COVID-19 PneumoniaNCT04821934

Tele-rehabilitation Program After Hospitalization for COVID-19

A study testing TR and TSu in people with COVID-19 Pneumonia, run by Istituti Clinici Scientifici Maugeri SpA at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19 Pneumonia
What is being tested?: TR and TSu
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 2 sitesItaly
Study dates: 26 Mar 2021to 20 Dec 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

S Maugeri IRCCS, U.O. Emergenza Coronavirus di Lumezzane
Brescia, 25065
ICS Maugeri IRCCS, U.O. Emergenza Coronavirus di Tradate
Varese, 21100

Other trials in Italy

About this study

Official title: Efficacy of a Tele-rehabilitation Program After Hospitalization for COVID-19 Pneumonia: a Randomized Controlled Trial

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.

Read the detailed description

The rapid spread of Covid-19 has produced a large number of hospitalized patients, even for relatively long problems and with the need for intensive or sub-intensive care.

Upon discharge from the hospital, some studies have shown that the majority of subjects with COVID-19 present a reduction in functional capacity, exercise tolerance and muscle strength, regardless of previous health status and pre-existing disabilities. Furthermore, some works on patients suffering from similar respiratory infections, such as SARS or MERS, have described how a functional deficit can persist even in the long term. An early rehabilitation intervention, which included aerobic reconditioning, was tested in some pilot observational studies in hospitalized subjects for COVID-19, and proved feasible and safe. A single randomized controlled Chinese study has documented the efficacy of an acute respiratory rehabilitation intervention. 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. Telerehabilitation programs that included effort re-conditioning, intended for subjects with reduced functional capacity, have already been successfully proposed in cardiac, respiratory, orthopedic, and neurological patients. No studies until now have described the feasibility, safety and efficacy of early exercise reconditioning treatment to improve disability in the subject discharged after hospitalization for COVID-19 pneumonia.

Conditions: COVID-19 Pneumonia
Being tested: TR, TSu
Keywords: Covid-19, covid, pulmonary rehabilitation, physiotherapist, telerehabilitation, telemedicine, exercise
Medical subject headings: COVID-19, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TROther
Also called Telerehabilitation
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.
TSuOther
Also called Telesurveillance
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.

Study groups in NCT04821934
Study group	Role	What they receive
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. Receives: Other: TR
Telesurveillance (TSu) alone	Active comparator	These COVID-19 patients will enter the usual remote telesurveillance program Receives: Other: TSu

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: baseline and 1 month and 3 months

Secondary outcomes (7)

Respiratory evaluations
Measures of FiO2 (%), PaO2 (mmHg), PaCO2 (mmHg), pH
Measured: baseline and 1 month
Respiratory muscle strength
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements may aid in evaluating respiratory muscle weakness. Patient needs to inspire and exhale into a rigid mouthpiece that does not allow the dispersion of the air blown by him. The mouthpiece is connected to a blood pressure monitor and is equipped with a valve that is closed before the patient breathes in or out with maximum force.
Measured: baseline and 1 month
Functional evaluations - 1 Minute Sit To Stand
The therapists will ask the participants to sit down on a chair without arm rests and then up from the chair. The assisted use of the arms is not allowed during the STS test. The therapists will instruct the participants to complete as many sit-to-stand cycles as possible within 60 seconds at self-paced speed and count the number of fully-completed STS cycles. The median number of repetitions ranged from 50/min (25-75th percentile 41-57/min) in young men and 47/min (39-55/min) in young women aged 20-24 years to 30/min (25-37/min) in older men and 27/min (22-30/min) in older women aged 75-79 years.
Measured: baseline and 1 month
Functional capacity with Short Physical Performance Battery (SPPB)
This is a test to evaluate lower limbs' function. The SPPB represents the sum of results from three functional tests: standing balance, 4-meter gait speed (4-MGS) and five-repetition sit-to-stand (5-STS) manoeuvre. Each component is scored based on a subscale, and the three sub-scores are added to obtain a summary score. Scores between 0-3 denote severe physical function disability, 4-6 low function, 7-9 intermediate function, and 10-12 normal function. Predicted values for the SPPB were calculated using normative values for total SPPB score and a European population aged ≥40 years, stratified for age and sex.
Measured: baseline and 1 month
Clinical symptoms with Barthel Dyspnea Index
The Barthel Dyspnea Index is a scale used to measure patients' dyspnea during activity of daily living (ADL). It's composed by 10 items; the best score is 100 and higher is the score, less is the dyspnea.
Measured: baseline and 1 month
Fatigue Severity Scale
The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities.
Measured: baseline and 1 month
SF-12
The SF-12 is a questionnaire with 12 questions to measure functional health and well-being (QoL) from the patient's perspective. It measures 8 health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Two summary scores are reported from the SF-12: a mental component score (MCS-12) and a physical component score (PCS-12). An algorithm establishes the score; lower values correspond to a worse quality of life, while higher values correspond to a better quality of life.
Measured: baseline and 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 202120 Dec 2021

