Recruiting

Physical Activity & Smell Trainings

Sponsor:

Université de Montréal

Code:

NCT05037110

Conditions

Covid19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Physical activity

Smell training

Study Details

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.

Conditions

Covid19

Study ID

NCT05037110

Start date

Oct 25, 2021

Status verified date

Nov, 2021

Completion date

Jun, 2023

Anticipated

Primary completion date

Jun, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Physical activity group

experimental: Chemosensory training group

no intervention: Control group

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).

Interventions

Physical activity

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 training

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

  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Changes from Baseline in Food Preference on the Leeds Food Preference Questionnaire (LFPQ) at Week 14 [ Time Frame: Baseline and Week 14 ]
  • Changes from Week 14 in Food Preference on the Leeds Food Preference Questionnaire (LFPQ) at Week 26 [ Time Frame: Week 14 and Week 26 ]
  • Changes from Baseline in Brain Responses Following Smell Stimulations at Week 14 [ Time Frame: Baseline and Week 14 ]
  • Changes from Baseline in Brain Responses Following Taste Stimulations at Week 14 [ Time Frame: Baseline and Week 14 ]
  • Changes from Week 14 in Brain Responses Following Smell Stimulations at Week 26 [ Time Frame: Week 14 and Week 26 ]
  • Changes from Week 14 in Brain Responses Following Taste Stimulations at Week 26 [ Time Frame: Week 14 and Week 26 ]
  • Changes from Baseline in food intake on the four 24-hour dietary recall at Week 14 [ Time Frame: Baseline and Week 14 ]
  • Changes from Week 14 in food intake on the four 24-hour dietary recall at Week 26 [ Time Frame: Week 14 and Week 26 ]

Central Contacts and Locations

Central contacts

Marie-Eve Mathieu, PhD

514 343-6737me.mathieu@umontreal.ca

Locations

Université de Montréal

Recruiting

Montréal, Quebec, Canada, H3C 3J7

Contacts

Marie-Eve Mathieu

5143436737me.mathieu@umontreal.ca

More Information

Sponsor

Université de Montréal

Last update posted

Nov 17, 2021

Last verified

Nov, 2021

Keywords

  • Olfactory training
  • Physical activity
  • Chemosensory impairments
  • Persistent smell impairment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Montréal on 2021-11-17.