NCT05739032

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

1.2 years

First QC Date

February 21, 2023

Last Update Submit

January 11, 2024

Conditions

Keywords

post-COVID-19Lung functionFatigueAerobic exerciseStrength training

Outcome Measures

Primary Outcomes (1)

  • Six Minute Walk Test Distance

    six minute

Study Arms (2)

Exercise group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Control group continued only routine follow-up.

Interventions

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.

Exercise group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuh Naci Yazgan University

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Interventions

ExerciseResistance Training

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 21, 2023

First Posted

February 22, 2023

Study Start

March 5, 2021

Primary Completion

May 30, 2022

Study Completion

October 30, 2022

Last Updated

January 16, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

send via mail

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
two years

Locations