CClinicalTrials.gg
Status unknownNCT04642040Updated Nov 24, 2020

Effectiveness of Pulmonary Rehabilitation Program in Patients With SARS-CoV-2 Pneumonia

An interventional study of Pulmonary Rehabilitation in Covid19, Covid19 Pneumonia and SARS-CoV 2 Pneumonia, sponsored by Sisli Hamidiye Etfal Training and Research Hospital. Status unknown at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-24.

Sponsored by Sisli Hamidiye Etfal Training and Research Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jun 2020, registered Nov 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the study is to investigate the efficacy of pulmonary rehabilitation (PR) program to patients with Sars-CoV-2 pneumonia in the post-acute period on pulmonary functions, exercise capacity and anxiety level.

100 patients diagnosed with Sars-CoV-2 pneumonia will be enrolled in this prospective, interventional study according to inclusion/exclusion criteria. Patients will be evaluated and a personalized PR program will be organized before hospital discharge. After discharge, the pulmonary rehabilitation program will continue in telerehabilitation.

In the telerehabilitation program, exercises will be supervised by a physiotherapist two days a week, and patients will be asked to do the exercises themselves for the other 3 days. Patients will also receive exercise videos for these 3 days.

Patients will be followed for 4 weeks and will be called for final evaluation

02

Conditions studied

  • Covid19
  • Covid19 Pneumonia
  • SARS-CoV 2 Pneumonia
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital is the lead sponsor of 110 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Pneumonia without having severe findings or a need for oxygen support therapy (mild pneumonia) accompanying special conditions (chronic lung / heart disease / diabetes / hypertension / neuromuscular disease history / elderly / immobility etc.)
  • Severe pneumonia (A suspicion of fever or respiratory tract infection and having one accompanying finding: respiration rate >30/min; severe respiratory distress; or SpO2 ≤93% in ambient air.) cases after they get clinically stable (decreased fever, reduced dyspnea, respiratory rate 90%)
  • At least 7 days since the diagnosis of SARS-CoV-2 in order to reduce the viral load and the risk of transmission
  • Being able to make video calls for telerehabilitation

Exclusion criteria

Exclusion Criteria:

  • Serious cardiovascular, cerebrovascular, neuromuscular and other systemic diseases that affect physical activity
  • Psychiatric illness and cognitive deficit that will affect patient's exercise cooperation
  • Pregnancy
  • The deterioration in the general condition of the patient, worsening of the lung findings
  • Acute respiratory distress syndrome
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Pulmonary Rehabilitation

    Patients are included in a personalized pulmonary telerehabilitation program consisting of patient education, respiratory and peripheral muscle training, and breathing strategies for 4 weeks. In the telerehabilitation program, exercises will be supervised by a physiotherapist two days a week, and patients will be asked to do the exercises themselves for the other 3 days. Patients will also receive instructional exercise videos for these 3 days.

    Other: Pulmonary Rehabilitation

Interventions

  • OtherPulmonary Rehabilitation

    Positioning,breathing techniques (diaphragmatic breathing, alternate breathing, and pursed-lip breathing),respiratory muscle exercises, joint ROM exercises, early-mobilization and progressive ambulation, peripheral muscle strengthening exercises

06

What researchers measure

Primary outcomes

  1. Change in Dyspnea level as measured by modified Medical Research Council (mMRC) Dyspnea Scale

    The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4. 0: no breathlessness except on strenuous exercise; 4: too breathless to leave the house, or breathless when dressing or undressing.

    Time frame: 4 weeks

  2. Change in functional capacity as measured by 30-second sit-to-stand test

    30 sec- STS determines lower extremity strength and physical fitness in older adults. The number of repetitions is recorded.

    Time frame: 4 weeks

Secondary outcomes

  1. Change in physical activity level as measured by International Physical Activity Questionnaire (IPAQ) -Short Form

    IPAQ-Short Form is used to measure level of physical activity.It consists of 7 questions that provide information about time spent on walking, moderate to vigorous physical activities, and time spent sitting. The energy required for the activities was calculated by the MET-minute/week score. Standard MET values for these activities are: Walking = 3,3 METS; Moderate Physical Activity = 4,0 METS; Vigorous Physical Activity = 8.0 METS; Sitting = 1,5 METS

    Time frame: 4 weeks

  2. Change in anxiety and depression as measured by Hospital Anxiety and Depression Scale (HADS)

    HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression.The total scores range is 0-21 for both depression and anxiety scores. A higher score indicates a worse depression and anxiety.

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Sisli Hamidiye Etfal Training and Research Hospital
    Istanbul, 34371, Turkey
    • Enes Efe Is, MD · Contact · enefeis@gmail.com · +902123735000
    • Ali Sahillioglu, MD · Principal investigator
    Recruiting
08

References and documents

Publications

  • Kurtais Aytur Y, Koseoglu BF, Ozyemisci Taskiran O, Ordu-Gokkaya NK, Unsal Delialioglu S, Sonel Tur B, Sarikaya S, Sirzai H, Tekdemir Tiftik T, Alemdaroglu E, Ayhan FF, Duyur Cakit BD, Genc A, Gundogdu I, Guzel R, Demirbag Karayel D, Bilir Kaya B, Oken O, Ozdemir H, Soyupek F, Tikiz C. Pulmonary rehabilitation principles in SARS-COV-2 infection (COVID-19): A guideline for the acute and subacute rehabilitation. Turk J Phys Med Rehabil. 2020 May 12;66(2):104-120. doi: 10.5606/tftrd.2020.6444. eCollection 2020 Jun. PubMed 32760887 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04642040
Lead sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Responsible party
Enes Efe Is (MD, Sisli Hamidiye Etfal Training and Research Hospital) — Principal investigator
First posted
Nov 24, 2020
Start date
Jun 30, 2020
Primary completion
Jan 2021 (estimated)
Completion
Jan 2021 (estimated)
Last update
Nov 24, 2020

Study contacts

Enes Efe Is, MD
Contact
enefeis@gmail.com
+902123735000
Ali Sahillioglu, MD
principal investigator · Sisli Hamidiye Etfal Training and Research Hospital PMR Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion