Healthy AgingPACManNCT06100224
Piloting a Healthy Aging Cohort in Manitoba
An observational study of Healthy Aging, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this study is to set up and pilot baseline and year 1 data collection for a prospective cohort designed to explore the relationships between medical fitness facility usage, lifestyle behaviours and health outcomes as individuals age. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2024to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from individuals that attend The Wellness Institute. This study is a pilot with the number of recruited participants set as the initial 20 plus an additional anticipated 80, totaling 100 participants.
Who may be able to join
- Individuals, aged 30 years or older at the time of signing the informed consent
- Able to communicate in English and provide written informed consent
- Current member of the Wellness Institute
- Access to a device such as an android or iOS smartphone or tablet for use with the dietary tracking application.
Who cannot join
- Female participant who is pregnant or lactating
- Employees of the Wellness Institute
- Involvement in the planning and/or conduct of the study
Trial locations and contacts
1 site in 1 country.
Canada1 site
Seven Oaks Hospital Chronic Disease Innovation Centre
Winnipeg, Manitoba, R2V 3M3
About this study
Official title: Piloting a Healthy Aging Cohort in Manitoba - PACMan
The purpose of this study is to set up and pilot baseline and year 1 data collection for a prospective cohort designed to explore the relationships between medical fitness facility usage, lifestyle behaviours and health outcomes as individuals age. Additionally, this pilot study will set up the overall objectives for the larger, prospective cohort study using a public engagement participatory approach with public/patient partners involved in determining which healthy aging outcomes to include.
Read the detailed description
This project will cover the set-up, development, and user-testing of the baseline visit data collection in the first 100 participants. Data will be collected on physical activity, diet, sleep, stress, cognition, frailty, health history (including diabetes, alcohol and smoking), facility and program usage at the Wellness Institute (WI), height, weight, volitional oxygen intake (VO2 max), blood pressure, heart rate, clinical chemistry, urinalysis, body composition, social determinants of health, and wellbeing.
Additionally, a public engagement participatory approach will be used to determine which healthy aging outcomes are important to study, including discussion on research priorities, research question, research design, data collection approaches, outcome measures, analysis of results, relevance of findings, and dissemination of findings. Therefore, this pilot project will include the formation of a project advisory group that will include public/patient partners. The advisory group members will discuss ideas around healthy aging and lifestyle and what outcomes are most important to them; and will provide information on the reasons for joining as well as the use of the medical fitness facility, any barriers they face and program needs. The project advisory group will be an integral part of this pilot project. The information obtained from the advisory group meetings and the pilot project will be used to develop the outcomes for the larger cohort study.
- Conditions
- Healthy Aging
- Keywords
- Medical fitness facility
What is being measured
The primary outcome is the main question the study is designed to answer.
Health History
Collected using the Chronic Conditions, Health History and Facility Usage Questionnaire and the Family Medical History Questionnaire
Measured: At baseline and Year 1
Fitness Level
Measured by volitional oxygen intake, otherwise known as VO2 max, using the Ebbeling Treadmill Test (a submaximal walking test)
Measured: At baseline and Year 1
Diet
Measured using the Mindful Eating Questionnaire and the 3 Factor Eating Questionnaire
Measured: At Baseline and Year 1
Dietary Intake
The RxFood App will be used to measure dietary intake over 3 full days.
Measured: At Baseline and Year 1
Physical Activity
Measured using the International Physical Activity Questionnaire - Short form (IPAQ-S)
Measured: At Baseline and Year 1
Physical Activity Assessment
An Actigraph activity monitor will be used to measure physical activity for 7 days, wtih participants asked to wear the monitor at all times.
Measured: At Baseline and Year 1
Sleep Quality Assessment
Measured using the Pittsburgh Sleep Quality Index Questionnaire (PSQI), an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction.
Measured: At Baseline and Year 1
Sleep Assessment
An ActiGraph activity monitor will be used to measure sleep quality patterns for 7 days, wtih participants asked to wear the monitor at all times, including when they sleep.
Measured: At Baseline and Year 1
Stress
The Perceived Stress Questionnaire (PSQ) will be completed to assess stressful life events and circumstances that tend to trigger or exacerbate disease symptoms.
Measured: At Baseline and Year 1
Cognition Assessment
The Montreal Cognitive Assessment Score (MoCA) will be used to give insight into how participants mentally process information.
Measured: At Baseline and Year 1
Body Weight
Body weight will be measured.
Measured: At Baseline and Year 1
Body Mass Index (BMI)
Body Mass Index will be measured
Measured: At Baseline and Year 1
Waist circumference
Waist circumference will be measured
Measured: At Baseline and Year 1
Blood Pressure
Blood pressure while awake, while asleep, and total will be measured using an ambulatory blood pressure monitor, worn for 3 consecutive days.
