Long COVID-19 Syndrome in Primary Care: A Novel Protocol of Exercise Intervention "CON-VIDA Clinical Trial"

Universidad San Jorge

Status: Active, not recruiting

Conditions: COVID-19; Long COVID; Post-COVID-19 Syndrome

Treatments: Behavioral: EXERCISE

Study type: Interventional

Funder types: Other

Identifiers

NCT05543408

Universidad San Jorge

Details and patient eligibility

About

This is a randomized controlled trial of the efficacy of an individualized, progressive, exercise program (strength, cardiovascular, and breathing exercises) in recovering people from the post-COVID-19 syndrome (i.e., patients who present symptoms >12 weeks once the acute phase of the disease is over).

Full description

This is a randomized controlled trial of the efficacy of an individualized, progressive, exercise program (strength, cardiovascular, and breathing exercises) in recovering people from the post-COVID-19 syndrome (i.e., patients who present symptoms >12 weeks once the acute phase of the disease is over). The primary objective of the study is to evaluate the clinical efficacy and safety of a tailored exercise-based treatment relative to the control arm in improving the subject clinical status in both ambulatory and hospitalized post-COVID-19 syndrome patients. The main novelty of this trial compared to other exercise-based interventions is the development and proof of concept of a progressively, levelled exercise regime for people with physical activity intolerance and fatigue symptoms.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• People over 18 years of age.
• Persistent symptoms of COVID >3 months of duration since infection.
• Have no medical contraindications incompatible with the practice of exercise.
• Do not meet the general 2020 recommendations for physical activity established by the World Health Organization2 (i.e., at least 150-300 minutes of moderate-intensity aerobic physical activity; or at least 75-150 minutes of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week).
• Provide signed informed consent.

Exclusion criteria

• Presence of uncontrolled serious medical illness.
• Presence of any medical, psychological or social problem that could seriously interfere with the patient's participation in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

EXERCISE

Experimental group

Treatment:

Behavioral: EXERCISE

CONTROL

No Intervention group