Clinical trial NCT05037110: Physical Activity and Smell Trainings to Help Individuals With Coronavirus Disease (COVID-19) Recover From Persistent Smell and Taste Impairments - A Pilot Study
Official title: Physical Activity and Sensory Trainings to Help COVID-19 Patients Recover From Persistent Smell and Taste Impairments - A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Keywords: Olfactory training
Physical activity
Chemosensory impairments
Persistent smell impairment
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to identify efficient treatments to help those with chemosensory losses due to Coronavirus disease (COVID-19). To do so, 75 participants, men and women, aged 18 years old and above living in Canada will be recruited. Participants will be randomly assigned to one of the following three groups (25 in each group): physical activity, smell training, and control. Here is a quick summary of what participants in each group will have to do remotely during 12 weeks:

* Physical activity group: Engage in physical activity for 12 weeks and wear a smart watch daily. Attend a 15-minute virtual meeting with a research professional every two weeks, that is six times during the 12 weeks.
* Smell training group: Smell four odors twice a day for 12 weeks and evaluate their sensory perceptions via an online survey sent for each session specifically. Attend a 15-minute virtual meeting with a research professional every two weeks, that is six times during the 12 weeks.
* Control group: Not change their usual routine for 12 weeks. Complete an online 15-minute follow-up questionnaire every two weeks, that is six times over the 12 weeks.

In addition, within each group, 10 individuals from Montreal, Quebec will be randomly selected to complete additional assessments in the laboratory. To distinguish this subgroup, it is called the "in-person subgroup." Participants will be assessed at the beginning of the intervention period, immediately after the intervention period, and 12 weeks after the end of the intervention period. The assessments include various questionnaires on sociodemographic data, physical and mental health, lifestyle habits, sensory dysfunction, nutritional preferences, as well as self-administered smell and taste tests sent by mail. The in-person subgroup only will have to do the following additional assessments: smell and taste tests using special equipment (olfactometer, gustometer, electroencephalogram) and online questionnaires on food intake for the day.


Eligibility criteria: Inclusion Criteria:

* Be 18 years old and above
* Have had COVID-19 diagnosed by laboratory tests
* Have recovered from COVID-19
* Have persistent problems with your sense of smell and/or taste due to COVID-19 in the past 3 months or more (priority to participants with only this complication)
* Have access to a computer and internet connection and be able to download the Zoom application
* Have access to a smart phone ("texting" and Bluetooth)
* Live in Canada

Exclusion Criteria:

* Do 150 minutes or more of physical activity that makes you out of breath every week
* Have limitations related to a training aiming at improving the sense of smell
* Have physical limitations that may limit physical activity
* Be part of another study that may influence the current study

Primary outcomes:
measure: Changes from baseline in olfactory score on the 40-item University of Pennsylvania Smell Identification Test (UPSIT) at week 14
timeFrame: Baseline and Week 14
measure: Changes from Week 14 in olfactory score on the 40-item University of Pennsylvania Smell Identification Test (UPSIT) at Week 26.
timeFrame: Week 14 and Week 26
measure: Changes from Baseline in Gustatory Score on the 27-item Waterless Empirical Taste Test (WETT-SA) at Week 14
timeFrame: Baseline and Week 14
measure: Changes from Week 14 in Gustatory Score on the 27-item Waterless Empirical Taste Test (WETT-SA) at Week 26
timeFrame: Week 14 and Week 26
measure: Changes from Baseline in Quality of Life on the 26-item World Health Organizations Quality of Life - Bref (WHOQoL-Bref) Questionnaire at Week 14
timeFrame: Baseline and Week 14
measure: Changes from Week 14 in Quality of Life on the 26-item World Health Organizations Quality of Life - Bref (WHOQoL-Bref) Questionnaire at Week 26
timeFrame: Week 14 and Week 26
measure: Changes from Baseline in Food Preference on the Leeds Food Preference Questionnaire (LFPQ) at Week 14
timeFrame: Baseline and Week 14
measure: Changes from Week 14 in Food Preference on the Leeds Food Preference Questionnaire (LFPQ) at Week 26
timeFrame: Week 14 and Week 26
measure: Changes from Baseline in Brain Responses Following Smell Stimulations at Week 14
timeFrame: Baseline and Week 14
measure: Changes from Baseline in Brain Responses Following Taste Stimulations at Week 14
timeFrame: Baseline and Week 14
measure: Changes from Week 14 in Brain Responses Following Smell Stimulations at Week 26
timeFrame: Week 14 and Week 26
measure: Changes from Week 14 in Brain Responses Following Taste Stimulations at Week 26
timeFrame: Week 14 and Week 26
measure: Changes from Baseline in food intake on the four 24-hour dietary recall at Week 14
timeFrame: Baseline and Week 14
measure: Changes from Week 14 in food intake on the four 24-hour dietary recall at Week 26
timeFrame: Week 14 and Week 26
Secondary outcomes:
measure: Change from Baseline in physical activity level on the International Physical Activity Questionnaire (IPAQ) at week 14
timeFrame: Baseline and Week 14
measure: Change from Week 14 in physical activity level on the International Physical Activity Questionnaire (IPAQ) at week 26
timeFrame: Week 14 and Week 26
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Université de Montréal
state: Quebec
Study officials:
References: