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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Pneumonia
• Intervention / Treatment: Other: Aerobic exercise and strength training

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey
    • Nuh Naci Yazgan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Six Minute Walk Test Distance	six minute

Collaborators and Investigators

• Sponsor: Ukbe Sirayder

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Aerobic exercise; Fatigue; Lung function; Strength training; post-COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: NNYUSİRAYDER1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: send via mail
• IPD Sharing Time Frame: two years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No