FrailtyPACE - OGCNCT07787663
Promoting Autonomy Through ExerCisE (PACE) in Outpatient Geriatric Clinics
A study testing PACE in people with Frailty and Sarcopenia, run by Université du Québec a Montréal at 1 site in Canada.
Trial summary
Physical inactivity is highly prevalent among older adults and is associated with declines in physical function, independence, quality of life, and social participation. The PACE tool provides 35 tailored physical activity programs for frail, community-dwelling older adults. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frailty, Sarcopenia
- What is being tested?
- PACE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteCanada
- Study dates
- 23 Mar 2021to 11 Sep 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being followed in an outpatient geriatric clinic
- Aged 60 years and older, with or without an informal caregiver
- Have the cognitive capacity to provide informed consent;
- Have no contraindications to physical activity;
- Are not currently receiving rehabilitation services;
- Are able to communicate, read, and understand French or English;
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prescribing Specific and Tailored Physical Activity to Prevent Health Declines in Frail Community-dwelling Older Adults Followed in Outpatient Geriatric Clinics : The PACE- OGC Study
Physical inactivity is highly prevalent among older adults and is associated with declines in physical function, independence, quality of life, and social participation.
The PACE tool provides 35 tailored physical activity programs for frail, community-dwelling older adults. Programs are prescribed by healthcare professionals using simple clinical criteria and can be delivered remotely. Previous research has demonstrated the feasibility, acceptability, safety, and effectiveness of adapted physical activity programs.
The main objective of the project is to implement PACE in the geriatric outpatient clinics (CEG) of the Institut Universitaire de Gériatrie de Montréal (IUGM) to prevent deconditioning, promote autonomy, and reduce the burden on caregivers and healthcare resources.
Read the detailed description
Physical inactivity (<150 minutes of physical activity (PA)/week) affects more than 75% of community-dwelling older adults, and this proportion increases to 90% among those living in residential settings. This behavior, which is the fourth leading risk factor for mortality, is also known to accelerate declines in functional capacity and physical performance. As a result, a negative cycle develops: following these declines, older adults may stop going out and become socially isolated, leading to further physical decline, reduced quality of life, and related mental health problems (stress and anxiety).
After the age of 65, older adults will spend, on average, 50% of their remaining lifetime living with physical disabilities. This loss of independence reduces their quality of life, social participation, and ability to remain at home.
These declines have consequences for home-care and healthcare systems. As a result of these declines, older adults may move into private seniors' residences (RPA; 18% in Quebec) or intermediate resources (RI; 8,817 places occupied by older adults), where levels of physical inactivity are exacerbated, increasing from 60% to 90%.
Unfortunately, the COVID-19 pandemic has exacerbated this problem, as it has forced older adults to remain at home or receive fewer home-care services due to restrictions on activities and physical/social distancing. As a result, they may remain inactive for an unknown period of time, creating a stressful situation.
One of the reasons for the high levels of physical inactivity and sedentary behavior among older adults is that the implementation of mobilizing activities is not part of routine care or service practices in outpatient geriatric clinics (OGC). Staff and managers in these settings have identified several barriers, including a lack of familiarity, human resources, knowledge, or skills related to these interventions, as well as anticipated challenges regarding the allocation of the human resources required.
Helping address the major challenge of maintaining older adults' health and preventing the accelerated deconditioning caused by isolation measures implemented to protect them from COVID-19 is a priority identified in the COVID-19 Ministerial Plan, through the Action Plan for a Second Wave, Axis 2, Action 3: prevention of deconditioning and supporting healthy aging at home.
This is precisely what this project, through the PACE tool, aims to achieve. Finally, in addition to older adults at risk, Quebec has 1.7 million informal caregivers, 58% of whom provide care to adults aged 75 and older. Unfortunately, this role is not without challenges, as caregiving is recognized as an important source of stress for caregivers who must cope with the declining health of an older adult and may consequently experience a deterioration in their own quality of life. The COVID-19 pandemic appears to have exacerbated this burden.
Previous studies conducted by our research team have shown that the implementation and use of specific and tailored PA programs are feasible, acceptable, and effective in older adults following hospitalization, resulting in improvements in walking speed, balance, and other physical outcomes. Furthermore, these studies showed that unsupervised prescription of adapted and individualized PA is not a concern, as it does not increase the risk of falls. Most importantly, for the implementation of such a practice, these programs were considered by the healthcare team to be easy to integrate into routine care/services and relevant to their mission. Their implementation was also feasible and beneficial, including in COVID-19 units.
The development of the PACE tool (Promouvoir l'Autonomie par l'exerCicE [Promoting Autonomy through Exercise]) is based on the same pragmatic and co-construction approach, incorporating the perspectives of healthcare settings through consultation with geriatric care clinicians (OGC) regarding usual practices, available resources, barriers, and limitations, as well as the perspectives of older adults and their informal caregivers regarding their expectations for PA. The tool includes 35 PA programs tailored to frail older adults who continue to live in the community. These programs are prescribed by a healthcare professional using a decision tree based on simple clinical criteria.
Furthermore, among older adults, dyadic interventions (older adult and informal caregiver) are associated with greater adherence to PA. The positive effects of PA on older adults' health can therefore be enhanced, leading to improved physical autonomy and reduced assistance requirements for informal caregivers, which is a government priority.
