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

Primary Purpose

COVID-19, Long COVID, Post-COVID-19 Syndrome

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
EXERCISE
Sponsored by
Universidad San Jorge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Lucia Sagarra-Romero

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EXERCISE

CONTROL

Arm Description

Outcomes

Primary Outcome Measures

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
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.
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.
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.
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)
Change in walking speed: Brisk Walking Test
Number of seconds required to walk 30 m.
Change in cardiovascular fitness: 6-Minute Walk Test
Number of meters that can be walked in 6 min around 30 m track.
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.
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.

Secondary Outcome Measures

Body Composition
Bio-Electrical Impedance Analysis (BIA) with 200 kg maximum capacity and 50 g error margin (TANITA BC-418MA, Tanita Corp., Tokyo, Japan).The meassurement includes: body weight (kg) body fat mass, the percentage of body fat (BF%) and the fat-free mass (FFM). Body mass index (BMI) will be calculated dividing weight (kg) by squared height (m2).
Change in Quality of Life-SF-36
The SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Change in The International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.
Change in Modified Medical Research Council dyspnea scale (mMRC)
The mMRC Dyspnea Scale is used to assess the degree of baseline functional disability due to dyspnea in patients with respiratory problems. The mMRC breathlessness scale ranges from grade 0 to 4 (low to high).
Change in Modified Fatigue Impact Scale (MFIS)
The MFIS measures the impact fatigue takes on a patient's daily life. It consists of 21 items divided into 3 subdivision containing 9 physical items , 10 cognitive items and 2 psychosocial. All the items are rated from 0-4 . The sum of all the questions are calculated where 84 is the highest score. Highest the score means higher the impact of fatigue in daily living.
Change in Hospital Anxiety and Depression Scale (HADS)
HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression.
Change in the short form of the DePaul Symptom Questionnaire (DSQ-SF)
The short for of the DSQ-SF is a self-report measure of demographic characteristics, myalgic encephalomyelitis and chronic fatigue syndrome symptomatology, and medical, occupational, and social history.
Change in the Insommia Severity Index (ISI)
The ISI is composed of seven items that evaluate the severity of sleep disturbance during the past 2 week * The first three items assess the severity of difficulties with falling sleep, maintaining sleep, and early morning awakening. The last four items capture satisfaction with the current sleep patte, interference with daily functioning, noticeability of impairment, and degree of distress caused by the sleep problem. The scores of each of the seven items range from 0 to 4 (0 = none; 4 = very severe), and a total score can be calculated by summing the seven items, giving a range from 0 to 28, with higher scores indicating greater insomnia severity. Total scores are interpreted as 0-7, absence of insomnia; 8-14, sub-threshold insomnia; 15-21, moderate insomnia; 22-28, severe insomnia.

Full Information

First Posted
September 15, 2022
Last Updated
September 19, 2022
Sponsor
Universidad San Jorge
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1. Study Identification

Unique Protocol Identification Number
NCT05543408
Brief Title
Long COVID-19 Syndrome in Primary Care: A Novel Protocol of Exercise Intervention "CON-VIDA Clinical Trial"
Acronym
CON-VIDA
Official Title
Long COVID-19 Syndrome in Primary Care: A Novel Protocol of Exercise Intervention "CON-VIDA Clinical Trial"
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
August 2, 2022 (Actual)
Study Completion Date
October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad San Jorge

