NCT06165978

Physical Activity Coaching in Patients with Post-COVID-19

Physical Activity Coaching in Patients with Post-COVID-19. a Randomised Clinical Trial.

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: University of Alcala · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-COVID-19 Syndrome

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2024-04-17
• Primary completion: 2025-01-31
• Completion: 2027-12-31
• First posted: 2023-12-12
• Last updated: 2025-02-21

Locations

1 site across 1 country: Spain