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Physical Activity and Smell Trainings to Help Individuals With Coronavirus Disease (COVID-19) Recover From Persistent Smell and Taste Impairments - A Pilot Study (CAPS)

Primary Purpose

Covid19

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physical activity
Smell training
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Olfactory training, Physical activity, Chemosensory impairments, Persistent smell impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Université de MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Physical activity group

Chemosensory training group

Control group

Arm Description

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).

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Secondary Outcome Measures

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)
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)

Full Information

First Posted
September 2, 2021
Last Updated
November 9, 2021
Sponsor
Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT05037110
Brief Title
Physical Activity and Smell Trainings to Help Individuals With Coronavirus Disease (COVID-19) Recover From Persistent Smell and Taste Impairments - A Pilot Study
Acronym
CAPS
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Olfactory training, Physical activity, Chemosensory impairments, Persistent smell impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical activity group
Arm Type
Experimental
Arm Title
Chemosensory training group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Smell training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from baseline in olfactory score on the 40-item University of Pennsylvania Smell Identification Test (UPSIT) at week 14
Description
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)
Time Frame
Baseline and Week 14
Title
Changes from Week 14 in olfactory score on the 40-item University of Pennsylvania Smell Identification Test (UPSIT) at Week 26.
Description
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)
Time Frame
Week 14 and Week 26
Title
Changes from Baseline in Gustatory Score on the 27-item Waterless Empirical Taste Test (WETT-SA) at Week 14
Description
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)
Time Frame
Baseline and Week 14
Title
Changes from Week 14 in Gustatory Score on the 27-item Waterless Empirical Taste Test (WETT-SA) at Week 26
Description
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)
Time Frame
Week 14 and Week 26
Title
Changes from Baseline in Quality of Life on the 26-item World Health Organizations Quality of Life - Bref (WHOQoL-Bref) Questionnaire at Week 14
Description
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)
Time Frame
Baseline and Week 14
Title
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
Description
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)
Time Frame
Week 14 and Week 26
Title
Changes from Baseline in Food Preference on the Leeds Food Preference Questionnaire (LFPQ) at Week 14
Description
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)
Time Frame
Baseline and Week 14
Title
Changes from Week 14 in Food Preference on the Leeds Food Preference Questionnaire (LFPQ) at Week 26
Description
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)
Time Frame
Week 14 and Week 26
Title
Changes from Baseline in Brain Responses Following Smell Stimulations at Week 14
Description
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)
Time Frame
Baseline and Week 14
Title
Changes from Baseline in Brain Responses Following Taste Stimulations at Week 14
Description
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)
Time Frame
Baseline and Week 14
Title
Changes from Week 14 in Brain Responses Following Smell Stimulations at Week 26
Description
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)
Time Frame
Week 14 and Week 26
Title
Changes from Week 14 in Brain Responses Following Taste Stimulations at Week 26
Description
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)
Time Frame
Week 14 and Week 26
Title
Changes from Baseline in food intake on the four 24-hour dietary recall at Week 14
Description
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)
Time Frame
Baseline and Week 14
Title
Changes from Week 14 in food intake on the four 24-hour dietary recall at Week 26
Description
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)
Time Frame
Week 14 and Week 26
Secondary Outcome Measure Information:
Title
Change from Baseline in physical activity level on the International Physical Activity Questionnaire (IPAQ) at week 14
Description
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)
Time Frame
Baseline and Week 14
Title
Change from Week 14 in physical activity level on the International Physical Activity Questionnaire (IPAQ) at week 26
Description
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)
Time Frame
Week 14 and Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Eve Mathieu, PhD
Phone
514 343-6737
Email
me.mathieu@umontreal.ca
Facility Information:
Facility Name
Université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3C 3J7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Eve Mathieu
Phone
5143436737
Email
me.mathieu@umontreal.ca

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The analyses will be centralized in Dr. Mathieu's laboratory and collaborations are welcomed.

Learn more about this trial

Physical Activity and Smell Trainings to Help Individuals With Coronavirus Disease (COVID-19) Recover From Persistent Smell and Taste Impairments - A Pilot Study

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