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Aerobic Exercise in People With Post-COVID-19

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ClinicalTrials.gov Identifier: NCT05302973
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Istituti Clinici Scientifici Maugeri SpA

Brief Summary:
The primary aim of this study is to study the feasibility of an aerobic training, in addition to conventional rehabilitation, in patients post sequela of interstitial pneumonia due to COVID-19. In particular, we wish to verify if patients could tolerate this kind of physical activity and if there are any adverse effects. The secondary aim is to evaluate if the aerobic exercise is effective in improving functional capacity and gait performance in these patients respect to the common physiotherapy.

Condition or disease Intervention/treatment Phase
COVID-19 Other: Conventional rehabilitation Other: Aerobic exercise Not Applicable

Detailed Description:

The coronavirus disease 2019 (COVID-19) is an infectious disease caused by SARS-CoV-2 that mainly affects the respiratory system (Landi et al., 2020). While the majority (80%) of people infected with COVID-19 presents mild to moderate disease (Huang et al., 2020; Rodriguez-Morales et al. 2020), for a considerable number of subjects, generally >65 years and with comorbidities, the infection can have very serious sequelae (about 20%) (Yang et al., 2020). Of those requiring hospitalization, a high portion (20%) require management in the intensive care unit (ICU) often for an acute respiratory distress syndrome (ARDS) (Simpson and Robinson, 2020).

People with critical illness due to COVID-19 has not only a disease primarily affecting the lung, but present also a multi-organ involvement (Gemelli Against COVID-19 Post-Acute Care Study Group, 2020). During periods of critical illness and hospitalization, it is common to experience a loss of physical function (Rawal et al., 2017), characterized by the development of new or worsening of existing impairments. This decrease in physical functioning is thought to be attributed to prolonged periods of immobility, during which time people experience deconditioning, develop critical illness, polyneuropathy and myopathy (Rooney et al., 2020). This results in a motor disability and a reduction of independence in the activities of daily living (ADL) (Abate et al., 2020; Rodriguez-Morales et al. 2020; Herridge et al. 2011; Barnato et al., 2011).

Several authors reported that people with COVID-19 - even without motor limitation prior to hospitalization - in the post-acute phase show muscle weakness, reduced physical performance, exercise-induced oxygen desaturation and hampered performance of ADLs still when discharged home (Belli et al., 2020; Paneroni et al., 2020). In those with severe and critical COVID-19 course, the impairments in pulmonary function and physical performance may be identified four months after the infection (Guler et al., 2021). These findings suggest that there is a clear need to plan for post-acute and chronic rehabilitation for people recovering from COVID-19 (Barker-Davies et al., 2020).

People with COVID-19 are heterogeneous, with different manifestations and comorbidities, and show disabling sequelae when recovering from the infection. Consequently, rehabilitation, which is necessary for facilitating the recovery and the discharge to home, has to be patient-centered and tailored to individual patient needs and impairments (Barker-Davies et al., 2020).

Therefore, it may be useful to conduct a prospective longitudinal study on subjects with COVID-19 who have undergone a period of hospitalization for severe or critical COVID-19 and who were discharged from the post-acute ward to a rehabilitation post-COVID-19 ward. Moreover, since experts strongly recommended a low-/moderate-intensity physical exercise in the first weeks following hospitalization in the COVID wards (Spruit et al., 2020), there is the need to consider the addition of an aerobic exercise training to the usual rehabilitation.

The primary purpose of this randomized controlled clinical trial is to verify the experimental aerobic training may be feasible in subjects with a sequela of interstitial pneumonia due to COVID-19 (people with post-COVID-19) and performed without the manifestation of serious adverse events.

The secondary purpose is to verify whether the addition of aerobic activity can increase physical performance compared to a program in which no aerobic activity is foreseen.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Aerobic Exercise in People With Post-COVID-19: a Randomized Controlled Trial
Actual Study Start Date : November 22, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Conventional rehabilitation
Inpatient rehabilitation - person-centred and tailored to individual participant needs - which take into account the different sequelae associated with the severity of COVID-19, the prolonged stay of people in the acute hospital or in the intensive care unit, and the pre-existing comorbidities.
Other: Conventional rehabilitation
1h/day for 5 days/week of conventional rehabilitation for people wtih post-COVID-19

Active Comparator: Aerobic exercise
Addition of aerobic exercise to conventional inpatient rehabilitation treatment for people wtih post-COVID-19.
Other: Conventional rehabilitation
1h/day for 5 days/week of conventional rehabilitation for people wtih post-COVID-19

Other: Aerobic exercise
30 min/day of aerobic exercise added to 1h/day for 5 days/week of conventional rehabilitation for people wtih post-COVID-19




Primary Outcome Measures :
  1. Analysis of feasibility [ Time Frame: Up to 2 weeks ]
    To assess the feasibility, it will be evaluated the adherence to treatment of participants enrolled in the aerobic exercise group. It will be expressed both as compliance rates, defined in terms of duration (% sessions performed reaching the goal of 30min) and prescribed intensity (% sessions performed at an intensity between 64-76% HRmax).


