casamitjana J, Varas de la Fuente AB, Serrano Veguillas C, Bravo Cortes P, Martin Cortijo C, Garcia Delgado E, Herrero-Cortina B, Valera JL, Fregonezi GAF, Gonzalez Montanez C, Martin-Valero R, Francin-Gallego M, Sanesteban Hermida Y, Gimenez Moolhuyzen E, Alvarez Rivas J, Rios-Cortes AT, Souto-Camba S, Gonzalez-Doniz L. Maximal Respiratory Pressure Reference Equations in Healthy Adults and Cut-off Points for Defining Respiratory Muscle Weakness. Arch Bronconeumol. 2023 Dec;59(12):813-820. doi: 10.1016/j.arbres.2023.08.016. Epub 2023 Sep 29. English, Spanish. — View Citation

Oliveira A, Rebelo P, Paixao C, Jacome C, Cruz J, Martins V, Simao P, Brooks D, Marques A. Minimal Clinically Important Difference for Quadriceps Muscle Strength in People with COPD following Pulmonary Rehabilitation. COPD. 2021 Feb;18(1):35-44. doi: 10.1080/15412555.2021.1874897. Epub 2021 Feb 3. — View Citation

Rabinovich RA, Louvaris Z, Raste Y, Langer D, Van Remoortel H, Giavedoni S, Burtin C, Regueiro EM, Vogiatzis I, Hopkinson NS, Polkey MI, Wilson FJ, Macnee W, Westerterp KR, Troosters T; PROactive Consortium. Validity of physical activity monitors during daily life in patients with COPD. Eur Respir J. 2013 Nov;42(5):1205-15. doi: 10.1183/09031936.00134312. Epub 2013 Feb 8. — View Citation

Smid DE, Franssen FM, Houben-Wilke S, Vanfleteren LE, Janssen DJ, Wouters EF, Spruit MA. Responsiveness and MCID Estimates for CAT, CCQ, and HADS in Patients With COPD Undergoing Pulmonary Rehabilitation: A Prospective Analysis. J Am Med Dir Assoc. 2017 Jan;18(1):53-58. doi: 10.1016/j.jamda.2016.08.002. Epub 2016 Sep 10. — View Citation

Szentes BL, Kreuter M, Bahmer T, Birring SS, Claussen M, Waelscher J, Leidl R, Schwarzkopf L. Quality of life assessment in interstitial lung diseases:a comparison of the disease-specific K-BILD with the generic EQ-5D-5L. Respir Res. 2018 May 25;19(1):101. doi: 10.1186/s12931-018-0808-x. — View Citation

Taraldsen K, Chastin SF, Riphagen II, Vereijken B, Helbostad JL. Physical activity monitoring by use of accelerometer-based body-worn sensors in older adults: a systematic literature review of current knowledge and applications. Maturitas. 2012 Jan;71(1):13-9. doi: 10.1016/j.maturitas.2011.11.003. Epub 2011 Nov 30. — View Citation

Vaidya T, de Bisschop C, Beaumont M, Ouksel H, Jean V, Dessables F, Chambellan A. Is the 1-minute sit-to-stand test a good tool for the evaluation of the impact of pulmonary rehabilitation? Determination of the minimal important difference in COPD. Int J Chron Obstruct Pulmon Dis. 2016 Oct 19;11:2609-2616. doi: 10.2147/COPD.S115439. eCollection 2016. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

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