StudyLTCovid.com

StudyLTCovid.com

Criteria for Inclusion in This Study

 

 

StudyLTCOVID.com

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There exists a great variablility, a wide spectrum, of what those with "long-term" COVID-19 experience on most days.

 

In very general terms, an individual became ill, and that illness has now lasted longer than expected. But to help people decide whether to seek enrollment in this study or not, the following will be of use. Almost no individual with this illness has experienced all that is presented below.

 

As you read on, and if a potential enrollee because you have "long term" COVID-19, see how much this sounds like your experience.

 

Our guide in this is our questionnaire responded to from last September to November of 2020.

This, fully reported at LTCOVID.com.

In many ways, responses obtained therein helped to define the natural history of this illness, or at least, as it presented at that point in time. Nothing says that new symptoms or a change in level of importance, can't manifest somewhat differently since then. At that time, many had first become ill in March of 2020, and something about the virus at that time, (its genetic makeup for example), may now have changed. The effect of vaccination for this viral illness was at that time hoped for but absent. Now it has become a reality. 

 

Since our prior work, other studies have suggested that the entity of "long-term" COVID-19 continues, independent of vaccination, and remains a specific and definable entity. Before deciding to group it with other illnesses felt to be similar, here we will carefully maintain focus on "long-term" COVID-19 and this study's specific findings.

 

We are enrolling 40 individuals in this present study.

 

Twenty (20) have a pre-illness record of significant frequent athletic activity. They are the "endurance athletes" arm of the study, abbreviated EA. They will help to demonstrate the important impact of "long-term" COVID-19 on even intact or "in shape" bodies. This is not an illness limited to those who were "out of shape" when becoming infected.

 

Twenty (20) others are suffering with "long-term" COVID-19, but are not athletes. They can in fact not be athletic at all. They are the present embodiment of those respondents surveyed last Fall. They are titled the "Not endurance-athletes" abbreviated NEA to identify those enrolled in this arm of the present study. Body composition data were obtained as part of the previous questionnaire.

While not used in the present study to set specific limits, these data give a sense of physical size that is of use in trying to match these "Not endurance-athletes" for the present study.

A simple summary is that marked overweight or underweight was associated with more problems when iinfected with SARS-CoV-2. Most respondents last Fall were overweight by established standards. More on this below.

 

GENDER

A majority in each arm of the study are female. Prior study: 90.37% women; 9.63% men.

So in each arm of this study of 20 individuals, that would give 18 women and 2 men. To help distinguish gender differences if they appear, we shift this to 15 women and 5 men in each study arm. That's a total of 30 women and 10 men studied. One aim of this shift is to identify gender differences in response to the intervention, if present. 

 

We will present a tally of enrollee gender on this site, so outreach to those still needed can be carried out. Of course as we begin, that tally is 0 women and 0 men enrolled! That will look like this next line, and will be updated here as enrollment proceeds.

 

June 5, 2021: 0/30 women & 0/10 men. 

 

 

RACE

Respondents to the aforementioned questionnaire were white 89% of the time. 

Using group comparisons, some significant differences were previously identified linked to race.

These have been presented halfway down on this page.

While of interest, their careful definition is not possible in a study of the present size.

 

While enrollee race will be noted, no specific targets based on race will be used in approaching enrollees for this study.

 

AGE

Mean age for questionnaire respondents was 48.19±10.90 years. 

Two standard deviations to either side gives a range of 26.4 to 69.9 years.

While this adds focus to the process of selecting enrollees, deciding to use "48 years old" as a criterion is not helpful. This may be expecially true for the endurance athlete arm.

Simply put, there are no age limitations for this present study.

 

BODY SIZE

Most in our prior survey were overweight. They also tended to be slightly taller than average.

While some were obese and others underweight, as mentioned both extremes can pose problems for those with COVID-19 infections, and be associated with a poor outcome. 

In this present study, Body Mass Index, though calculated and presented for subsequent analysis, will not be used to include nor exclude potential enrollees. 

 

The study does involve 4 periods on separate days of 6 minutes of very mild exercise (marching at a specific pace), and detailed elsewhere. If one's body size precludes even this usually unstrenuous effort, one should not seek enrollment. Being affected by "long-term" COVID-19 may change a "usually unstrenuous effort," to something quite challenging. This, even for previous endurance athletes. Each individual should give this careful consideration.

 

PRE-ILLNESS SOCIAL ROLE

This refers to married or single, breadwinner or homemaker, parent or not, and specific employment. These were discovered and presented here.

No specific targets based on pre-ilness social role are used in this study.