Secondary Outcome Measures :
  1. Timed Up and Go (TUG) test [ Time Frame: Up to 2 weeks ]
    TUG is a physical functional measure in which subjects are asked to stand up from a chair, walk 3 m to a horizontal line marked with tape on the floor, turn around, walk back and sit down at a comfortable pace (Podsiadlo and Richardson, 1991). Time in seconds necessary for perform the test will be collected.

  2. Muscle torque of knee extensors [ Time Frame: Up to 2 weeks ]
    The muscle torque of the knee extensors will be evaluated pre- and post-training with the use of a handheld dynamometer. The patient will be required to perform a sub-maximal contraction in knee extension, followed by two maximal contractions during which the physiotherapist will give verbal encouragement. The evaluation will be performed first on one limb, then on the other, with a 30-second pause between one contraction and the next. The mean value of the two right- leg and left-leg tests will be recorded. Measurements will be converted from kilo to newton.

  3. Handgrip strength [ Time Frame: Up to 2 weeks ]
    The handgrip strength will be measured bilaterally with a calibrated Jamar dynamometer. In accordance with the recommendations of the American Society of Hand Therapist, subjects will be seated with feet flat on the floor, the tested arm adducted against the body in neutral rotation, the elbow in 90° of flexion, and the forearm in neutral rotation pronation/supination (Fess and Moran, 1981). Two trials for each arm will be performed; the average of the right and left force will be recorded by the tester in kilo and then converted to newtons.

  4. 1-minute sit-to-stand test (1STST) [ Time Frame: Up to 2 weeks ]
    The 1STST is a widely implementable measure of lower body muscular strength and endurance (Bohannon, 1995) which capture the number of stands a person can complete in 1 minute without using the arms. Patients will be asked to perform repetitions of standing upright and then sitting down in the same position at a self-paced speed (safe and comfortable) as many times as possible for 1 min, without using the arms and fully sitting between each stand. The number of completed stands will be recorded. SpO2 before and after the test will be recorded.

  5. Cumulated Ambulation Score - Italian version (CAS-I) [ Time Frame: Up to 2 weeks ]
    The CAS-I is a 3-item scale assessing activities that characterize the patient's basic mobility skills: 1) getting in and out of bed, 2) sit-to-stand from a chair with armrests and 3) walking indoors with the use of appropriate walking aids. Each activity is assessed on a three-point ordinal scale from 0-2 (0 = Not able to, despite human assistance and verbal cueing, 1 = Able to, with human assistance and/or verbal cueing from one or more persons, 2 = Able to safely, without human assistance or verbal cueing, use of a walking aid allowed) resulting in a total daily CAS score ranging from zero to six.

  6. Functional Independence Measure (FIM) [ Time Frame: Up to 2 weeks ]
    This scale is a widely used tool for rating the rates patients' ADL performances. It is composed by 18 items, that is 13 motor and 5 cognitive items, each of whom is assigned a score between 7 (total independence) and 0 (total dependence). Therefore, the total FIM scores range between 18 (reflecting complete functional dependency) and 126 (reflecting complete functional independency).

  7. Physical Activity Scale for the Elderly (PASE) [ Time Frame: Up to 100 days ]
    It is a brief (5 minutes) and easily scored survey designed specifically to assess physical activity in epidemiologic studies of persons age 65 years and older. The PASE score combines information on leisure, household, and occupational activity (Washburn et al., 1993).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Defined diagnosis of interstitial pneumonia due to COVID-19;
  2. Two negative nasopharyngeal swab test for SARS-CoV-2;
  3. Functional independence before the COVID-19;
  4. Mini-mental state examination (MMSE) score > 24.

Exclusion Criteria:

  1. Positivity to COVID-19;
  2. Patients living in a nursing home or not autonomous prior to the COVID-19;
  3. Presence of moderate or severe heart disease (Grade III or IV, New York Heart Association);
  4. Presence of neurological disease;
  5. Low compliance;
  6. Patients with low rehabilitation needs (FIM total score at admission >100)
  7. Terminal illness (life expectation <6 months)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05302973


Contacts
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Contact: Stefano Corna, MD 0322 884930 ext +39 stefano.corna@icsmaugeri.it

Locations
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Italy
Istituti Clinici Scientifici Maugeri Recruiting
Veruno, Novara, Italy, 28010
Contact: Stefano Corna, MD    0322884930 ext +39    stefano.corna@icsmaugeri.it   
Principal Investigator: Stefano Corna, MD         
Sponsors and Collaborators
Istituti Clinici Scientifici Maugeri SpA
Investigators
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Principal Investigator: Stefano Corna, MD Istituti Clinici Scientifici Maugeri SpA
Publications:
Fess E, Moran C. Clinical assessment recommendations: American Society of Hand Therapists. Chicago: The Society; 1981.
Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST. Erratum In: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570.

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Responsible Party: Istituti Clinici Scientifici Maugeri SpA
ClinicalTrials.gov Identifier: NCT05302973    
Other Study ID Numbers: 2592 CE
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituti Clinici Scientifici Maugeri SpA:
aerobic exercise
rehabilitation
COVID-19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases