Efficacy of Synchronous and Asynchronous Telerehabilitation in COVID-19 Discharges

COVID-19 Clinical Trial

Official title:

Efficacy of Synchronous and Asynchronous Telerehabilitation in COVID-19 Discharges

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05205434
• Other study ID #: BitlisErenU2
• Status: Completed
• Phase: N/A
• Start date: September 25, 2021
• Est. completion date: September 7, 2022

Study information

• Verified date: March 2023
• Source: Bitlis Eren University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators aimed to evaluate the effectiveness of exercise programs given by synchronous and asynchronous telerehabilitation methods in patients after discharge from COVID-19.

Description:

Fifty seven participants will be enrolled. Participants will be randomly divided into 3 groups.

For this purpose, patients will be recruited at the time of discharge from the hospital and two experimental groups with the same physical therapy and educational program will be carried out. participants in the control group will only educational program. Participants in experimental groups will be followed using videoconference interviews from synchronous telerehabilitation methods and mobile application from asynchronous telerehabilitation methods at home. These participants will be given an 8-week exercise program. The exercise program will consist of physical exercises (aerobic and strength exercises) along with breathing exercises and the patients will be evaluated before and after the treatment.

After treatment programs, the functional capacity, performance, and hemodynamic parameters of the participants will be evaluated. Quality of life, physical activity level, anxiety-depression, and fatigue severity will also be evaluated with questionnaires.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 7, 2022
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• COVID-19 patients in the subacute period discharged

• Be 18 years or older

• Having received oxygen therapy or mechanical ventilation support in the hospital

• Access to online interviews and web-based exercises with a secure internet connection

• Having sufficient speaking and hearing skills for telerehabilitation

• Volunteer to participate in research

Exclusion Criteria:

• Unstable clinical condition

• Having had cerebrovascular disease, intra-articular drug injection or surgery of the lower extremities in the last 6 months

• Inability to walk independently, even with an assistive device

• Having serious neuromuscular problems

• Not being cooperative enough to answer and understand questionnaires and scales

Related Conditions & MeSH terms

• COVID-19
• Telerehabilitation

Intervention

Other:
• Synchronous telerehabilitation programme
Exercise program and educational program
• Asynchronous telerehabilitation programme
Exercise program educational program

Locations

Country	Name	City	State
Turkey	Marmara University	Maltepe	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Bitlis Eren University	Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oxygen Saturation and Heart Rate	Participants' resting oxygen saturation and heart rate, and oxygen saturation and heart rate after the tests will be evaluated	Change from baseline oxygen saturation (SaO2) and heart rate (beats per minute) of the patients at the end of the 8th week and, postintervation sixth months
Other	Dyspnea and Fatigue Level	Participants' dyspnea and fatigue level, and dyspnea and fatigue level after the tests will be evaluated according to the Modified Borg (0-10) scale	Change from baseline dyspnea and fatigue of the patients at the end of the 8th week and, postintervation sixth months
Other	Timed Up-Go Test (TUG)	Participants are asked to get up from the chair, walk 3 m at a comfortable and safe pace, return and sit back in the chair.	Change from baseline time (second) of the patients at the end of the 8th week and, postintervation sixth months
Other	International Physical Activity Questionnaire Short Form (IPAQ)	It is a scale used to determine the level of physical activity in adults. The scale questions vigorous and moderate physical activity, walking time of at least 10 minutes and daily sitting time in the last 7 days.	Change from baseline metabolic equivalent (MET)-minute/week of the patients at the end of the 8th week and, postintervation sixth months
Other	Hospital Anxiety Depression (HAD) Scale	The questionnaire, which was filled in by the patient and includes the anxiety and depression subscales, consists of 14 items. Responses are scored between 0-3.	Change from baseline score in scale of the patients at the end of the 8th week and, postintervation sixth months
Other	Fatigue Severity Scale	This scale is a 9-item scale that measures the severity of fatigue in patients and its effect on one's activities and lifestyle. Responses are scored on a seven-point scale with 1 = strongly disagree and 7 = strongly agree.	Change from baseline score in scale of the patients at the end of the 8th week and, postintervation sixth months
Other	Quality of Life Scale: Short Form-36 (SF-36)	The self-assessment scale consists of 36 items and 8 sub-dimensions. The scale is evaluated considering the last four weeks. On the scale, 0 points indicate poor health and 100 points indicate good health.	Change from baseline score in scale of the patients at the end of the 8th week and, postintervation sixth months
Primary	Incremental Shuttle Walk Test (ISWT)	The participant will be asked to walk around two 9-meter cones and complete them within the given time. Oxygen saturation and heart rate will be measured before and immediately after the test. They will be asked to self-report dyspnea and fatigue according to the modified Borg scale (0-10).	Change from baseline walking distance (meters) of the patients at the end of the 8th week and, postintervation sixth months
Secondary	30-Second Chair Stand Test (30 CST)	The patient will be asked to sit and stand as much as possible within 30 seconds, with his hands crossed over his chest. The number of sitting and staying for 30 seconds will be noted.	Change from baseline number of sitting and staying of the patients at the end of the 8th week and, postintervation sixth months
Secondary	Brief Physical Performance Battery (BPPB)	It is a test used to evaluate the lower extremity function of patients. This battery represents the sum of 3 functional tests such as standing stance tests, 4 meters walking test and 5 times chair sit and stand (5STS). Each test is scored between 0 (not completing the test) and 4 (highest performance level)	Change from baseline score of the patients at the end of the 8th week and, postintervation sixth months