Aerobic Exercise in People With Post-COVID-19

July 20, 2023 updated by: Istituti Clinici Scientifici Maugeri SpA

Effects of Aerobic Exercise in People With Post-COVID-19: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Novara
      • Veruno, Novara, Italy, 28010
        • Istituti Clinici Scientifici Maugeri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 2 weeks
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.
Up to 2 weeks
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.
Up to 2 weeks
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.
Up to 2 weeks
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.
Up to 2 weeks
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).
Up to 2 weeks
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).
Up to 100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Investigators

  • Principal Investigator: Stefano Corna, MD, Istituti Clinici Scientifici Maugeri SpA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

July 10, 2023

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2592 CE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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