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There are 2 clinical trials
After a hospitalization in Intensive Care Unit (ICU), approximately 50% of patients usually have a ICU-Weakness, i.e. nerves and muscles injury secondary to immobilization and to treatments which had to be used. This disease is expected to be similar or even higher in patients suffering from COVID-19 and hospitalized in ICU due to the average length of hospitalization of several weeks in this population. This condition will delay the return-to-walk of these patients, their discharge from hospitalization and may deteriorate their autonomy in daily life activities. Virtual Reality (VR) environments are already used and have proven their worth for the assessment and rehabilitation of patients with neurological diseases. It therefore seems appropriate to offer the use of virtual environments for this type of population. VR represents a unique opportunity for the rehabilitation care of these patients, and in particular those who have been reached by COVID-19, due to the possible mismatch between the amount of motor rehabilitation to be provided and the fatigability and breathlessness at the slightest effort which seem particularly intense in this population. The main objective of our project is to improve and to accelerate gait recovery in patients hospitalized in Physical and Rehabilitation Medicine after discharge from Resuscitation or Continuous Care Unit and in patients hospitalized in ICU and presenting ICU-weakness secondary to resuscitation, notably due to COVID-19 infection, thanks to the use of Virtual Reality tools. The VR tool will consist of virtual environments presented using a Virtual Reality headset where an avatar (double) of the patient hospitalized in Physical and Rehabilitation Medicine or in ICU will be represented, who will perform different motor tasks involving their lower limbs (ex: walking, or kicking a ball) in several different virtual environments (settings). The patient will be asked to observe actions, then to imagine carrying out their actions which will be performed by the avatar in the virtual environment, then they will be able to control the actions of the avatar using their legs thanks to sensors, then feel walking sensations through the use of haptic devices.
Description: Number of meters taken during the 6-minute test the day after the last session.
Measure: 6-minute test Time: Day 10Description: Gait assessment before the start of the first session, the day after the last session and 1 month from inclusion: 10-meter test (time in seconds)
Measure: Time for 10-meter test Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusionDescription: Gait assessment before the start of the first session, the day after the last session and 1 month from inclusion: 6-minute walk test (need for breaks, scale de Borg, existence of desaturation)
Measure: 6-minute walk test Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusionDescription: Gait assessment before the start of the first session, the day after the last session and 1 month from inclusion: recovery time for walking over 10 meters without human or technical assistance
Measure: Recovery time Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusionDescription: Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: normal or deficient posture balance in sitting and standing
Measure: Normal or deficient posture balance in sitting and standing Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusionDescription: Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: Berg Balance Scale. Berg's balance scale includes 14 tests that assess static balance and dynamic balance. Each test is rated from 0 (needs help) to 4 (can do on him/her own). Total score is on 56 points.
Measure: Berg Balance Scale Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusionDescription: Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: Timed Up and Go test (time in seconds)
Measure: Timed Up and Go test Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusionDescription: Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: test of the 10 chair lifts (duration in seconds, existence of a desaturation, Borg scale)
Measure: Duration for the test of the 10 chair lifts Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusionDescription: Strength assessment before the start of the first session, the day after the last session and within 1 month of inclusion: MRC testing of the lower limbs. The Medical Research Council's scale (MRC scale) is an assessment of muscle power, rated form 0 (no contraction) to 5 (normal power).
Measure: MRC scale Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusionDescription: Assessment of autonomy before the start of the first session, the day after the last session and within 1 month of inclusion: Functional Independence Measure. The Functional Independence Measure (FIM) is an 18-item instrument measuring a person's level of disability in terms of burden of care. Each item is rated from 1 (requiring total assistance) to 7 (completely independent). Three independent FIM scores can be generated by summing item scores: a total score (FIM total: 18 items), a motor score (FIM motor: eating, grooming, bathing, dressing - upper body, dressing - lower body, toileting, bladder management, bowel management, and transfers bed/chair/wheelchair, toilet, tub/shower, walk, stairs), and a cognitive score (FIM cognitive: auditory comprehension, verbal expression, social interaction, problem solving, and memory). Multiple studies support the reliability and validity of FIM scales in the older population.
Measure: Functional Independence Measure Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusionDescription: Acceptability (a priori, patients and caregivers for stage 2) questionnaires
Measure: Acceptability Time: Day 1 (step 2)Description: Acceptance (patients for stages 1, 3, 4 and 5) questionnaires
Measure: Acceptance Time: Day 1 (step 2)Description: Fatigue assessment (visual analog scale) (steps 1, 3, 4, 5)
Measure: Fatigue Time: End of each session, at days 1 to 9Description: Collections of possible undesirable effects by open question at the end of each session with the Virtual Reality tool (steps 1, 3, 4, 5)
Measure: Undesirable effects Time: End of each session, at days 1 to 9Description: Assessment of confidence in the future using a questionnaire (steps 1, 3, 4, 5) before the start of the first session, the day after the last session and 1 month from inclusion
Measure: Confidence in the future Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusionWith the COVID-19 pandemic, the number of patients to be treated in rehabilitation increased . Hospitalization for severe infection can induce muscular atrophy and muscular dysfunction that persists for several months and rehabilitation capacities may be exceeded. Exercises in eccentric mode could be performed, inducing greater muscular hypertrophy, muscle strength, power and speed than concentric exercises. The goal of this study was to compare functional recovery at 2 months after a training program in eccentric and concentric mode after severe COVID-19. An effective rehabilitation could help reduce costs and duration of care.