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Long COVID, Post-COVID-19 Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EXERCISE
Arm Type
Experimental
Arm Title
CONTROL
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
EXERCISE
Intervention Description
individualized, progressive, exercise program
Primary Outcome Measure Information:
Title
Change in Lower Limb Strength: 30 s Sit-to-Stand test
Description
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
Time Frame
Baseline to 8 weeks
Title
Change in Lower Limb Strength: 5 times Sit-to-Stand Test
Description
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.
Time Frame
Baseline to 8 weeks
Title
Change in Handgrip Strength
Description
Start by holding the instrument in the testing hand. Squeeze the dynamometer handle as hard as possible to obtain peak force values.
Time Frame
Baseline to 8 weeks
Title
Chance in upper limbs strength: Arm Curl Biceps
Description
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.
Time Frame
Baseline to 8 weeks
Title
Change in Balance: Flamingo Balance Test
Description
Number of seconds keeping balance with one foot on the floor and the other resting on the opposite ankle (maximum 60 s)
Time Frame
Baseline to 8 weeks
Title
Change in walking speed: Brisk Walking Test
Description
Number of seconds required to walk 30 m.
Time Frame
Baseline to 8 weeks
Title
Change in cardiovascular fitness: 6-Minute Walk Test
Description
Number of meters that can be walked in 6 min around 30 m track.
Time Frame
Baseline to 8 weeks
Title
Change in pulmonary function: Inspiratory and Expiratory Pressures
Description
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.
Time Frame
Baseline to 8 weeks
Title
Change in pulmonary function: Peak flow Test
Description
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.
Time Frame
Baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Body Composition
Description
Bio-Electrical Impedance Analysis (BIA) with 200 kg maximum capacity and 50 g error margin (TANITA BC-418MA, Tanita Corp., Tokyo, Japan).The meassurement includes: body weight (kg) body fat mass, the percentage of body fat (BF%) and the fat-free mass (FFM). Body mass index (BMI) will be calculated dividing weight (kg) by squared height (m2).
Time Frame
Baseline to 8 weeks
Title
Change in Quality of Life-SF-36
Description
The SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Time Frame
Baseline to 8 weeks
Title
Change in The International Physical Activity Questionnaire (IPAQ)
Description
The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.
Time Frame
Baseline to 8 weeks
Title
Change in Modified Medical Research Council dyspnea scale (mMRC)
Description
The mMRC Dyspnea Scale is used to assess the degree of baseline functional disability due to dyspnea in patients with respiratory problems. The mMRC breathlessness scale ranges from grade 0 to 4 (low to high).
Time Frame
Baseline to 8 weeks
Title
Change in Modified Fatigue Impact Scale (MFIS)
Description
The MFIS measures the impact fatigue takes on a patient's daily life. It consists of 21 items divided into 3 subdivision containing 9 physical items , 10 cognitive items and 2 psychosocial. All the items are rated from 0-4 . The sum of all the questions are calculated where 84 is the highest score. Highest the score means higher the impact of fatigue in daily living.
Time Frame
Baseline to 8 weeks
Title
Change in Hospital Anxiety and Depression Scale (HADS)
Description
HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression.
Time Frame
Baseline to 8 weeks
Title
Change in the short form of the DePaul Symptom Questionnaire (DSQ-SF)
Description
The short for of the DSQ-SF is a self-report measure of demographic characteristics, myalgic encephalomyelitis and chronic fatigue syndrome symptomatology, and medical, occupational, and social history.
Time Frame
Baseline to 8 weeks
Title
Change in the Insommia Severity Index (ISI)
Description
The ISI is composed of seven items that evaluate the severity of sleep disturbance during the past 2 week * The first three items assess the severity of difficulties with falling sleep, maintaining sleep, and early morning awakening. The last four items capture satisfaction with the current sleep patte, interference with daily functioning, noticeability of impairment, and degree of distress caused by the sleep problem. The scores of each of the seven items range from 0 to 4 (0 = none; 4 = very severe), and a total score can be calculated by summing the seven items, giving a range from 0 to 28, with higher scores indicating greater insomnia severity. Total scores are interpreted as 0-7, absence of insomnia; 8-14, sub-threshold insomnia; 15-21, moderate insomnia; 22-28, severe insomnia.
Time Frame
Baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Lucia Sagarra-Romero
City
Zaragoza
ZIP/Postal Code
50830
Country
Spain

12. IPD Sharing Statement

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

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