Measured: At Baseline and Year 1
Frailty
The Short Physical Performance Battery (balance test, gait speed, and chair stand) and handgrip strength with be collected to measure frailty.
Measured: At Baseline and Year 1
Facility Usage
Participants will complete a questionnaire on attendance in hours per week, and # of times per week, and specific program/facility usage at the Wellness Institute. The Wellness Institute swipe data will be used to record the number of times swiped per week and per month since joining.
Measured: At Baseline and Year 1
Cholesterol
Total cholesterol, HDL-C, LDL-C, triglycerides, total cholesterol/HDL ratio
Measured: At Baseline and Year 1
HbA1c
Hemoglobin A1C
Measured: At Baseline and Year 1
eGFR
Estimated glomerular filtration rate.
Measured: At Baseline and Year 1
uACR
Urine albumin to creatinine ratio
Measured: At Baseline and Year 1
10-Year Risk of Cardiovascular Disease
Measured using the Framingham Risk Score
Measured: At Baseline and Year 1
Cardiovascular Assessment
Identification of Metabolic Syndrome and the Framingham Risk Score will be measured.
Measured: At Baseline and Year 1
Body Composition
DEXA scan measurements including total mass, fat mass, lean mass, % fat, visceral adipose tissue, total body bone mineral density), and relative skeletal muscle index (RSMI) will be collected.
Measured: At Baseline and Year 1
Social Determinants of Health
Access to general medical and dental care, postal code, household income, education level and marital status will be collected.
Measured: At Baseline and Year 1
Wellbeing - Quality of Life
the EQ-5D-5L will be collected to measure quality of life.
Measured: At Baseline and Year 1
Wellbeing - Loneliness
The UCLA Loneliness Scale will be sued to measure loneliness.
Measured: At Baseline and Year 1
Wellbeing - Life Satisfaction
The Satisfaction With Life Scale will be used to measure life satisfaction
Measured: At Baseline and Year 1
Wellbeing - Self-efficacy
The Multidimensional Health Locus of Control (MHLC) Scale Form A will be used to measure self-efficacy
Measured: At Baseline and Year 1
Wellbeing - Depression
The Center for Epidemiologic Studies Short Depression Scale (CES-D-10) will be used to measure depression
Measured: At Baseline and Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Apr 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Seven Oaks Hospital Chronic Disease Innovation Centre, The Wellness Institute Powered by Seven Oaks General Hospital, Medical Fitness Association
- Responsible party
- Principal investigator, Claudio Rigatto, University of Manitoba
- Investigators
- Claudio Rigatto, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100224
- Sponsor's protocol ID
- 3566 / HS25790 (H2022:393)
- Acronym
- PACMan
- Status last verified
- Jun 2026
- First submitted
- 20 Oct 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Healthy Aging Cohort in Manitoba - PACMan
- ClinicalTrials.gov ID
- NCT06100224
- Acronym / sponsor ID
- PACMan / 3566 / HS25790 (H2022:393)
- Conditions
- Healthy Aging
- Keywords
- Medical fitness facility
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Seven Oaks Hospital Chronic Disease Innovation Centre, The Wellness Institute Powered by Seven Oaks General Hospital, Medical Fitness Association
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 25 Oct 2023 (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 purpose of this study is to set up and pilot baseline and year 1 data collection for a prospective cohort designed to explore the relationships between medical fitness facility usage, lifestyle behaviours and health outcomes as individuals age. Additionally, this pilot study will set up the overall objectives for the larger, prospective cohort study using a public engagement participatory approach with public/patient partners involved in determining which healthy aging outcomes to include.
Detailed description
This project will cover the set-up, development, and user-testing of the baseline visit data collection in the first 100 participants. Data will be collected on physical activity, diet, sleep, stress, cognition, frailty, health history (including diabetes, alcohol and smoking), facility and program usage at the Wellness Institute (WI), height, weight, volitional oxygen intake (VO2 max), blood pressure, heart rate, clinical chemistry, urinalysis, body composition, social determinants of health, and wellbeing.
Additionally, a public engagement participatory approach will be used to determine which healthy aging outcomes are important to study, including discussion on research priorities, research question, research design, data collection approaches, outcome measures, analysis of results, relevance of findings, and dissemination of findings. Therefore, this pilot project will include the formation of a project advisory group that will include public/patient partners. The advisory group members will discuss ideas around healthy aging and lifestyle and what outcomes are most important to them; and will provide information on the reasons for joining as well as the use of the medical fitness facility, any barriers they face and program needs. The project advisory group will be an integral part of this pilot project. The information obtained from the advisory group meetings and the pilot project will be used to develop the outcomes for the larger cohort study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from individuals that attend The Wellness Institute. This study is a pilot with the number of recruited participants set as the initial 20 plus an additional anticipated 80, totaling 100 participants.
