NCT04581291

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

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Jan 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
Last Updated

October 9, 2020

Status Verified

October 1, 2020

Enrollment Period

5 months

First QC Date

October 4, 2020

Last Update Submit

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

EXPERIMENTAL
Other: Moderate Intensity Aerobic Exercises

Control group

EXPERIMENTAL
Other: Moderate Intensity Aerobic Exercises

Interventions

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).

Control groupIntervention group

Eligibility Criteria

Age24 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

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

Locations