Clinical trial NCT04482634: Tele-rehabilitation Versus Home Exercise Program in COVID-19
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Rehabilitation
COVID-19
Keywords: pulmonary rehabilitation
COVID-19
pulmonary exercise
post-intensive care syndrome
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two groups. The first group will perform the exercises at their home under remote supervision (tele-rehabilitation group) and the second group will perform the exercises at their home on their own (home exercise group)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 6-minute walk test
timeFrame: 12 months
Secondary outcomes:
measure: Short form - 36
timeFrame: 12 months
measure: Chair- stand test
timeFrame: 12 months
measure: Timed up and go test
timeFrame: 12 months
measure: St. George's Respiratory Questionnaire
timeFrame: 12 months
measure: The COPD Assessment Test
timeFrame: 12 months
measure: Medical Research Council Dyspnea Scale
timeFrame: 12 months
measure: Hand grip strength
timeFrame: 12 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University School of Medicine
Study officials:
affiliation: Koc University School of Medicine
name: Ozden Ozyemisci Taskiran, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Turan Z, Ozyemisci Taskiran O, Erden Z, Kokturk N, Kaymak Karatas G. Does hand grip strength decrease in chronic obstructive pulmonary disease exacerbation? A cross-sectional study. Turk J Med Sci. 2019 Jun 18;49(3):802-808. doi: 10.3906/sag-1811-22.
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