Exercise Training Six-Months After Discharge in Post-COVID-19 Syndrome

Sponsor

Ukbe Sirayder (Other)

Overall Status

Completed

CT.gov ID

NCT05739032

Collaborator

(none)

Enrollment

Location

Arms

19.8

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study investigate the effects of 12-week exercise training on pulmonary function, symptoms, functional capacity, and quality of life (QoL) in patients with severe

COVID 6 months after intensive care discharge. The main question it aims to answer are:

1-Does exercise training given in post-COVID-19 syndrome have an effect on pulmonary function, symptoms, functional capacity, muscle strength and quality of life?

25 severe post-COVID patients (35 M) were in exercise group (EG) (age=52.9±11 years, 18M), and 25 (age=53.6±11.9 years, 17M) were in the control group (CG). EG received aerobic exercise (30-min walking) and upper and lower extremity strength training for 12 weeks for 3 days/week. CG continued only routine follow-up.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pneumonia	Other: Aerobic exercise and strength training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Exercise Training Six-Months After Discharge in Post-COVID-19 Syndrome: Randomized Controlled Trial

Actual Study Start Date :

Mar 5, 2021

Actual Primary Completion Date :

May 30, 2022

Actual Study Completion Date :

Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise group Exercise group received aerobic exercise (30-min walking) and upper and lower extremity strength training for 12 weeks for 3 days/week.	Other: Aerobic exercise and strength training Aerobic Exercise Training: The individuals in the study group were given aerobic exercise training at 70-80% of the 6MWT average speed. Patients performed exercise three days per week (twice under the supervision of a physiotherapist and once at home) for 30 minutes a day. Strength Training: Lower and upper extremity strengthening training was performed three days a week, 3x10-12 repetitions per day, with the help of a resistance band suitable for muscle strength. Hip flexion, hip abduction, knee flexion, and knee extension exercises for the lower extremity, and shoulder flexion, shoulder extension, shoulder abduction, shoulder elevation, external rotation, horizontal shoulder abduction, and scapular adduction exercises for the upper extremity were performed.
No Intervention: Control group Control group continued only routine follow-up.

Arm

Intervention/Treatment

Experimental: Exercise group

Exercise group received aerobic exercise (30-min walking) and upper and lower extremity strength training for 12 weeks for 3 days/week.

Other: Aerobic exercise and strength training

Aerobic Exercise Training: The individuals in the study group were given aerobic exercise training at 70-80% of the 6MWT average speed. Patients performed exercise three days per week (twice under the supervision of a physiotherapist and once at home) for 30 minutes a day. Strength Training: Lower and upper extremity strengthening training was performed three days a week, 3x10-12 repetitions per day, with the help of a resistance band suitable for muscle strength. Hip flexion, hip abduction, knee flexion, and knee extension exercises for the lower extremity, and shoulder flexion, shoulder extension, shoulder abduction, shoulder elevation, external rotation, horizontal shoulder abduction, and scapular adduction exercises for the upper extremity were performed.

No Intervention: Control group

Control group continued only routine follow-up.

Outcome Measures

Primary Outcome Measures

Six Minute Walk Test Distance [six minute]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

COVID-19 pneumonia patients were followed up for at least 24 h in the ICU. Those post-COVID six months who could cooperate with the tests and volunteered to participate were included.

Exclusion Criteria:

Individuals with pulmonary, orthopedic, neurological, vestibular, and psychological problems diagnosed before COVID-19 infection; myocarditis developed after COVID-19 infection; and those pregnant and those having any other acute diseases (such as infection and trauma) that would prevent performing the tests and/or interfering with the test results were excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nuh Naci Yazgan University	Kayseri		Turkey

Sponsors and Collaborators

Ukbe Sirayder

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ukbe Sirayder, USirayder, Nuh Naci Yazgan University

ClinicalTrials.gov Identifier:

NCT05739032

Other Study ID Numbers:

NNYUSİRAYDER1

First Posted:

Feb 22, 2023

Last Update Posted:

Feb 22, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ukbe Sirayder, USirayder, Nuh Naci Yazgan University

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Feb 22, 2023