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Tele-rehabilitation Versus Home Exercise Program in COVID-19

K

Koç University

Status

Completed

Conditions

COVID-19
Pulmonary Rehabilitation

Treatments

Other: Home exercise
Other: Remote controlled exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT04482634
2020.219.IRB1.069

Details and patient eligibility

About

The aim of the study is to investigate the potential effects of face-to-face supervised tele-rehabilitation to home exercise program on walking speed, handgrip strength, muscle endurance, quality of life, physical activity level and perceived respiratory disability in COVID-19 patients who hospitalized in ICU due to ARDS and discharged from hospital.

Full description

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.

Enrollment

122 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

122 participants in 2 patient groups

Tele-rehabilitation group
Active Comparator group
Description:
This group will perform the exercises at their home under remote supervision of a physiotherapist via internet connection.
Treatment:
Other: Remote controlled exercise
Home exercise group
Active Comparator group
Description:
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.
Treatment:
Other: Home exercise

Trial contacts and locations

1

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Central trial contact

Baris Ata, Prof; Ihsan Solaroglu, Prof

Data sourced from clinicaltrials.gov

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