Covid19CAPSNCT05037110
Physical Activity and Smell Trainings to Help Individuals With Coronavirus Disease (COVID-19) Recover From Persistent Smell and Taste Impairments - A Pilot Study
A study testing Physical activity and Smell training in people with Covid19, run by Université de Montréal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Physical activity and Smell training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 25 Oct 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Université de Montréal
Montreal, Quebec, H3C 3J7
Marie-Eve Mathieu, 5143436737, me.mathieu@umontreal.ca
About this study
Official title: Physical Activity and Sensory Trainings to Help COVID-19 Patients Recover From Persistent Smell and Taste Impairments - A Pilot Study
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.
- Conditions
- Covid19
- Being tested
- Physical activity, Smell training
- Keywords
- Olfactory training, Physical activity, Chemosensory impairments, Persistent smell impairment
- Medical subject headings
- COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
For 12 weeks, do 150 minutes of moderate physical activity per week and wear a smart watch to monitor this physical activity goal. This is done remotely. Then, every two weeks, attend a remote individual meeting with a kinesiologist using a secured application (15 minutes each). Each online meeting will contain the following steps: 1) Review of health and activities recorded by the activity watch/app provided to the participant; 2) Discussion on how to reach/maintain the physical activity goal in the coming weeks according to individual health status, facilitators and barriers; 3) Elaboration of the next 2-week action plan.
Smell trainingOther
For 12 weeks, morning and evening, smell four odors namely eucalyptol, phenyl ethanol, citronellal, and eugenol, for a total of five minutes per session. For each smell training session, complete a short, online survey regarding the pleasantness and intensity of the smell. This is done remotely. Then, every two weeks, attend a remote individual meeting with a research professional using secured application (15 minutes each). Each online meeting will contain the following steps: 1) Review of smell training; 2) Discussion on how to reach/maintain the training protocol in the coming weeks according to individual health status, facilitators and barriers; 3) Elaboration of the next 2-week action plan.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity group | Experimental | Not described Receives: Behavioral: Physical activity |
| Chemosensory training group | Experimental | Not described Receives: Other: Smell training |
| Control group | No intervention | For 12 weeks, continue the participant's routine (no intervention). This is done remotely. Then, every two weeks, complete an online follow-up questionnaire (15 minutes each). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in olfactory score on the 40-item University of Pennsylvania Smell Identification Test (UPSIT) at week 14
The UPSIT test is a validated self-administered test that assesses olfactory function. In this test, odorants are released when participants scratch the standardized odor-impregnated test booklet. After smelling the odor, participants identify the smell from a list of odorants. Possible scores range from 0 to 40, where a higher score means a higher olfactory function.
Change = (Week 14 Score - Baseline Score)
Measured: Baseline and Week 14
Changes from Week 14 in olfactory score on the 40-item University of Pennsylvania Smell Identification Test (UPSIT) at Week 26.
The UPSIT test is a validated self-administered test that assesses olfactory function. In this test, odorants are released when participants scratch the standardized odor-impregnated test booklet. After smelling the odor, participants identify the smell from a list of odorants. Possible scores range from 0 to 40, where a higher score means a higher olfactory function.
Change = (Week 26 Score - Week 14 Score)
Measured: Week 14 and Week 26
Changes from Baseline in Gustatory Score on the 27-item Waterless Empirical Taste Test (WETT-SA) at Week 14
The WETT-SA test is a validated self-administered test that assesses gustatory function. Participants rub each strip, one at a time, on their tongues in a circular fashion. Then, they have to indicate what they tasted from a provided list of answers. Participants' answers are compared to an answer key and a higher score means a higher gustatory function
Change = (Week 14 Score - Baseline Score)
Measured: Baseline and Week 14
Changes from Week 14 in Gustatory Score on the 27-item Waterless Empirical Taste Test (WETT-SA) at Week 26
The WETT-SA test is a validated self-administered test that assesses gustatory function. Participants rub each strip, one at a time, on their tongues in a circular fashion. Then, they have to indicate what they tasted from a provided list of answers. Participants' answers are compared to an answer key and a higher score means a higher gustatory function
Change = (Week 26 Score - Week 14 Score)
Measured: Week 14 and Week 26
Changes from Baseline in Quality of Life on the 26-item World Health Organizations Quality of Life - Bref (WHOQoL-Bref) Questionnaire at Week 14
This is a validated questionnaire that assesses the quality of life. Each item is rated on a 5-point Likert scale. The higher the score, the higher the quality of life of the individual.
