Ignite Creation Date:
2024-05-06 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05037110
Status:
UNKNOWN
Last Update Posted:
2021-11-17
First Post:
2021-09-02
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
Sponsor:
Université de Montréal
Organization:
Université de Montréal
Study Overview
Official Title:
Physical Activity and Sensory Trainings to Help COVID-19 Patients Recover From Persistent Smell and Taste Impairments - A Pilot Study
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPS
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None