Description: Average change from baseline walking capacity measured by the 6-minutes walk test (6MWT), expressed in meters. All patients will be asked to cover the longest distance over a 30-meters distance in 6 min with or without stopping and with standardized verbal encouragements according to standard recommendations; to take into account a learning effect, the test will be performed twice, with the longer distance retained, expressed in meters. To prevent adverse effect, pulsed oxygen saturation (% of pSO²) and heart rate (heartbeat per minute) will be monitored continuously throughout the test by using a digital oximeter.
Measure: Functional walking capacity Time: Day 0, Month 1, Month 2 and Month 6Description: this test consists of assessing balance in a standing position, lifting from a chair (5 stand to-sit repetitions) and measuring 4-m walking speed (20). The patient walks 4 m at a normal and comfortable speed. The "test zone" (4 m) is preceded by an "acceleration zone" (1 m) and is followed by a "deceleration zone" (1 m). The assessor starts and stops the timing when the subject's foot meets the ground when entering and leaving the "test area", respectively.
Measure: Evaluating of lower extremity functioning by Short Physical Performance Battery (SPPB) score Time: Day 0, Month 2 and Month 6Description: maximum muscle strength of the quadriceps, on the dominant limb, will be measured on a bench: - Strength during isometric contraction (at 90° knee flexion) - Standardized position with the arms crossed on the chest, the absence of back support during the measurement and the maintenance of the hips and the contralateral leg to avoid any compensating movement Three reproducible measurements (±10%) will be taken at 1-min intervals, with the highest value retained.
Measure: Evaluating the maximum muscle strength of the quadriceps by Quadriceps Isometric Maximum Strength (QIMS) test Time: Day 0, Month 2Description: this test consists of performing 10 knee extensions at 10% QIMS, then gradually increasing the load (10% by 10%) until exhaustion (cannot perform the movement 2 consecutive times). The value retained is the last level (% QIMS) performed.
Measure: Evaluating the fatigability of the quadriceps by Quadriceps Intermittent Fatigue (QIF) test Time: Day 0, Month 2Description: this scale explores cognitive (10 items), physical (9 items) and psychosocial (2 items) fatigue. The MFIS included 21 items with a total score ranging from 0 to 84 with higher scores indicating a greater impact of quality of life.
Measure: Evaluating the global fatigability by Modified Fatigue Impact Scale (MFIS) Time: Day 0, Month 2 and Month 6Description: This questionnaire explores 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D-5L included 5 items independently scored from 1 to 5 (higher scores indicating a greater impact)and a 0-100 visual analogic scale exploring general health (0 means the worst heath patient can imagine, 100 means the best health patient can imagine).
Measure: Evaluating functional capacities with EuroQol - 5 Dimensions (EQ-5D) questionnaire Time: Day 0, Month 2 and Month 6Description: measurement is in 90° elbow flexion, wrist in neutral position. Three reproducible measurements (± 10%) will be taken at 1-min intervals, with the highest value retained.
Measure: Evaluating the handgrip strength by standard handgrip strength test Time: Day 0, Month 2Description: Plasma metabolome profile assessed by variation of number of blood metabolites. Changes from baseline to post-training intervention in plasma metabolome profile will be compared between excentric and concentric exercise groups.
Measure: Metabolomic Profile Time: Day 0, Month 2 (post-training)Description: Biopsy from the Vastus lateralis will be performed and the variation of cross sectional area measurement of muscle fibers (µm2) will be analysed and compared between excentric and concentric exercise groups from baseline to post-training intervention.
Measure: Cross sectional area measurement Time: Day 0, Month 2 (post-training)Description: Biopsy from the Vastus lateralis will be performed and the capillarization (variation of capillary to fiber ratio) will be analysed. Muscle adapations from baseline to post-training intervention will be compared between excentric and concentric exercise groups.
Measure: Capillary to fibre ratio. Time: Day 0, Month 2 (post-training)Description: Biopsy from the Vastus lateralis will be performed and the evolution of number of satellite cell per muscle fiber will be analysed and compared between excentric and concentric exercise groups from baseline to post-training intervention.
Measure: Satellite cell number Time: Day 0, Month 2 (post-training)Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
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