Comparison of Pulmonary Telerehabilitation and Physical Activity Recommendations in Patients With Post Covid Fibrosis

COVID-19 Clinical Trial

Official title:

Comparison of the Effectiveness of Pulmonary Telerehabilitation and Physical Activity Recommendations in Patients With Pulmonary Fibrosis Due to COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05299333
• Other study ID #: 2022/25
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2022
• Est. completion date: June 7, 2024

Study information

• Verified date: February 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Ozge Ertan, Msc
• Phone: +902124141500
• Email: ozge.ertann[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rehabilitation plays a very important role in the management of patients with COVID-19, focusing on respiratory and motor functions, and therefore the importance of establishing treatment strategies to ensure optimal recovery of these patients has been emphasized. It has been stated that physical activity recommendations should be clarified for the management of symptoms associated with prolonged COVID-19 Syndrome and for the continuation of activities of daily living. It has been stated that after COVID-19 pneumonia, it is necessary to evaluate the physical functions of patients with long-term follow-up and to establish rehabilitation programs. The importance of being included in the rehabilitation program was emphasized, especially for patients with lung fibrosis.

The primary aim of this study was to compare the effects of pulmonary telerehabilitation and physical activity recommendations on exercise capacity and peripheral muscle strength in patients with pulmonary fibrosis due to COVID-19.

The secondary aim of this study is to compare the effects of pulmonary telerehabilitation and physical activity recommendations on symptoms, activity and participation in patients with pulmonary fibrosis due to COVID-19.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 7, 2024
• Est. primary completion date: June 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• >18 years old

• Patients who have been infected with the COVID-19 virus at least three months ago and have been diagnosed with a positive PCR

• Patients with post-COVID-19 pulmonary fibrosis followed by a pulmonologist

• Patients who have sufficient technological infrastructure to participate in the telerehabilitation program and can adapt to online systems

• Patients who are clinically stable

Exclusion Criteria:

• Patients with orthopedic/neurological problems that prevent walking and exercise

• Patients with uncontrolled cardiovascular disease

• Patients with uncontrolled medical conditions

Related Conditions & MeSH terms

• COVID-19
• Fibrosis
• Pulmonary Fibrosis

Intervention

Other:
• Exercise
High repetition muscle endurance and strengthening exercises Walking

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Submaximal exercise capacity	Six minute walk test and	1 week-8 week
Primary	maximal exercise capacity	Incremental shuttle walk test	1 week-8 week
Primary	endurance exercise capacity	endurance shuttle walk test	1 week-8 week
Primary	Peripheral muscle strength	Hand-held dynamometer	1 week-8 week
Secondary	Physical activity	Pedometer and activity monitor	1 week-8 week
Secondary	Dyspnea	Modified Medical Research Council Dyspnea Scale stratifies severity of dyspnea in respiratory diseases	1 week-8 week
Secondary	Fatigue	Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue. FSS contains nine statements that rate the severity of your fatigue symptoms. A low value indicates strong disagreement with the statement, whereas a high value indicates strong agreement.	1 week-8 week
Secondary	Physical fitness	1 min sit to stand test	1 week-8 week
Secondary	Functionality	Post covid-19 functionality scale (PCFS): The PCFS scale stratifies functional status limitation as follows: grade 0 (No functional limitations), grade 1 (Negligible functional limitations), grade 2 (Slight functional limitations), grade 3 (Moderate functional limitations), grade 4 (Severe functional limitations), and grade 5 (death)	1 week-8 week
Secondary	System usability	System usability scale	8 week
Secondary	Emotional status	Hospital anxiety and depression scale	1 week-8 week
Secondary	Body composition	Bioelectrical impedence analysis	1 week-8 week
Secondary	Activities of daily living	London chest activity of daily living scale: Perceived dyspnea while performing daily living activities is scored between 0-5. A high score indicates greater disability in performing ADLs. The minimum score 0 and maximum total score is 75.	1 week-8 week