Physical Activity Coaching in Patients with Post-COVID-19

NCT06165978 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2025-02-21

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06165978 on ClinicalTrials.gov