Change = (Week 14 Results - Baseline Results)
Measured: Baseline and Week 14
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
This is a validated questionnaire that assesses the quality of life. Each item is rated on a 5-point Likert scale. The higher the score, the higher the quality of life of the individual.
Change = (Week 26 Results - Week 14 Results)
Measured: Week 14 and Week 26
Changes from Baseline in Food Preference on the Leeds Food Preference Questionnaire (LFPQ) at Week 14
LFPQ is a validated software that assesses food preferences. Participants are presented with food items. Participants have to indicate "How pleasant would it be to experience a mouthful of this food now?". Then, they are presented with two food items, and they have to decide which of those items they would prefer to eat now.
This questionnaire is filled by participants in the in-person subgroup only.
Change = (Week 14 Results - Baseline Results)
Measured: Baseline and Week 14
Changes from Week 14 in Food Preference on the Leeds Food Preference Questionnaire (LFPQ) at Week 26
LFPQ is a validated software that assesses food preferences. Participants are presented with food items. Participants have to indicate "How pleasant would it be to experience a mouthful of this food now?". Then, they are presented with two food items, and they have to decide which of those items they would prefer to eat now.
This questionnaire is filled by participants in the in-person subgroup only.
Change = (Week 26 Results - Week 14 Results)
Measured: Week 14 and Week 26
Changes from Baseline in Brain Responses Following Smell Stimulations at Week 14
Brain responses to smell stimulations an olfactometer will be recorded by an electroencephalogram.
- The olfactometer is a device that gently blows different odors into the participant's nose at specific time intervals.
- The electroencephalogram is a non-invasive device that records the electrical activity of the participant's brain. Electrical sensors are placed on helmet-like equipment that the participant wears while he/she smells or tastes samples.
The brain activity is measured; smell event-related potentials (latency, duration, and amplitude) using an electroencephalogram are obtained.
This procedure is done by participants in the in-person subgroup only.
Change = (Baseline Results - Week 14 Results)
Measured: Baseline and Week 14
Changes from Baseline in Brain Responses Following Taste Stimulations at Week 14
Brain responses to taste stimulations using a gustometer will be recorded by an electroencephalogram.
- The gustometer is a device that puts drops of different flavors on the participant's tongue at specific time intervals.
- The electroencephalogram is a non-invasive device that records the electrical activity of the participant's brain. Electrical sensors are placed on helmet-like equipment that the participant wears while he/she smells or tastes samples.
The brain activity is measured; taste event-related potentials (latency, duration, and amplitude) using an electroencephalogram are obtained.
This procedure is done by participants in the in-person subgroup only.
Change = (Baseline Results - Week 14 Results)
Measured: Baseline and Week 14
Changes from Week 14 in Brain Responses Following Smell Stimulations at Week 26
Brain responses to smell stimulations using an olfactometer will be recorded by an electroencephalogram.
- The olfactometer is a device that gently blows different odors into the participant's nose at specific time intervals.
- The electroencephalogram is a non-invasive device that records the electrical activity of the participant's brain. Electrical sensors are placed on helmet-like equipment that the participant wears while he/she smells or tastes samples.
The brain activity is measured; smell event-related potentials (latency, duration, and amplitude) using an electroencephalogram are obtained.
This procedure is done by participants in the in-person subgroup only.
Change = (Week 26 Results - Week 14 Results)
Measured: Week 14 and Week 26
Changes from Week 14 in Brain Responses Following Taste Stimulations at Week 26
Brain responses to taste stimulations using a gustometer will be recorded by an electroencephalogram.
- The gustometer is a device that puts drops of different flavors on the participant's tongue at specific time intervals.
- The electroencephalogram is a non-invasive device that records the electrical activity of the participant's brain. Electrical sensors are placed on helmet-like equipment that the participant wears while he/she smells or tastes samples.
