Physical Activity Coaching in Patients with Post-COVID-19
NCT06165978 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162
Last updated 2025-02-21
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?
Conditions
- Post-COVID-19 Syndrome
Interventions
- BEHAVIORAL
-
Self-monitoring
pedometer/activity band provided to each participant
- BEHAVIORAL
-
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)
- BEHAVIORAL
-
Education
Educational sessions (face-to-face: providing a manual/explanatory brochure of the intervention; remote: addressing symptom pathophysiology, symptom management, among other topics)
- BEHAVIORAL
-
Feedback
Daily or weekly feedback for patients (emotional/social support)
- BEHAVIORAL
-
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)
- BEHAVIORAL
-
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)
- BEHAVIORAL
-
Report
Daily or weekly reporting for therapists (messages)
- BEHAVIORAL
-
Social support
Support meetings (in-person), parallel to educational sessions
- BEHAVIORAL
-
Group activities
Group activities (e.g., walking on familiar routes - parks, monumental areas, etc.)
- BEHAVIORAL
-
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).
Sponsors & Collaborators
-
Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid
collaborator UNKNOWN -
University of Alcala
lead OTHER
Principal Investigators
-
María José Yuste Sánchez, PT, Ph.D. · University of Alcalá, Alcalá de Henares (Madrid), Spain
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-17
- Primary Completion
- 2025-01-31
- Completion
- 2027-12-31
Countries
- Spain
Study Locations
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