NCT05007457

Brief Summary

In recent months, more and more studies suggest tele-rehabilitation as a means to be exploited to reduce the risk of contagion. The intent of our study is to verify the effectiveness of a tele-rehabilitation intervention through the application of a respiratory rehabilitation program supported by contact with physiotherapists, in patients with outcomes from SARS-CoV-2 infection discharged from the various medical departments and taken over by physiotherapists after physiatric evaluation. Faced with the same rehabilitation program prescribed to all patients, the primary objective of our study is to detect whether patients supported by remote rehabilitation after hospitalization improve both adherence to the rehabilitation program and cardiorespiratory endurance and dyspnea symptoms assessed with the Six Minute Walking Test scale (6MWT). This test is validated for multiple pathologies, including idiopathic pulmonary fibrosis, the clinic of which could be comparable to the outcomes of coronavirus interstitial pneumonia as suggested by the literature. The secondary objectives concern the assessment of the impact of physical exercise assisted by tele-rehabilitation detected through: the assessment of the quality of life (Saint George Respiratory Questionnaire );the assessment of autonomy in daily life activities (Barthel Index Dyspnea Scale), the evaluation of the variation in thoracic expansion and lung volumes (with COACH , an instrument for respiratory physiotherapy that measures the inspiratory volume in ml); the evaluation of muscle strength and endurance (One Minute Sit To Stand) ; the detection of dyspnea during the execution of the exercises (Modified Borg scale); the assessment of the functionality of the lower limbs (Short Physical Performance Battery)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 12, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2023

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

April 12, 2021

Last Update Submit

August 13, 2021

Conditions

Respiratory FailureSars-CoV-2Covid19ARDSInterstitial PneumoniaRespiratory RehabilitationDyspneaQuality of LifeCoronavirus Infections

Outcome Measures

Primary Outcomes (1)

  • Six Minute Walking Test (6MWT)

    Six Minute Walking Test (6MWT) variation of more than 21.7 meters after 10 weeks of rehabilitation (the least clinically significant variation in patients with IPF - idiopathic pulmonary fibrosis - for the 6MWT is more than 21.7 meters after 6 months of rehabilitation)

    through study completion, an average of 1 year

Secondary Outcomes (6)

  • Improvement of daily living activities

    through study completion, an average of 1 year

  • Improvement of thoracic expansion and lung volumes

    through study completion, an average of 1 year

  • Improvement of muscle strength and endurance

    through study completion, an average of 1 year

  • Improvement of the quality of life

    through study completion, an average of 1 year

  • Improvement of dyspnea in the execution of life activities

    through study completion, an average of 1 year

  • +1 more secondary outcomes

Study Arms (2)

Experimental Group

EXPERIMENTAL

telerehabilitation

Other: Telerehabilitation

Control group

ACTIVE COMPARATOR

Standard treatment

Other: Telerehabilitation

Interventions

TelerehabilitationOTHER

Patients belonging to the experimental group will receive the brochure and, weekly a telematic comparison will take place lasting about 30 minutes, with a physiotherapist to be asked questions. The physiotherapist will be able to evaluate and modify the training program based on the patient's response. The tele-rehabilitation sessions will take place: once / week for the first month, once every 2 weeks for the second month and from the third month from the third month the patient can contact the professionals in case of doubts or questions regarding the exercises he is taking place at home.

Control groupExperimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of COVID19;
  • Respiratory failure in Sars-Cov2 pneumonia;
  • ARDS in Sars-Cov2 pneumonia;
  • Interstitial pneumonia from Sars-Cov2;
  • Rankin scale ≥ 3/5 before enrollment (therefore at discharge);
  • Patients in need of rehabilitation;
  • Patients discharged from the hospital at their home;
  • Patients with internet access;
  • Owners and users of smartphones / tablets / PCs;
  • Owners a pedal / stationary bike and oximeter.

You may not qualify if:

  • Asymptomatic or paucisymptomatic patient;
  • Institutionalized person;
  • Unstable angina;
  • Recent IMA;
  • Life expectancy \<12 months for other comorbidities (eg advanced cancer).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angela Peghetti

Bologna, BO, 40138, Italy

RECRUITING

Related Publications (1)

  • Chen X, Jiang J, Wang R, Fu H, Lu J, Yang M. Chest physiotherapy for pneumonia in adults. Cochrane Database Syst Rev. 2022 Sep 6;9(9):CD006338. doi: 10.1002/14651858.CD006338.pub4.

    PMID: 36066373DERIVED

MeSH Terms

Conditions

Respiratory InsufficiencyCOVID-19Lung Diseases, InterstitialDyspneaCoronavirus Infections

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Carolina Guerrieri, Director

    AOSP Bologna

    STUDY DIRECTOR

Central Study Contacts

Angela Peghetti

CONTACT

+393314028226angela.peghetti@aosp.bo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Partecipants, care providers and investigators are blinded only at the time of enrollment, subsequently they will learn about the group in which the partecipants were placed
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Nurse

Study Record Dates

First Submitted

April 12, 2021

First Posted

August 16, 2021

Study Start

June 12, 2021

Primary Completion

June 12, 2022

Study Completion

June 12, 2023

Last Updated

August 16, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol (Benedetta Isani)Access

Locations

IT(1)