Physical Activity Coaching in Patients with Post-COVID-19
NCT ID: NCT06165978
Last Updated: 2025-02-21
Study Results
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Basic Information
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SUSPENDED
NA
162 participants
INTERVENTIONAL
2024-04-17
2027-12-31
Brief Summary
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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?
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Physical activity coaching - Experimental group
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).
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).
Usual care - Control group
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).
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid
UNKNOWN
University of Alcala
OTHER
Responsible Party
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María José Yuste Sánchez
Associate Professor, Co-founder, and Co-Principal Investigator of the Physiotherapy in Women's Health Research Group - FPSM
Principal Investigators
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María José Yuste Sánchez, PT, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Alcalá, Alcalá de Henares (Madrid), Spain
Locations
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University of Alcalá
Alcalá de Henares, Madrid, Spain
Countries
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References
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Other Identifiers
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CEID/2023/3/072
Identifier Type: -
Identifier Source: org_study_id
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