Completed

Is Tele-rehabilitation Superior to Home Exercise Program in the Pulmonary Rehabilitation of the Patients With COVID-19 With Post-intensive Care Syndrome? A Randomized Controlled Trial

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What is being tested

Remote controlled exercise

+ Home exercise

Other
Who is being recruted

COVID-19+9

+ Coronaviridae Infections

+ Infections

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2020
See protocol details

Summary

Principal SponsorKoç University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2020

Actual date on which the first participant was enrolled.

COVID-19 could cause respiratory distress in a minority of cases and requires intensive care and mechanical ventilation. When patients recover and are discharged from hospital, physical, cognitive and emotional complications known as post-intensive care syndrome is seen in the majority of patients and requires rehabilitation. Pulmonary rehabilitation is a comprehensive intervention consists of assessment of patient, exercise training and education in order to improve physical and psychological condition of people with chronic respiratory disease. The patients with COVID-19 with post-intensive care syndrome will be randomized two groups: Tele-rehabilitation group and home exercise group. There will not be a non-exercising control group due to the ethical issues. The exercise program of both groups will be prescribed by a physiatrist based on the physical examination and the functional capacity of the patients. Tele-rehabilitation group will perform the exercise program 3 days/week for 10 weeks. One session will include aerobic, flexibility and strengthening exercises for lower and upper extremity and breathing exercise. The trainings will start with low-intensity exercises and intensity and duration of the exercises will progress according to the condition of the patient. Intensity of the exercises will be monitored by Borg scale based on dyspnea and exertion symptoms during the sessions. Home exercise group will perform the exercises at their home on their own, 3 days/week for 10 weeks. The patients will be trained about the individualised exercise program as the first session provided at the hospital. The physiotherapist will call the patients weekly, modifications in the exercise program will be made according to the patient's reports. Outcomes will be measured at baseline, within 1 week of completion the program, 6th months and 12th months following the rehabilitation.

Official TitleIs Tele-rehabilitation Superior to Home Exercise Program in the Pulmonary Rehabilitation of the Patients With COVID-19 With Post-intensive Care Syndrome? A Randomized Controlled Trial
NCT04482634
Principal SponsorKoç University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

122 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

COVID-19Coronaviridae InfectionsInfectionsLung DiseasesPneumoniaPneumonia, ViralRespiratory Tract DiseasesRespiratory Tract InfectionsRNA Virus InfectionsVirus DiseasesCoronavirus InfectionsNidovirales Infections

Criteria

3 inclusion criteria required to participate
To be older than 18 years

To be discharged from ICU with a diagnosis of ARDS or severe pneumonia due to COVID-19

To have ability to walk independently

2 exclusion criteria prevent from participating
To have dementia or cognitive impairment, symptomatic psychiatric illness, hearing or visual impairment that might interfere to follow the instructions

To have a severe co-morbidity that exercise is contraindicated

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
This group will perform the exercises at their home under remote supervision of a physiotherapist via internet connection.

Group II

Active Comparator
This group will perform the exercises at their home on their own, the first exercise program will be given at hospital and the patients will be followed up regular weekly by phone call.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Koc University School of Medicine

Istanbul, Turkey (Türkiye)Open Koc University School of Medicine in Google Maps
CompletedOne Study Center