 

SMOKING HISTORY

While it seems evident that fewer smokers will be found in the endurance athlete arm of the study, 57% were non-smokers who responded last Fall, leaving a number of smokers greater than the 13% to 14% found in the populations concerned.

 

While not specifically seeking to enroll smokers only, smoking should not be taken as a reason for exclusion from this study.

 

MEDICATIONS & THERAPIES 

Use of presecribed medications, nutritional supplements or other (non-allopathic) therapies are not used as a criterion for inclusion or exclusion from this study.

 

ILLNESS SEVERITY

Respondents characterized their illness as "Moderate," in 82.35%. This is an illness in which the person stayed home but became very sick, had many symptoms, and that illness lasted longer than anticipated. 

 

Most (68.2%) respondents last Fall had not been hospitalized with this illness. 8.89% one day or less, and 9.63% more than one day.

Prior hospitalization is not an inclusion or exclusion criterion. It is assumed that anyone still in hospital will not be seeking enrollment. If the illness required recent hospitalization (in the last month for example), continuing convalescence and recovery takes precedence on participation in this study. This is especially true since the study includes 4 sessions of 6 minutes of exercise.

 

DIAGNOSIS of COVID-19

Prior respondents lacked a medical diagnosis in 28.89%. Yet they responded to the questionnaire as persons affected with "long-term" COVID-19. This is of course a critical component of how patients with this illness present to the extant medical system. This has been covered here in the Answers section, Question 20. Diagnostic tests were negative in 38.93%, which was a majority of respondents. Question 26 details other responses given. Only 21.37% reported a positive nasal swab. When asked phrased in reverse, 56.91% had a negative nasal swab, 37.4% a negative oral swab, and 27.64% a negative antibody test.

 

While a positive or confirmatory test for an illness is always comforting from a diagnostic perspective (not necessarily comforting for the patient), should only those with a positive antigen or antibody test be included in this study?

 

We think not, preferring to rely on the pattern of physical and emotional symptoms as presented below to decide on study admission of a potential participant.

 

PRE-ILLNESS HEALTH STATUS

Self-assessment of health was presented in Question 31's answers

The majority response was "Status typical for age; Ok I guess' (42.22%). The second most common response was 'Perfect health' (23.70%). "1 important health problem" was present in 21.48% of respondents.

 

Symptoms commonly experienced before this viral illness have been presented in the Answers to Quesion 37 of the prior questionnaire. The most common frequent prior symptom was 'Headache'. The list is long, but allows consideration of chronicity of some symptoms also attributed to the "long-term" COVID-19 illness.

Barring severe ongoing medical illness, complaints as identified in Question 37 need not exclude a person seeking to participate in the study. Cardiovascular system involvement was present in 17.56% before COVID-19. In interviewing a potential enrollee, such symptoms that suggest possible increases in risk of further injury or illness from present study participation, will be carefully sought out.

 

Prior symptoms before acquiring COVID-19 or their absence, are not used to exclude nor include a potential participant.

 

SYMPTOMS

This study includes evaluation of the effectiveness of an intervention in the setting of "long-term" COVID-19.

This evaluation takes the form of a questionnaire repeated at 4 times, and focusing on levels of severity of specific physical and emotional symptoms and any possible evolution in these during the present study. This represents a subjective assessment. Objective data are also gathered separately as noted elsewhere.

 

This list is based on the obtained frequencies of those symptoms discovered by the questionnaire last Fall. The top 20 symptoms, sorted by frequency are further pursued in the present study.

 

It would add little to the study if an enrollee had none of these symptoms, even if considering herself or himself a victim of "long-term" COVID-19.

 

  So an inclusion/ exclusion criterion has been established as follows:  

 

In reviewing this list of 20 most frequent symptoms, a potential enrollee in the study must have experienced at least 10 of these at some point, and still be experiencing at least 5 currently.

 

On the page linked to above, the list is also offered as a checklist in PDF format, but also found here.

 

Other reasons for inclusion or exclusion are related to the demands of participation.

What is expected of a participating enrollee?

One may fit the mold of someone who should or could be in the present study.

And yet, what is asked for and expected, may not suit a given individual.

The study requires daily motivation and activities for 31 consecutive days.

Not your style? ...

This becomes a self-imposed reason for exclusion. And no hard feelings!

 

If you know a person who you think is right for this study, don't hesitate to copy and share the

link to this site and this page. (Right click on the link and select 'Copy link address' and paste in a message or email).

 

These tasks are defined by the study's protocol which can be found here.

 

These enrollee tasks and what they require will be presented next.

 

 

Enrollee Tasks >>>>

 

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27/04/2021
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