Effects of Aerobic Exercise in Patients With Post COVID-19

NCT ID: NCT05231408

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-25
• Study Completion Date: 2025-01-15

Brief Summary

Many structures and organs are adversely affected after COVID-19. The most obvious and common problem is lung involvement. In the pathology report of the patients, it has been shown that there are changes such as diffuse alveolar damage, bronchiolitis and interstitial fibrosis. The most prominent effect of COVID-19 in patients with reduced lung functions is reduced diffusion capacity. While the disease severity worsens, pulmonary fibrosis becomes more pronounced in cases. The complaints of dyspnea and fatigue of patients after discharged continue. Inspiratory and expiratory respiratory muscle weakness are observed in more than 50% of patients with COVID-19, measured in the first month after the discharged. This respiratory muscle weakness is associated with myopathy due to hypoxemia, oxygen support, prolonged bed rest and corticosteroid use, regardless of disease severity.

It is seen that these patients with COVID-19 need exercise training because of lung involvement, decreased exercise capacity and persistence of some symptom complaints after the discharged.

Detailed Description

Patients with COVID-19 have not only reduced respiratory capacity, but also diminished muscle strength, exercise capacity, weakness cardiac system. In parallel with aforementioned, physical activity level and quality of life get worse in this patients. Therefore, the patients with COVID-19 need exercise training after the discharged. In the literature, the achievement of exercise training in many aspects such as exercise capacity, lung health, respiratory muscle strength, dyspnea has been proven in many diseases such as chronic obstructive pulmonary disease and heart failure.

Effects of high-intensity interval aerobic exercise training on oxygen consumption, muscle oxygenation, physical activity level, pulmonary function, functional exercise capacity, respiratory and peripheral strength, inspiratory muscle endurance, functional status, dyspnea, fatigue perception and quality of life have not been investigated in literature in patients with COVID-19. According to inclusion and exclusion criteria, 15 patients for training group and 15 patients for control group will be included. All assessments will be completed in two days before and after eight weeks training.

Primary outcome measurement will be oxygen consumption (cardiopulmonary exercise test).

Secondary outcome will be muscle oxygenation (Moxy device), physical activity level (multi sensor activity device), pulmonary function (spirometer), functional exercise capacity (six-minute walk test), respiratory (mouth pressure device) and peripheral muscle (hand-held dynamometer) strength, inspiratory muscle endurance (incremental threshold loading test), functional status (Post-COVID-19 Functional Status Scale), dyspnea (London Chest Daily Living Activity Scale), fatigue (Fatigue Severity Scale) and quality of life (Saint George Respiratory Questionnaire).

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Training Group

Training group will receive high-intensity interval aerobic exercise training on treadmill accompanied by physiotherapist for 8 weeks.

Group Type: EXPERIMENTAL

High-intensity interval aerobic exercise training

Intervention Type: OTHER

High-intensity interval aerobic exercise training will be given to training group on treadmill 3 days in a week and 15-45 minutes in a day for 8 weeks with the assistance of a physiotherapist.

The training workload of the active phase of high-intensity interval aerobic exercise training will be applied at 80-100% of peak oxygen consumption or 85-95% of peak heart rate or according to Borg scale dyspnea/fatigue 15-18 points.

The training workload of the active recovery phase of high-intensity interval aerobic exercise training will be applied at 50-60% of peak oxygen consumption or 60-75% of peak heart rate or according to Borg scale dyspnea/fatigue 11-13 points.

Control Group

Breathing exercises will be given to control group as a home program for 8 weeks.

Group Type: SHAM_COMPARATOR

Control Group

Intervention Type: OTHER

Breathing exercises will be given to the control group 120 times in a day and 7 days in a week for 8 weeks as a home program. The control group will be followed-up by telephone once a week.

Interventions

High-intensity interval aerobic exercise training

High-intensity interval aerobic exercise training will be given to training group on treadmill 3 days in a week and 15-45 minutes in a day for 8 weeks with the assistance of a physiotherapist.

The training workload of the active phase of high-intensity interval aerobic exercise training will be applied at 80-100% of peak oxygen consumption or 85-95% of peak heart rate or according to Borg scale dyspnea/fatigue 15-18 points.

The training workload of the active recovery phase of high-intensity interval aerobic exercise training will be applied at 50-60% of peak oxygen consumption or 60-75% of peak heart rate or according to Borg scale dyspnea/fatigue 11-13 points.

Intervention Type: OTHER

Control Group

Breathing exercises will be given to the control group 120 times in a day and 7 days in a week for 8 weeks as a home program. The control group will be followed-up by telephone once a week.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• aged between 18-75 years
• diagnosed with COVID-19 before
• patients whose COVID-19 Polymerase Chain Reaction test turned negative or be negative already
• patients who are willing to participate in this study

Exclusion Criteria

Patients with

• body mass index >35 kg/m2
• cancer, renal or hepatic diseases
• aortic stenosis, complex arrhythmia, aortic aneurysm
• serious neurological, neuromuscular, orthopedic, other systemic diseases or other diseases affecting physical functions
• uncontrolled hypertension and/or diabetes mellitus, heart failure and cardiovascular disease
• acute pulmonary exacerbation, acute upper or lower respiratory tract infection
• cognitive impairment that causes difficulty in understanding and following exercise test instructions
• bulla formation in the lung
• participated in a planned exercise program in the last three months
• contraindication for exercise testing and/or exercise training according to the American College of Sports Medicine

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Meral Boşnak Güçlü

Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ece BAYTOK, MsC

Role: STUDY_CHAIR

Gazi University

Başak Kavalcı KOL, MsC

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Nilgün Yılmaz DEMİRCİ, Assoc.Prof

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Meral Boşnak GÜÇLÜ, Prof. Dr

Role: STUDY_DIRECTOR

Gazi University

Locations

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Meral Boşnak GÜÇLÜ, Prof. Dr

Role: CONTACT

meralbosnak@gazi.edu.tr

+903122162647

Ece BAYTOK, MsC

Role: CONTACT

ecebaytok@gazi.edu.tr

+903122162647

Facility Contacts

Meral Boşnak GÜÇLÜ, Prof. Dr

Role: primary

meralbosnak@gazi.edu.tr

+903122162647

Ece BAYTOK, MsC

Role: backup

ecebaytok@gazi.edu.tr

+903122162647

References

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Reference Type: RESULT

PMID: 32172546 (View on PubMed)

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

PMID: 33490928 (View on PubMed)

Other Identifiers

Gazi University 90

Identifier Type: -

Identifier Source: org_study_id