Key inclusion criteria (4 listed)
- Individuals, aged 30 years or older at the time of signing the informed consent
- Able to communicate in English and provide written informed consent
- Current member of the Wellness Institute
- Access to a device such as an android or iOS smartphone or tablet for use with the dietary tracking application.
Key exclusion criteria (3 listed)
- Female participant who is pregnant or lactating
- Employees of the Wellness Institute
- Involvement in the planning and/or conduct of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health History
Time frame: At baseline and Year 1
Collected using the Chronic Conditions, Health History and Facility Usage Questionnaire and the Family Medical History Questionnaire
Fitness Level
Time frame: At baseline and Year 1
Measured by volitional oxygen intake, otherwise known as VO2 max, using the Ebbeling Treadmill Test (a submaximal walking test)
Diet
Time frame: At Baseline and Year 1
Measured using the Mindful Eating Questionnaire and the 3 Factor Eating Questionnaire
Dietary Intake
Time frame: At Baseline and Year 1
The RxFood App will be used to measure dietary intake over 3 full days.
Physical Activity
Time frame: At Baseline and Year 1
Measured using the International Physical Activity Questionnaire - Short form (IPAQ-S)
Physical Activity Assessment
Time frame: At Baseline and Year 1
An Actigraph activity monitor will be used to measure physical activity for 7 days, wtih participants asked to wear the monitor at all times.
Sleep Quality Assessment
Time frame: At Baseline and Year 1
Measured using the Pittsburgh Sleep Quality Index Questionnaire (PSQI), an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction.
Sleep Assessment
Time frame: At Baseline and Year 1
An ActiGraph activity monitor will be used to measure sleep quality patterns for 7 days, wtih participants asked to wear the monitor at all times, including when they sleep.
Stress
Time frame: At Baseline and Year 1
The Perceived Stress Questionnaire (PSQ) will be completed to assess stressful life events and circumstances that tend to trigger or exacerbate disease symptoms.
Cognition Assessment
Time frame: At Baseline and Year 1
The Montreal Cognitive Assessment Score (MoCA) will be used to give insight into how participants mentally process information.
Body Weight
Time frame: At Baseline and Year 1
Body weight will be measured.
Body Mass Index (BMI)
Time frame: At Baseline and Year 1
Body Mass Index will be measured
Waist circumference
Time frame: At Baseline and Year 1
Waist circumference will be measured
Blood Pressure
Time frame: At Baseline and Year 1
Blood pressure while awake, while asleep, and total will be measured using an ambulatory blood pressure monitor, worn for 3 consecutive days.
Frailty
Time frame: At Baseline and Year 1
The Short Physical Performance Battery (balance test, gait speed, and chair stand) and handgrip strength with be collected to measure frailty.
Facility Usage
Time frame: At Baseline and Year 1
Participants will complete a questionnaire on attendance in hours per week, and # of times per week, and specific program/facility usage at the Wellness Institute. The Wellness Institute swipe data will be used to record the number of times swiped per week and per month since joining.
Cholesterol
Time frame: At Baseline and Year 1
Total cholesterol, HDL-C, LDL-C, triglycerides, total cholesterol/HDL ratio
HbA1c
Time frame: At Baseline and Year 1
Hemoglobin A1C
eGFR
Time frame: At Baseline and Year 1
Estimated glomerular filtration rate.
uACR
Time frame: At Baseline and Year 1
Urine albumin to creatinine ratio
10-Year Risk of Cardiovascular Disease
Time frame: At Baseline and Year 1
Measured using the Framingham Risk Score
Cardiovascular Assessment
Time frame: At Baseline and Year 1
Identification of Metabolic Syndrome and the Framingham Risk Score will be measured.
Body Composition
Time frame: At Baseline and Year 1
DEXA scan measurements including total mass, fat mass, lean mass, % fat, visceral adipose tissue, total body bone mineral density), and relative skeletal muscle index (RSMI) will be collected.
Social Determinants of Health
Time frame: At Baseline and Year 1
Access to general medical and dental care, postal code, household income, education level and marital status will be collected.
Wellbeing - Quality of Life
Time frame: At Baseline and Year 1
the EQ-5D-5L will be collected to measure quality of life.
Wellbeing - Loneliness
Time frame: At Baseline and Year 1
The UCLA Loneliness Scale will be sued to measure loneliness.
Wellbeing - Life Satisfaction
Time frame: At Baseline and Year 1
The Satisfaction With Life Scale will be used to measure life satisfaction
Wellbeing - Self-efficacy
Time frame: At Baseline and Year 1
The Multidimensional Health Locus of Control (MHLC) Scale Form A will be used to measure self-efficacy
Wellbeing - Depression
Time frame: At Baseline and Year 1
The Center for Epidemiologic Studies Short Depression Scale (CES-D-10) will be used to measure depression
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Claudio Rigatto, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Aging, run by University of Manitoba 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health History (time frame: At baseline and Year 1). The study lists 29 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 25 Jun 2026.