Clinical trial NCT05543408: Long COVID-19 Syndrome in Primary Care: A Novel Protocol of Exercise Intervention "CON-VIDA Clinical Trial"
Official title: Long COVID-19 Syndrome in Primary Care: A Novel Protocol of Exercise Intervention "CON-VIDA Clinical Trial"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Long COVID
Post-COVID-19 Syndrome
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Lower Limb Strength: 30 s Sit-to-Stand test
timeFrame: Baseline to 8 weeks
measure: Change in Lower Limb Strength: 5 times Sit-to-Stand Test
timeFrame: Baseline to 8 weeks
measure: Change in Handgrip Strength
timeFrame: Baseline to 8 weeks
measure: Chance in upper limbs strength: Arm Curl Biceps
timeFrame: Baseline to 8 weeks
measure: Change in Balance: Flamingo Balance Test
timeFrame: Baseline to 8 weeks
measure: Change in walking speed: Brisk Walking Test
timeFrame: Baseline to 8 weeks
measure: Change in cardiovascular fitness: 6-Minute Walk Test
timeFrame: Baseline to 8 weeks
measure: Change in pulmonary function: Inspiratory and Expiratory Pressures
timeFrame: Baseline to 8 weeks
measure: Change in pulmonary function: Peak flow Test
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Body Composition
timeFrame: Baseline to 8 weeks
measure: Change in Quality of Life-SF-36
timeFrame: Baseline to 8 weeks
measure: Change in The International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline to 8 weeks
measure: Change in Modified Medical Research Council dyspnea scale (mMRC)
timeFrame: Baseline to 8 weeks
measure: Change in Modified Fatigue Impact Scale (MFIS)
timeFrame: Baseline to 8 weeks
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline to 8 weeks
measure: Change in the short form of the DePaul Symptom Questionnaire (DSQ-SF)
timeFrame: Baseline to 8 weeks
measure: Change in the Insommia Severity Index (ISI)
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Lucia Sagarra-Romero
Study officials:
References: