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

NCT05543408 | Unknown

• 1 other identifier: Universidad San Jorge
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (9)

• Change in Lower Limb Strength: 30 s Sit-to-Stand test

  The test starts with the participant seated on a chair (43.2 cm), arms crossed at the wrists and held against the chest. From this position, participants will conduct as much as sit-to-stand repetitions, as fast as possible, during 30 s

  Baseline to 8 weeks

• Change in Lower Limb Strength: 5 times Sit-to-Stand Test

  Participants will have to sit and stand 5 times (as quickly as possible) from a chair (43.2 cm), arms crossed at the wrists and held against the chest. Time will be register.

  Baseline to 8 weeks

• Change in Handgrip Strength

  Start by holding the instrument in the testing hand. Squeeze the dynamometer handle as hard as possible to obtain peak force values.

  Baseline to 8 weeks

• Chance in upper limbs strength: Arm Curl Biceps

  The subject sits on chair, holding the weight in the hand using suitcase grip, with the arm in a vertically downward position beside the chair. Curl the arm up through a full range of motion, gradually returns to the starting position. The arm must be fully bent and then fully straightened at the elbow. The aim of this test is to do as many arm curl as possible in 30 seconds.

  Baseline to 8 weeks

• Change in Balance: Flamingo Balance Test

  Number of seconds keeping balance with one foot on the floor and the other resting on the opposite ankle (maximum 60 s)

  Baseline to 8 weeks

• Change in walking speed: Brisk Walking Test

  Number of seconds required to walk 30 m.

  Baseline to 8 weeks

• Change in cardiovascular fitness: 6-Minute Walk Test

  Number of meters that can be walked in 6 min around 30 m track.

  Baseline to 8 weeks

• Change in pulmonary function: Inspiratory and Expiratory Pressures

  The maximal inspiratory pressure (MIP) and Maximum Expiratory Pressure (MEP) reflects the respiratory muscles ability to generate force during a short quasi-static contraction. MIP and MEP measurements are conducted with a manometer that measures mouth pressure and these depend on the motivation and co-ordination of the patient. Procedures: * MIP: from tidal breathing the patient slowly exhales as deeply as possible. During expiration the measurement is started manually. The shutter will be set as soon as the patient starts to breathe in. Now the patient is asked to inspire as fast and as powerful as possible against the shutter. The maximal inspiratory pressure will be reached after about 0.5-1 s. * MEP: from tidal breathing the patient slowly breathes in as deeply as possible. The shutter will be closed with expiration onset. Now the patient is asked to expire as fast and as powerful as possible against the shutter.

  Baseline to 8 weeks

• Change in pulmonary function: Peak flow Test

  Peak expiratory flow measurement (peak flow) is a simple measure of the maximal flow rate that can be achieved during forceful expiration following full inspiration. First, the patient should reset the meter by sliding the marker all the way to zero on the scale. While sitting or standing up straight, the patient should take in a full, deep breath. The mouthpiece is then placed in the patient's mouth followed by a single, fast, forceful expiration. The marker will slide outward on the numbered scale, indicating the peak expiratory flow rate for that attempt.

  Baseline to 8 weeks

Secondary Outcomes (8)

• Body Composition

  Baseline to 8 weeks

• Change in Quality of Life-SF-36

  Baseline to 8 weeks

• Change in The International Physical Activity Questionnaire (IPAQ)

  Baseline to 8 weeks

• Change in Modified Medical Research Council dyspnea scale (mMRC)

  Baseline to 8 weeks

• Change in Modified Fatigue Impact Scale (MFIS)

  Baseline to 8 weeks

Study Arms (2)

EXERCISE

EXPERIMENTAL

Behavioral: EXERCISE

CONTROL

NO INTERVENTION

Interventions

EXERCISE BEHAVIORAL

individualized, progressive, exercise program

EXERCISE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad San Jorge: lead

Study Sites (1)

Lucia Sagarra-Romero

Zaragoza, 50830, Spain

Location

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 16, 2022
• Study Start: May 3, 2022
• Primary Completion: August 2, 2022
• Study Completion: October 31, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Locations

ES (1)