First posted30 Mar 2021
Study start26 Mar 2021
Primary completion20 Dec 2021
Study completion20 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04821934
Sponsor's protocol ID: ICS Maugeri 2514 CE
Status last verified: Aug 2022
First submitted: 26 Mar 2021
Last updated: 18 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Vitacca M, Lazzeri M, Guffanti E, Frigerio P, D'Abrosca F, Gianola S, Carone M, Paneroni M, Ceriana P, Pasqua F, Banfi P, Gigliotti F, Simonelli C, Cirio S, Rossi V, Beccaluva CG, Retucci M, Santambrogio M, Lanza A, Gallo F, Fumagalli A, Mantero M, Castellini G, Calabrese M, Castellana G, Volpato E, Ciriello M, Garofano M, Clini E, Ambrosino N; Associazione Italiana Pneumologi Ospedalieri; Associazione Riabilitatori dell'Insufficienza Respiratoria; Societa Italiana di Pneumologia; Associazione Italiana Fisioterapisti; Societa Italiana di Fisioterapia E Riabilitazione. Italian suggestions for pulmonary rehabilitation in COVID-19 patients recovering from acute respiratory failure: results of a Delphi process. Monaldi Arch Chest Dis. 2020 Jun 23;90(2). doi: 10.4081/monaldi.2020.1444.
PubMed 32573175
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.
PubMed 32764112
Van Aerde N, Van den Berghe G, Wilmer A, Gosselink R, Hermans G; COVID-19 Consortium. Intensive care unit acquired muscle weakness in COVID-19 patients. Intensive Care Med. 2020 Nov;46(11):2083-2085. doi: 10.1007/s00134-020-06244-7. Epub 2020 Sep 28. No abstract available.
PubMed 32986233
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.
PubMed 33181531
Hui DS, Wong KT, Ko FW, Tam LS, Chan DP, Woo J, Sung JJ. The 1-year impact of severe acute respiratory syndrome on pulmonary function, exercise capacity, and quality of life in a cohort of survivors. Chest. 2005 Oct;128(4):2247-61. doi: 10.1378/chest.128.4.2247.
PubMed 16236881
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.
PubMed 32431134
Liu K, Zhang W, Yang Y, Zhang J, Li Y, Chen Y. Respiratory rehabilitation in elderly patients with COVID-19: A randomized controlled study. Complement Ther Clin Pract. 2020 May;39:101166. doi: 10.1016/j.ctcp.2020.101166. Epub 2020 Apr 1.
PubMed 32379637
Chirra M, Marsili L, Wattley L, Sokol LL, Keeling E, Maule S, Sobrero G, Artusi CA, Romagnolo A, Zibetti M, Lopiano L, Espay AJ, Obeidat AZ, Merola A. Telemedicine in Neurological Disorders: Opportunities and Challenges. Telemed J E Health. 2019 Jul;25(7):541-550. doi: 10.1089/tmj.2018.0101. Epub 2018 Aug 23.
PubMed 30136898
Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
PubMed 25359355
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.
PubMed 27799759
Strassmann A, Steurer-Stey C, Lana KD, Zoller M, Turk AJ, Suter P, Puhan MA. Population-based reference values for the 1-min sit-to-stand test. Int J Public Health. 2013 Dec;58(6):949-53. doi: 10.1007/s00038-013-0504-z. Epub 2013 Aug 24.
PubMed 23974352
Pavasini R, Guralnik J, Brown JC, di Bari M, Cesari M, Landi F, Vaes B, Legrand D, Verghese J, Wang C, Stenholm S, Ferrucci L, Lai JC, Bartes AA, Espaulella J, Ferrer M, Lim JY, Ensrud KE, Cawthon P, Turusheva A, Frolova E, Rolland Y, Lauwers V, Corsonello A, Kirk GD, Ferrari R, Volpato S, Campo G. Short Physical Performance Battery and all-cause mortality: systematic review and meta-analysis. BMC Med. 2016 Dec 22;14(1):215. doi: 10.1186/s12916-016-0763-7.
PubMed 28003033
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.
PubMed 27354778
Ottonello M, Pellicciari L, Giordano A, Foti C. Rasch analysis of the Fatigue Severity Scale in Italian subjects with multiple sclerosis. J Rehabil Med. 2016 Jul 18;48(7):597-603. doi: 10.2340/16501977-2116.
PubMed 27344968
Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7.
PubMed 9817135