The brain activity is measured; taste event-related potentials (latency, duration, and amplitude) using an electroencephalogram are obtained.
This procedure is done by participants in the in-person subgroup only.
Change = (Week 26 Results - Week 14 Results)
Measured: Week 14 and Week 26
Changes from Baseline in food intake on the four 24-hour dietary recall at Week 14
Validated web-based 24-hour dietary recalls assess the food intake of the participant over the past 24 hours. Participant reports what they have eaten over 24-hours, meal by meal. They are presented with different portion sizes from which they have to select the one corresponding to each food item. This will be completed on four different days within the week following the laboratory visit. Then, calories and macronutrients are calculated.
These questionnaires are filled by participants in the in-person subgroup only.
Change = (Week 14 Results - Baseline Results)
Measured: Baseline and Week 14
Changes from Week 14 in food intake on the four 24-hour dietary recall at Week 26
Validated web-based 24-hour dietary recalls assess the food intake of the participant over the past 24 hours. Participant reports what they have eaten over 24-hours, meal by meal. They are presented with different portion sizes from which they have to select the one corresponding to each food item. This will be completed on four different days within the week following the laboratory visit. Then, calories and macronutrients are calculated.
These questionnaires are filled by participants in the in-person subgroup only.
Change = (Week 26 Results - Week 14 Results)
Measured: Week 14 and Week 26
Secondary outcomes (2)
Change from Baseline in physical activity level on the International Physical Activity Questionnaire (IPAQ) at week 14
IPAQ is a validated questionnaire. It assesses the physical activity level of participants over the past seven days. Based on the provided answer, a multiple of the estimated resting energy expenditure (METs) is calculated. Higher the METs value, the higher the physical activity level of the person.
Change = (Week 14 Results - Baseline Results)
Measured: Baseline and Week 14
Change from Week 14 in physical activity level on the International Physical Activity Questionnaire (IPAQ) at week 26
IPAQ is a validated questionnaire. It assesses the physical activity level of participants over the past seven days. Based on the provided answer, a multiple of the estimated resting energy expenditure (METs) is calculated. Higher the METs value, the higher the physical activity level of the person.
Change = (Week 26 Results - Week 14 Results)
Measured: Week 14 and Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start25 Oct 2021
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Ève Mathieu, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037110
- Sponsor's protocol ID
- 2021-374
- Acronym
- CAPS
- Status last verified
- Nov 2021
- First submitted
- 2 Sep 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The analyses will be centralized in Dr. Mathieu's laboratory and collaborations are welcomed.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Sensory Trainings to Help COVID-19 Patients Recover From Persistent Smell and Taste Impairments - A Pilot Study
- ClinicalTrials.gov ID
- NCT05037110
- Acronym / sponsor ID
- CAPS / 2021-374
- Conditions
- Covid19
- Keywords
- Olfactory training, Physical activity, Chemosensory impairments, Persistent smell impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical activity group | Experimental | Behavioral: Physical activity |
| Chemosensory training group | Experimental | Other: Smell training |
| Control group | No intervention | –For 12 weeks, continue the participant's routine (no intervention). This is done remotely. Then, every two weeks, complete an online follow-up questionnaire (15 minutes each). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityFor 12 weeks, do 150 minutes of moderate physical activity per week and wear a smart watch to monitor this physical activity goal. This is done remotely. Then, every two weeks, attend a remote individual meeting with a kinesiologist using a secured application (15 minutes each). Each online meeting will contain the following steps: 1) Review of health and activities recorded by the activity watch/app provided to the participant; 2) Discussion on how to reach/maintain the physical activity goal in the coming weeks according to individual health status, facilitators and barriers; 3) Elaboration of the next 2-week action plan. | Behavioural | Physical activity group |
| Smell trainingFor 12 weeks, morning and evening, smell four odors namely eucalyptol, phenyl ethanol, citronellal, and eugenol, for a total of five minutes per session. For each smell training session, complete a short, online survey regarding the pleasantness and intensity of the smell. This is done remotely. Then, every two weeks, attend a remote individual meeting with a research professional using secured application (15 minutes each). Each online meeting will contain the following steps: 1) Review of smell training; 2) Discussion on how to reach/maintain the training protocol in the coming weeks according to individual health status, facilitators and barriers; 3) Elaboration of the next 2-week action plan. | Other | Chemosensory training group |
Primary outcome
Changes from baseline in olfactory score on the 40-item University of Pennsylvania Smell Identification Test (UPSIT) at week 14
Time frame: Baseline and Week 14
The UPSIT test is a validated self-administered test that assesses olfactory function. In this test, odorants are released when participants scratch the standardized odor-impregnated test booklet. After smelling the odor, participants identify the smell from a list of odorants. Possible scores range from 0 to 40, where a higher score means a higher olfactory function. Change = (Week 14 Score - Baseline Score)
Changes from Week 14 in olfactory score on the 40-item University of Pennsylvania Smell Identification Test (UPSIT) at Week 26.
