Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-11-22
Study Completion Date
2023-07-10
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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COVID-19
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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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.
Group Type
ACTIVE_COMPARATOR
Conventional rehabilitation
Intervention Type
OTHER
1h/day for 5 days/week of conventional rehabilitation for people wtih post-COVID-19
Aerobic exercise
Addition of aerobic exercise to conventional inpatient rehabilitation treatment for people wtih post-COVID-19.
Group Type
ACTIVE_COMPARATOR
Conventional rehabilitation
Intervention Type
OTHER
1h/day for 5 days/week of conventional rehabilitation for people wtih post-COVID-19
Aerobic exercise
Intervention Type
OTHER
30 min/day of aerobic exercise added to 1h/day for 5 days/week of conventional rehabilitation for people wtih post-COVID-19
Interventions
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Conventional rehabilitation
1h/day for 5 days/week of conventional rehabilitation for people wtih post-COVID-19
Intervention Type
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
Intervention Type
OTHER
Eligibility Criteria
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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.
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)
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)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Istituti Clinici Scientifici Maugeri SpA
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Stefano Corna, MD
Role: PRINCIPAL_INVESTIGATOR
Istituti Clinici Scientifici Maugeri SpA
Locations
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Istituti Clinici Scientifici Maugeri
Veruno, Novara, Italy
Site Status
Countries
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Italy
References
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Abate SM, Ahmed Ali S, Mantfardo B, Basu B. Rate of Intensive Care Unit admission and outcomes among patients with coronavirus: A systematic review and Meta-analysis. PLoS One. 2020 Jul 10;15(7):e0235653. doi: 10.1371/journal.pone.0235653. eCollection 2020.
Reference Type
BACKGROUND
Barnato AE, Albert SM, Angus DC, Lave JR, Degenholtz HB. Disability among elderly survivors of mechanical ventilation. Am J Respir Crit Care Med. 2011 Apr 15;183(8):1037-42. doi: 10.1164/rccm.201002-0301OC. Epub 2010 Nov 5.
Reference Type
BACKGROUND
Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31.
Reference Type
BACKGROUND
Belli S, Balbi B, Prince I, Cattaneo D, Masocco F, Zaccaria S, Bertalli L, Cattini F, Lomazzo A, Dal Negro F, Giardini M, Franssen FME, Janssen DJA, Spruit MA. Low physical functioning and impaired performance of activities of daily life in COVID-19 patients who survived hospitalisation. Eur Respir J. 2020 Oct 15;56(4):2002096. doi: 10.1183/13993003.02096-2020. Print 2020 Oct.
Reference Type
BACKGROUND
Bohannon RW. Sit-to-stand test for measuring performance of lower extremity muscles. Percept Mot Skills. 1995 Feb;80(1):163-6. doi: 10.2466/pms.1995.80.1.163.
Reference Type
BACKGROUND
Fess E, Moran C. Clinical assessment recommendations: American Society of Hand Therapists. Chicago: The Society; 1981.
Reference Type
BACKGROUND
Gemelli Against COVID-19 Post-Acute Care Study Group. Post-COVID-19 global health strategies: the need for an interdisciplinary approach. Aging Clin Exp Res. 2020 Aug;32(8):1613-1620. doi: 10.1007/s40520-020-01616-x. Epub 2020 Jun 11.
Reference Type
BACKGROUND
Guler SA, Ebner L, Aubry-Beigelman C, Bridevaux PO, Brutsche M, Clarenbach C, Garzoni C, Geiser TK, Lenoir A, Mancinetti M, Naccini B, Ott SR, Piquilloud L, Prella M, Que YA, Soccal PM, von Garnier C, Funke-Chambour M. Pulmonary function and radiological features 4 months after COVID-19: first results from the national prospective observational Swiss COVID-19 lung study. Eur Respir J. 2021 Apr 29;57(4):2003690. doi: 10.1183/13993003.03690-2020. Print 2021 Apr.
Reference Type
BACKGROUND
Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.
Reference Type
BACKGROUND
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
Reference Type
BACKGROUND
Landi F, Barillaro C, Bellieni A, Brandi V, Carfi A, D'Angelo M, Fusco D, Landi G, Lo Monaco R, Martone AM, Marzetti E, Pagano F, Pais C, Russo A, Salini S, Tosato M, Tummolo A, Benvenuto F, Bramato G, Catalano L, Ciciarello F, Martis I, Rocchi S, Rota E, Salerno A, Tritto M, Sgadari A, Zuccala G, Bernabei R. The New Challenge of Geriatrics: Saving Frail Older People from the SARS-COV-2 Pandemic Infection. J Nutr Health Aging. 2020;24(5):466-470. doi: 10.1007/s12603-020-1356-x. No abstract available.
Reference Type
BACKGROUND
Paneroni M, Simonelli C, Saleri M, Bertacchini L, Venturelli M, Troosters T, Ambrosino N, Vitacca M. Muscle Strength and Physical Performance in Patients Without Previous Disabilities Recovering From COVID-19 Pneumonia. Am J Phys Med Rehabil. 2021 Feb 1;100(2):105-109. doi: 10.1097/PHM.0000000000001641.
Reference Type
BACKGROUND
Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
Reference Type
BACKGROUND
Rawal G, Yadav S, Kumar R. Post-intensive Care Syndrome: an Overview. J Transl Int Med. 2017 Jun 30;5(2):90-92. doi: 10.1515/jtim-2016-0016. eCollection 2017 Jun.
Reference Type
BACKGROUND
Rodriguez-Morales AJ, Cardona-Ospina JA, Gutierrez-Ocampo E, Villamizar-Pena R, Holguin-Rivera Y, Escalera-Antezana JP, Alvarado-Arnez LE, Bonilla-Aldana DK, Franco-Paredes C, Henao-Martinez AF, Paniz-Mondolfi A, Lagos-Grisales GJ, Ramirez-Vallejo E, Suarez JA, Zambrano LI, Villamil-Gomez WE, Balbin-Ramon GJ, Rabaan AA, Harapan H, Dhama K, Nishiura H, Kataoka H, Ahmad T, Sah R; Latin American Network of Coronavirus Disease 2019-COVID-19 Research (LANCOVID-19). Electronic address: https://www.lancovid.org. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Mar-Apr;34:101623. doi: 10.1016/j.tmaid.2020.101623. Epub 2020 Mar 13.
Reference Type
BACKGROUND
Rooney S, Webster A, Paul L. Systematic Review of Changes and Recovery in Physical Function and Fitness After Severe Acute Respiratory Syndrome-Related Coronavirus Infection: Implications for COVID-19 Rehabilitation. Phys Ther. 2020 Sep 28;100(10):1717-1729. doi: 10.1093/ptj/pzaa129.
Reference Type
BACKGROUND
Simpson R, Robinson L. Rehabilitation After Critical Illness in People With COVID-19 Infection. Am J Phys Med Rehabil. 2020 Jun;99(6):470-474. doi: 10.1097/PHM.0000000000001443.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Washburn RA, Smith KW, Jette AM, Janney CA. The Physical Activity Scale for the Elderly (PASE): development and evaluation. J Clin Epidemiol. 1993 Feb;46(2):153-62. doi: 10.1016/0895-4356(93)90053-4.
Reference Type
BACKGROUND
Other Identifiers
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2592 CE
Identifier Type: -
Identifier Source: org_study_id
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