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of a Tele-rehabilitation Program After Hospitalization for COVID-19 Pneumonia: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04821934
Acronym / sponsor ID: ICS Maugeri 2514 CE
Conditions: COVID-19 Pneumonia
Keywords: Covid-19, covid, pulmonary rehabilitation, physiotherapist, telerehabilitation, telemedicine, exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
Collaborators: Istituto Auxologico Italiano
Study start: 26 Mar 2021 (actual)
Primary completion: 20 Dec 2021 (actual)
Study completion: 20 Dec 2021 (actual)
First posted: 30 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The rapid spread of Covid-19 has produced a large number of hospitalized patients, even for relatively long problems and with the need for intensive or sub-intensive care.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Telerehabilitation (TR) at home + Telesurveillance program (TSu)	Experimental	Other: TRThese COVID-19 patients will enter the usual telesurveillance program together with a specific remote rehabilitation program on exercise activity.
Telesurveillance (TSu) alone	Active comparator	Other: TSuThese COVID-19 patients will enter the usual remote telesurveillance program

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

One or both the following points:

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TRAlso: TelerehabilitationTR 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.	Other	Telerehabilitation (TR) at home + Telesurveillance program (TSu)
TSuAlso: TelesurveillanceThe 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.	Other	Telesurveillance (TSu) alone

Primary outcome

Change in 6 Minute Walking Test
Time frame: baseline and 1 month and 3 months
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).