Time frame: Week 14 and Week 26
The UPSIT test is a validated self-administered test that assesses olfactory function. In this test, odorants are released when participants scratch the standardized odor-impregnated test booklet. After smelling the odor, participants identify the smell from a list of odorants. Possible scores range from 0 to 40, where a higher score means a higher olfactory function. Change = (Week 26 Score - Week 14 Score)
Changes from Baseline in Gustatory Score on the 27-item Waterless Empirical Taste Test (WETT-SA) at Week 14
Time frame: Baseline and Week 14
The WETT-SA test is a validated self-administered test that assesses gustatory function. Participants rub each strip, one at a time, on their tongues in a circular fashion. Then, they have to indicate what they tasted from a provided list of answers. Participants' answers are compared to an answer key and a higher score means a higher gustatory function Change = (Week 14 Score - Baseline Score)
Changes from Week 14 in Gustatory Score on the 27-item Waterless Empirical Taste Test (WETT-SA) at Week 26
Time frame: Week 14 and Week 26
The WETT-SA test is a validated self-administered test that assesses gustatory function. Participants rub each strip, one at a time, on their tongues in a circular fashion. Then, they have to indicate what they tasted from a provided list of answers. Participants' answers are compared to an answer key and a higher score means a higher gustatory function Change = (Week 26 Score - Week 14 Score)
Changes from Baseline in Quality of Life on the 26-item World Health Organizations Quality of Life - Bref (WHOQoL-Bref) Questionnaire at Week 14
Time frame: Baseline and Week 14
This is a validated questionnaire that assesses the quality of life. Each item is rated on a 5-point Likert scale. The higher the score, the higher the quality of life of the individual. Change = (Week 14 Results - Baseline Results)
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
Time frame: Week 14 and Week 26
This is a validated questionnaire that assesses the quality of life. Each item is rated on a 5-point Likert scale. The higher the score, the higher the quality of life of the individual. Change = (Week 26 Results - Week 14 Results)
Changes from Baseline in Food Preference on the Leeds Food Preference Questionnaire (LFPQ) at Week 14
Time frame: Baseline and Week 14
LFPQ is a validated software that assesses food preferences. Participants are presented with food items. Participants have to indicate "How pleasant would it be to experience a mouthful of this food now?". Then, they are presented with two food items, and they have to decide which of those items they would prefer to eat now. This questionnaire is filled by participants in the in-person subgroup only. Change = (Week 14 Results - Baseline Results)
Changes from Week 14 in Food Preference on the Leeds Food Preference Questionnaire (LFPQ) at Week 26
Time frame: Week 14 and Week 26
LFPQ is a validated software that assesses food preferences. Participants are presented with food items. Participants have to indicate "How pleasant would it be to experience a mouthful of this food now?". Then, they are presented with two food items, and they have to decide which of those items they would prefer to eat now. This questionnaire is filled by participants in the in-person subgroup only. Change = (Week 26 Results - Week 14 Results)
Changes from Baseline in Brain Responses Following Smell Stimulations at Week 14
Time frame: Baseline and Week 14
Brain responses to smell stimulations an olfactometer will be recorded by an electroencephalogram. * The olfactometer is a device that gently blows different odors into the participant's nose at specific time intervals. * The electroencephalogram is a non-invasive device that records the electrical activity of the participant's brain. Electrical sensors are placed on helmet-like equipment that the participant wears while he/she smells or tastes samples. The brain activity is measured; smell event-related potentials (latency, duration, and amplitude) using an electroencephalogram are obtained. This procedure is done by participants in the in-person subgroup only. Change = (Baseline Results - Week 14 Results)
Changes from Baseline in Brain Responses Following Taste Stimulations at Week 14
Time frame: Baseline and Week 14
