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

NCT ID: NCT05543408

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-03
• Study Completion Date: 2022-10-31

Brief Summary

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).

Detailed 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.

Conditions

COVID-19; Long COVID; Post-COVID-19 Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EXERCISE

Group Type: EXPERIMENTAL

EXERCISE

Intervention Type: BEHAVIORAL

individualized, progressive, exercise program

CONTROL

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EXERCISE

individualized, progressive, exercise program

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad San Jorge

OTHER

Sponsor Role: lead

Responsible Party

Lucia Sagarra

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lucia Sagarra-Romero

Zaragoza, , Spain

Countries

Spain

Other Identifiers

Universidad San Jorge

Identifier Type: -

Identifier Source: org_study_id