7 secondary outcomes

Respiratory evaluations
Time frame: baseline and 1 month
Respiratory muscle strength
Time frame: baseline and 1 month
Functional evaluations - 1 Minute Sit To Stand
Time frame: baseline and 1 month
Functional capacity with Short Physical Performance Battery (SPPB)
Time frame: baseline and 1 month
Clinical symptoms with Barthel Dyspnea Index
Time frame: baseline and 1 month
Fatigue Severity Scale
Time frame: baseline and 1 month
SF-12
Time frame: baseline and 1 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
Background: PubMed 32573175Vitacca M, Lazzeri M, Guffanti E, Frigerio P, D'Abrosca F, Gianola S, Carone M, Paneroni M, Ceriana P, Pasqua F, Banfi P, Gigliotti F, Simonelli C, Cirio S, Rossi V, Beccaluva CG, Retucci M, Santambrogio M, Lanza A, Gallo F, Fumagalli A, Mantero M, Castellini G, Calabrese M, Castellana G, Volpato E, Ciriello M, Garofano M, Clini E, Ambrosino N; Associazione Italiana Pneumologi Ospedalieri; Associazione Riabilitatori dell'Insufficienza Respiratoria; Societa Italiana di Pneumologia; Associazione Italiana Fisioterapisti; Societa Italiana di Fisioterapia E Riabilitazione. Italian suggestions for pulmonary rehabilitation in COVID-19 patients recovering from acute respiratory failure: results of a Delphi process. Monaldi Arch Chest Dis. 2020 Jun 23;90(2). doi: 10.4081/monaldi.2020.1444.
Background: PubMed 32764112Belli 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.
Background: PubMed 32986233Van Aerde N, Van den Berghe G, Wilmer A, Gosselink R, Hermans G; COVID-19 Consortium. Intensive care unit acquired muscle weakness in COVID-19 patients. Intensive Care Med. 2020 Nov;46(11):2083-2085. doi: 10.1007/s00134-020-06244-7. Epub 2020 Sep 28. No abstract available.
Background: PubMed 33181531Paneroni 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.
Background: PubMed 16236881Hui DS, Wong KT, Ko FW, Tam LS, Chan DP, Woo J, Sung JJ. The 1-year impact of severe acute respiratory syndrome on pulmonary function, exercise capacity, and quality of life in a cohort of survivors. Chest. 2005 Oct;128(4):2247-61. doi: 10.1378/chest.128.4.2247.
Background: PubMed 32431134Simonelli 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.
Background: PubMed 32379637Liu K, Zhang W, Yang Y, Zhang J, Li Y, Chen Y. Respiratory rehabilitation in elderly patients with COVID-19: A randomized controlled study. Complement Ther Clin Pract. 2020 May;39:101166. doi: 10.1016/j.ctcp.2020.101166. Epub 2020 Apr 1.
Background: PubMed 30136898Chirra M, Marsili L, Wattley L, Sokol LL, Keeling E, Maule S, Sobrero G, Artusi CA, Romagnolo A, Zibetti M, Lopiano L, Espay AJ, Obeidat AZ, Merola A. Telemedicine in Neurological Disorders: Opportunities and Challenges. Telemed J E Health. 2019 Jul;25(7):541-550. doi: 10.1089/tmj.2018.0101. Epub 2018 Aug 23.
Background: PubMed 25359355Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
Background: PubMed 27799759Vaidya 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.
Background: PubMed 23974352Strassmann A, Steurer-Stey C, Lana KD, Zoller M, Turk AJ, Suter P, Puhan MA. Population-based reference values for the 1-min sit-to-stand test. Int J Public Health. 2013 Dec;58(6):949-53. doi: 10.1007/s00038-013-0504-z. Epub 2013 Aug 24.
Background: PubMed 28003033Pavasini R, Guralnik J, Brown JC, di Bari M, Cesari M, Landi F, Vaes B, Legrand D, Verghese J, Wang C, Stenholm S, Ferrucci L, Lai JC, Bartes AA, Espaulella J, Ferrer M, Lim JY, Ensrud KE, Cawthon P, Turusheva A, Frolova E, Rolland Y, Lauwers V, Corsonello A, Kirk GD, Ferrari R, Volpato S, Campo G. Short Physical Performance Battery and all-cause mortality: systematic review and meta-analysis. BMC Med. 2016 Dec 22;14(1):215. doi: 10.1186/s12916-016-0763-7.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mara Paneroni, PT principal investigator

Istituti Clinici Scientifici Maugeri

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TR and TSu in people with COVID-19 Pneumonia, run by Istituti Clinici Scientifici Maugeri SpA at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 6 Minute Walking Test (time frame: baseline and 1 month and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04821934, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.