The Effect of Aerobic Exercise on Immune Biomarkers and Symptoms Severity and Progression in Patients With COVID-19: A Pilot Randomized Control Trial
1 other identifier
interventional
30
1 country
1
Brief Summary
Participants were assigned randomly into two groups, exercise and control groups. All participants in both groups followed the WHO guidelines of quarantine and used standardized medications given by the physician according to the Turkish Ministry of Health guidelines, including the Hydroxyclorocin Sulphate 200 Mg Film Tablet (Plaquenil 200 Mg Film Tablet). The dose was 2 times/ day, 200Mg/time, for 5 days. Besides, the exercise group performed moderate-intensity aerobic exercises for 40 min/ 3 sessions/week, 40 minute/session.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable covid19
Started Jan 2020
1 active site
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
Study Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 4, 2020
CompletedFirst Posted
Study publicly available on registry
October 9, 2020
CompletedOctober 9, 2020
October 1, 2020
5 months
October 4, 2020
October 7, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Immune system markers
A blood was centrifuged at 3,000 rpm for 15 min at 4◦C. We measured total lymphocytes, leukocytes, and monocytes from total-blood samples utilizing a multichannel hemocyte analysis system (SE-9000; Sysmex Corp, Hyogo, Japan). A saliva sample was collected to measure the salivary IgA-S concentration.
4 Months
Upper respiratory tract infection symptoms severity and progression
The Wisconsin Upper Respiratory Symptom Survey (WURSS) is an empirically derived patient-oriented illness-specific quality-of-life evaluative outcomes instrument. The development process of this survey was described in detail by Barrett et al. WURSS-24 is designed to evaluate the negative effect of acute upper respiratory infection, presumed viral (the common cold). Its a valid and reliable measurement tool to evaluate the measure items and domains that change over time including influenza-like illness symptoms of headache, body aches, and fever. The participants were asked to fill the survey before starting the study and the 2 times/week.
4 Months
Study Arms (2)
Intervention group
EXPERIMENTALControl group
EXPERIMENTALInterventions
Participants in the exercise group performed a two weeks aerobic exercise program. The exercise program consisted of walking/running on a treadmill or bicycling on a stationary bicycle. Each session is composed of five-minute warm-up slow walking or bicycling. Then the main intervention which composed of thirty-minutes of moderate-intensity aerobic exercises (walking/running or bicycling). Lastly, a five-minute of cool-down exercises (walking/running or bicycling). The exercise intensity was 60-75% of the predicted MHR (calculated as MHR=210-age).
Eligibility Criteria
You may qualify if:
- the patient has a recent mild or moderate COVID-19 with no or low-grade fever 99.5- 100.94 °F (37.5-38.3 °C). Mild COVID-19 included that the patient has symptoms of acute upper respiratory tract infection (fever, cough, myalgia, runny nose, fatigue, sore throat, sneezing) or gastrointestinal symptoms (nausea, vomiting, abdominal pain, diarrhea). Moderate grade of COVID 19 included that the participant has pneumonia (cough, frequent fever) with no obvious hypoxemia, the presence of lesions on chest CT
You may not qualify if:
- that patient was not hospitalized and has moderate or high-grade fever \<100.94 °F (\<38.3 °C) or other chronic diseases such as heart problems, hypertension or diabetes. Women how were using contraceptives were excluded due to contraceptives decrease immune functions and might affect the subjectivity to autoimmune disorders with marked increases in risk for various autoimmune disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Motaz Alawna
Istanbul, 3, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor (Principal Investigator)
Study Record Dates
First Submitted
October 4, 2020
First Posted
October 9, 2020
Study Start
January 1, 2020
Primary Completion
June 1, 2020
Study Completion
October 1, 2020
Last Updated
October 9, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share