NCT05231408

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

February 25, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

2.5 years

First QC Date

February 8, 2022

Last Update Submit

February 3, 2024

Conditions

COVID-19

Keywords

COVID-19aerobic exercise trainingmuscle oxygenationoxygen consumptionphysical activity

Outcome Measures

Primary Outcomes (1)

  • Oxygen consumption

    Maximal exercise capacity will be assessed with symptom limited cardiopulmonary exercise test on a treadmill at a progressively increasing speed and grade. Oxygen consumption will be measured during the test.

    First day

Secondary Outcomes (13)

  • Muscle Oxygenation

    First and second day

  • Physical activity level

    Second day

  • Pulmonary function

    Second day

  • Functional exercise capacity

    Second day

  • Respiratory muscle strength

    Second day

  • +8 more secondary outcomes

Study Arms (2)

Training Group

EXPERIMENTAL

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

Other: High-intensity interval aerobic exercise training

Control Group

SHAM COMPARATOR

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

Other: Control Group

Interventions

High-intensity interval aerobic exercise trainingOTHER

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.

Training Group
Control GroupOTHER

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.

Control Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • Yao XH, Li TY, He ZC, Ping YF, Liu HW, Yu SC, Mou HM, Wang LH, Zhang HR, Fu WJ, Luo T, Liu F, Guo QN, Chen C, Xiao HL, Guo HT, Lin S, Xiang DF, Shi Y, Pan GQ, Li QR, Huang X, Cui Y, Liu XZ, Tang W, Pan PF, Huang XQ, Ding YQ, Bian XW. [A pathological report of three COVID-19 cases by minimal invasive autopsies]. Zhonghua Bing Li Xue Za Zhi. 2020 May 8;49(5):411-417. doi: 10.3760/cma.j.cn112151-20200312-00193. Chinese.

    PMID: 32172546RESULT

  • You J, Zhang L, Ni-Jia-Ti MY, Zhang J, Hu F, Chen L, Dong Y, Yang K, Zhang B, Zhang S. Anormal pulmonary function and residual CT abnormalities in rehabilitating COVID-19 patients after discharge. J Infect. 2020 Aug;81(2):e150-e152. doi: 10.1016/j.jinf.2020.06.003. Epub 2020 Jun 5. No abstract available.

    PMID: 32512021RESULT

  • Huang Y, Tan C, Wu J, Chen M, Wang Z, Luo L, Zhou X, Liu X, Huang X, Yuan S, Chen C, Gao F, Huang J, Shan H, Liu J. Impact of coronavirus disease 2019 on pulmonary function in early convalescence phase. Respir Res. 2020 Jun 29;21(1):163. doi: 10.1186/s12931-020-01429-6.

    PMID: 32600344RESULT

  • Mo X, Jian W, Su Z, Chen M, Peng H, Peng P, Lei C, Chen R, Zhong N, Li S. Abnormal pulmonary function in COVID-19 patients at time of hospital discharge. Eur Respir J. 2020 Jun 18;55(6):2001217. doi: 10.1183/13993003.01217-2020. Print 2020 Jun.

    PMID: 32381497RESULT

  • Raman B, Cassar MP, Tunnicliffe EM, Filippini N, Griffanti L, Alfaro-Almagro F, Okell T, Sheerin F, Xie C, Mahmod M, Mozes FE, Lewandowski AJ, Ohuma EO, Holdsworth D, Lamlum H, Woodman MJ, Krasopoulos C, Mills R, McConnell FAK, Wang C, Arthofer C, Lange FJ, Andersson J, Jenkinson M, Antoniades C, Channon KM, Shanmuganathan M, Ferreira VM, Piechnik SK, Klenerman P, Brightling C, Talbot NP, Petousi N, Rahman NM, Ho LP, Saunders K, Geddes JR, Harrison PJ, Pattinson K, Rowland MJ, Angus BJ, Gleeson F, Pavlides M, Koychev I, Miller KL, Mackay C, Jezzard P, Smith SM, Neubauer S. Medium-term effects of SARS-CoV-2 infection on multiple vital organs, exercise capacity, cognition, quality of life and mental health, post-hospital discharge. EClinicalMedicine. 2021 Jan 7;31:100683. doi: 10.1016/j.eclinm.2020.100683. eCollection 2021 Jan.

    PMID: 33490928RESULT

MeSH Terms

Conditions

COVID-19Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ece BAYTOK, MsC

    Gazi University

    STUDY CHAIR

  • Başak Kavalcı KOL, MsC

    Gazi University

    PRINCIPAL INVESTIGATOR

  • Nilgün Yılmaz DEMİRCİ, Assoc.Prof

    Gazi University

    PRINCIPAL INVESTIGATOR

  • Meral Boşnak GÜÇLÜ, Prof. Dr

    Gazi University

    STUDY DIRECTOR

Central Study Contacts

Meral Boşnak GÜÇLÜ, Prof. Dr

CONTACT

+903122162647meralbosnak@gazi.edu.tr

Ece BAYTOK, MsC

CONTACT

+903122162647ecebaytok@gazi.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Triple-blind study; the patients will not be informed about their groups (training group or the control group) and they will be evaluated and trained at different places and times. Evaluations and interventions will be performed different physiotherapist. In addition, before statistical analysis patients' groups will be coded.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic

Study Record Dates

First Submitted

February 8, 2022

First Posted

February 9, 2022

Study Start

February 25, 2022

Primary Completion

August 15, 2024

Study Completion

January 15, 2025

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)