Brain responses to taste stimulations using a gustometer will be recorded by an electroencephalogram. * The gustometer is a device that puts drops of different flavors on the participant's tongue at specific time intervals. * The electroencephalogram is a non-invasive device that records the electrical activity of the participant's brain. Electrical sensors are placed on helmet-like equipment that the participant wears while he/she smells or tastes samples. The brain activity is measured; taste event-related potentials (latency, duration, and amplitude) using an electroencephalogram are obtained. This procedure is done by participants in the in-person subgroup only. Change = (Baseline Results - Week 14 Results)
Changes from Week 14 in Brain Responses Following Smell Stimulations at Week 26
Time frame: Week 14 and Week 26
Brain responses to smell stimulations using an olfactometer will be recorded by an electroencephalogram. * The olfactometer is a device that gently blows different odors into the participant's nose at specific time intervals. * The electroencephalogram is a non-invasive device that records the electrical activity of the participant's brain. Electrical sensors are placed on helmet-like equipment that the participant wears while he/she smells or tastes samples. The brain activity is measured; smell event-related potentials (latency, duration, and amplitude) using an electroencephalogram are obtained. This procedure is done by participants in the in-person subgroup only. Change = (Week 26 Results - Week 14 Results)
Changes from Week 14 in Brain Responses Following Taste Stimulations at Week 26
Time frame: Week 14 and Week 26
Brain responses to taste stimulations using a gustometer will be recorded by an electroencephalogram. * The gustometer is a device that puts drops of different flavors on the participant's tongue at specific time intervals. * The electroencephalogram is a non-invasive device that records the electrical activity of the participant's brain. Electrical sensors are placed on helmet-like equipment that the participant wears while he/she smells or tastes samples. The brain activity is measured; taste event-related potentials (latency, duration, and amplitude) using an electroencephalogram are obtained. This procedure is done by participants in the in-person subgroup only. Change = (Week 26 Results - Week 14 Results)
Changes from Baseline in food intake on the four 24-hour dietary recall at Week 14
Time frame: Baseline and Week 14
Validated web-based 24-hour dietary recalls assess the food intake of the participant over the past 24 hours. Participant reports what they have eaten over 24-hours, meal by meal. They are presented with different portion sizes from which they have to select the one corresponding to each food item. This will be completed on four different days within the week following the laboratory visit. Then, calories and macronutrients are calculated. These questionnaires are filled by participants in the in-person subgroup only. Change = (Week 14 Results - Baseline Results)
Changes from Week 14 in food intake on the four 24-hour dietary recall at Week 26
Time frame: Week 14 and Week 26
Validated web-based 24-hour dietary recalls assess the food intake of the participant over the past 24 hours. Participant reports what they have eaten over 24-hours, meal by meal. They are presented with different portion sizes from which they have to select the one corresponding to each food item. This will be completed on four different days within the week following the laboratory visit. Then, calories and macronutrients are calculated. These questionnaires are filled by participants in the in-person subgroup only. Change = (Week 26 Results - Week 14 Results)
2 secondary outcomes
Change from Baseline in physical activity level on the International Physical Activity Questionnaire (IPAQ) at week 14
Time frame: Baseline and Week 14
Change from Week 14 in physical activity level on the International Physical Activity Questionnaire (IPAQ) at week 26
Time frame: Week 14 and Week 26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Individual participant dataSharing planned: No. The analyses will be centralized in Dr. Mathieu's laboratory and collaborations are welcomed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity and Smell training in people with Covid19, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Eve Mathieu, PhD (514 343-6737, me.mathieu@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in olfactory score on the 40-item University of Pennsylvania Smell Identification Test (UPSIT) at week 14 (time frame: Baseline and Week 14). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.