Aerobic Exercise in People With Post-COVID-19

NCT05302973 | Completed DMC

• 1 other identifier: 2592 CE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

aerobic exercise; rehabilitation; COVID-19

Outcome Measures

Primary Outcomes (1)

• Analysis of feasibility

  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 Outcomes (7)

• Timed Up and Go (TUG) test

  Up to 2 weeks

• Muscle torque of knee extensors

  Up to 2 weeks

• Handgrip strength

  Up to 2 weeks

• 1-minute sit-to-stand test (1STST)

  Up to 2 weeks

• Cumulated Ambulation Score - Italian version (CAS-I)

  Up to 2 weeks

Study Arms (2)

Conventional rehabilitation

ACTIVE COMPARATOR

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

Aerobic exercise

ACTIVE COMPARATOR

Addition of aerobic exercise to conventional inpatient rehabilitation treatment for people wtih post-COVID-19.

Other: Conventional rehabilitation; Other: Aerobic exercise

Interventions

Conventional rehabilitation OTHER

1h/day for 5 days/week of conventional rehabilitation for people wtih post-COVID-19

Aerobic exercise; Conventional rehabilitation

Aerobic exercise OTHER

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

Aerobic exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri

Veruno, Novara, 28010, Italy

Location

Related Publications (19)

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MeSH Terms

Conditions

COVID-19

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stefano Corna, MD

  Istituti Clinici Scientifici Maugeri SpA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 31, 2022
• Study Start: November 22, 2021
• Primary Completion: December 31, 2022
• Study Completion: July 10, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

IT (1)