Tele-rehabilitation Program After Hospitalization for COVID-19

NCT04821934 | Completed

• 1 other identifier: ICS Maugeri 2514 CE
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief Summary

Given the number of hospitalized subjects for COVID-19, the difficulties linked to the infectious risk, and the high cost of managing departments for COVID-19 subjects, the execution of home rehabilitation programs, in the form of telerehabilitation, was suggested as a viable option. The aim of our study will be to investigate the effectiveness of a structured telerehabilitation program with a specific rehabilitation intervention on exercise tolerance at home in the subject discharged after hospitalization for COVID-19 pneumonia, in comparison to a traditional remote monitoring program (without any rehabilitation intervention). Other secondary objectives will be the evaluation of safety, feasibility, clinical impact on symptom status (asthenia, dyspnea), gas exchange (day, night and under exertion), lung function, muscle strength, functional capacity and quality of life.

Conditions

COVID-19 Pneumonia

Keywords

Covid-19; covid; pulmonary rehabilitation; physiotherapist; telerehabilitation; telemedicine; exercise

Outcome Measures

Primary Outcomes (1)

• Change in 6 Minute Walking Test

  The 6MWT is a self-paced test of walking capacity. Patients will be asked to walk as far as possible in 6 min along a flat corridor. The distance in metres is recorded. Standardised instructions and encouragement are given during the test. Predicted 6MW Distance follows this calculation: 361-(age in yrs x 4) + (height in cm x 2) + (HRmax/HRmax % pred x 3) - (weight in kg x 1.5) - 30 (if females).

  baseline and 1 month and 3 months

Secondary Outcomes (7)

• Respiratory evaluations

  baseline and 1 month

• Respiratory muscle strength

  baseline and 1 month

• Functional evaluations - 1 Minute Sit To Stand

  baseline and 1 month

• Functional capacity with Short Physical Performance Battery (SPPB)

  baseline and 1 month

• Clinical symptoms with Barthel Dyspnea Index

  baseline and 1 month

Study Arms (2)

Telerehabilitation (TR) at home + Telesurveillance program (TSu)

EXPERIMENTAL

These COVID-19 patients will enter the usual telesurveillance program together with a specific remote rehabilitation program on exercise activity.

Other: TR

Telesurveillance (TSu) alone

ACTIVE COMPARATOR

These COVID-19 patients will enter the usual remote telesurveillance program

Other: TSu

Interventions

TR OTHER

TR is a specific remote tele rehabilitation program on exercise activity managed by the physiotherapist (PT) at home, this is the experimental group. PT will explain the rehabilitation program at hospital discharge by the use of a brochure and videos. TR will include an early exercise re-conditioning program \[aerobic exercise at the free body (with or without tools), cyclette and walking with a pedometer\] comprising 20 sessions of 60 minutes/day, 6 out of 7 days to be performed at home, for one month after discharge. The sessions will be self-managed by the patients 4 times a week and an expert PT will remotely supervise 2 times a week through a dedicated platform. The program will be progressively incremental and divided into 4 different levels of intensity (0- 3). In addition to this specific rehabilitation program, the patients will be followed by a nurse tutor once a day for two weeks and once a week for a further two weeks in a program of Telesurveillance.

Also known as: Telerehabilitation

Telerehabilitation (TR) at home + Telesurveillance program (TSu)

TSu OTHER

The patients of this group will perform a usual Telesurveillance and will be considered as control group. All patients, at discharge from the hospital, will be provided with a finger pulse oximeter and a dedicated application (app) on their personal smartphone and will be advised on free physical activity to be performed at home. The nurse will check through scheduled calls (once a day for two weeks and once a week for a further two weeks) the patient's health condition, vital parameters and drugs administration. Patients will be able to contact the nurse at each time, in case of specific need, out of the scheduled call, 7/7 days. A follow up by phone will be planned by nurse tutor at 2 months from the end of the study.

Also known as: Telesurveillance

Telesurveillance (TSu) alone

Eligibility Criteria

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

You may qualify if:

• One or both the following points:
• need for 24-hour oxygen therapy to have a resting SpO2 of at least 94% or exercise-induced desaturation, defined as a reduction of at least 3% of SpO2 mean measured during the 6-minute test (6MWT) compared to SpO2 measured at rest
• reduced tolerance to effort highlighted by the 6MWT with a value of the meters travelled less than 70 percent of the predicted one

You may not qualify if:

• Hemodynamic instability and the presence of uncontrolled cardiac arrhythmias
• Any clinical condition that contraindicates aerobic exercise
• Presence of motor disability before hospitalization which made it impossible to walk independently (Rankin scale\> 3) (10)
• Impaired cognitive status (Mini Mental State Examination test \<24)
• Inability to use (by the patient or a caregiver) the technological means sufficient to follow the program (mobile phone with internet connection)
• Lack of supervision by a caregiver in case of walking and standing instability Contacts/Locations

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Istituto Auxologico Italiano: collaborator

Study Sites (2)

S Maugeri IRCCS, U.O. Emergenza Coronavirus di Lumezzane

Brescia, 25065, Italy

Location

ICS Maugeri IRCCS, U.O. Emergenza Coronavirus di Tradate

Varese, 21100, Italy

Location

Related Publications (16)

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• 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.

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• 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.

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• Simonelli C, Paneroni M, Fokom AG, Saleri M, Speltoni I, Favero I, Garofali F, Scalvini S, Vitacca M. How the COVID-19 infection tsunami revolutionized the work of respiratory physiotherapists: an experience from Northern Italy. Monaldi Arch Chest Dis. 2020 May 19;90(2). doi: 10.4081/monaldi.2020.1085.

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• Vaidya T, de Bisschop C, Beaumont M, Ouksel H, Jean V, Dessables F, Chambellan A. Is the 1-minute sit-to-stand test a good tool for the evaluation of the impact of pulmonary rehabilitation? Determination of the minimal important difference in COPD. Int J Chron Obstruct Pulmon Dis. 2016 Oct 19;11:2609-2616. doi: 10.2147/COPD.S115439. eCollection 2016.

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• Vitacca M, Paneroni M, Baiardi P, De Carolis V, Zampogna E, Belli S, Carone M, Spanevello A, Balbi B, Bertolotti G. Development of a Barthel Index based on dyspnea for patients with respiratory diseases. Int J Chron Obstruct Pulmon Dis. 2016 Jun 7;11:1199-206. doi: 10.2147/COPD.S104376. eCollection 2016.

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• Paneroni M, Scalvini S, Perger E, Zampogna E, Govetto S, Oliva FM, Matrone A, Bernocchi P, Rosa D, Vitacca M. Home-based exercise program for people with residual disability following hospitalization for COVID-19: Randomized control trial. Ann Phys Rehabil Med. 2024 Mar;67(2):101815. doi: 10.1016/j.rehab.2023.101815. Epub 2024 Mar 12.

  PMID: 38479344 DERIVED

MeSH Terms

Conditions

COVID-19; Motor Activity

Interventions

Telerehabilitation

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; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Mara Paneroni, PT

  Istituti Clinici Scientifici Maugeri

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 30, 2021
• Study Start: March 26, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: October 18, 2024

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)