In addition, more than 60% of older adults and 80% of informal caregivers own connected devices such as a computer, tablet, or smartphone and regularly use the internet. Consequently, during the first wave of the COVID-19 pandemic, our research group implemented a protocol to remotely assess and monitor older adults' objective and subjective physical health in a valid and safe manner using the ZOOM© platform. Therefore, this remote, interactive virtual delivery model will not be a barrier to implementation and will make it possible to reach isolated older adults who require support.
Thus, the main objective of the project is to implement a best practice-daily prescription of adapted PA using the PACE tool in the outpatient geriatric clinics of the Institut Universitaire de Gériatrie de Montréal (IUGM) in order to counteract deconditioning while also reducing the workload on human resources.
- Conditions
- Frailty, Sarcopenia
- Being tested
- PACE
- Medical subject headings
- Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACEOther
The patient's mobility profile is determined using a decisional tree, which guides the prescription of an adapted physical activity (PA) program. The PACE tool includes 35 PA programs divided into 7 color-coded categories according to the physical components that should be prioritized (cardiorespiratory/muscular fitness, balance, and/or trunk mobility/stability). 5 difficulty levels provided. Each program includes 2 to 4 exercises (approx.15 min/day) and a walking goal ranging from 10 minutes (2 × 5 min) to 30 minutes (2 × 15 min). The program is prescribed daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| PACE Group | Experimental | Physical Activity program prescription via the PACE tool Receives: Other: PACE |
| Control Group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the PACE tool
will be measured using a score (expressed in % from 0 to 100) taking into account the ratio of the number of patients who have received a PA program prescription on the number of eligible patients.
Measured: 12 weeks
Adherence to the pace tool
will be measured using a score (expressed in % from 0 to 100) taking into account the ratio of the number of completed sessions of PA on the prescribed sessions.
Measured: 12 weeks
Usability of the PACE TOOL
Usability will be measured using the valided SUS questionnaire (10 items/score ranged from 0 to 100)
Measured: 12 weeks
Acceptability of the PACE Tool
Will be evaluated by the administration of a questionnaire with 4 Likert level/question and each likert level expressed in % (from 0 to 100).
Measured: 12 weeks
Secondary outcomes (3)
Changes in objective physical measures
SPPB score (x/12; from 0 to 12); walking speed (m/sec) ; 5 repetitions sit to stand (n); 3-meter normal Timed Up and Go (sec); 30-second chair stand (n); estimated muscle power (W).
Measured: 12 weeks
Changes in caregiver burden after intervention
using Mini-zarit Zarit Burden questionnaire (7 questions from 0 to 4; total score: X/28 (min: 0 - max: 28)
Measured: 12 weeks
Changes in the quality of life after intervention (12-Item Short Form Survey: SF-12)
12-Item Short Form Survey: SF-12 (questionnaire with 12 items; score from 0 (min) to 100 (max)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start23 Mar 2021
- Primary completion11 Sep 2025
- Study completion11 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec a Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mylène Aubertin-Leheudre, Université du Québec a Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787663
- Sponsor's protocol ID
- CER VN 20-21-06
- Acronym
- PACE - OGC
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: on demand only, without personal and sensitive data
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescribing Specific and Tailored Physical Activity to Prevent Health Declines in Frail Community-dwelling Older Adults Followed in Outpatient Geriatric Clinics : The PACE- OGC Study
- ClinicalTrials.gov ID
- NCT07787663
- Acronym / sponsor ID
- PACE - OGC / CER VN 20-21-06
- Conditions
- Frailty, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Université du Québec a MontréalUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 26 Aug 2026 (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.
Physical inactivity is highly prevalent among older adults and is associated with declines in physical function, independence, quality of life, and social participation.
The PACE tool provides 35 tailored physical activity programs for frail, community-dwelling older adults. Programs are prescribed by healthcare professionals using simple clinical criteria and can be delivered remotely. Previous research has demonstrated the feasibility, acceptability, safety, and effectiveness of adapted physical activity programs.
The main objective of the project is to implement PACE in the geriatric outpatient clinics (CEG) of the Institut Universitaire de Gériatrie de Montréal (IUGM) to prevent deconditioning, promote autonomy, and reduce the burden on caregivers and healthcare resources.
Detailed description
Physical inactivity (<150 minutes of physical activity (PA)/week) affects more than 75% of community-dwelling older adults, and this proportion increases to 90% among those living in residential settings. This behavior, which is the fourth leading risk factor for mortality, is also known to accelerate declines in functional capacity and physical performance. As a result, a negative cycle develops: following these declines, older adults may stop going out and become socially isolated, leading to further physical decline, reduced quality of life, and related mental health problems (stress and anxiety).
After the age of 65, older adults will spend, on average, 50% of their remaining lifetime living with physical disabilities. This loss of independence reduces their quality of life, social participation, and ability to remain at home.
These declines have consequences for home-care and healthcare systems. As a result of these declines, older adults may move into private seniors' residences (RPA; 18% in Quebec) or intermediate resources (RI; 8,817 places occupied by older adults), where levels of physical inactivity are exacerbated, increasing from 60% to 90%.
Unfortunately, the COVID-19 pandemic has exacerbated this problem, as it has forced older adults to remain at home or receive fewer home-care services due to restrictions on activities and physical/social distancing. As a result, they may remain inactive for an unknown period of time, creating a stressful situation.
One of the reasons for the high levels of physical inactivity and sedentary behavior among older adults is that the implementation of mobilizing activities is not part of routine care or service practices in outpatient geriatric clinics (OGC). Staff and managers in these settings have identified several barriers, including a lack of familiarity, human resources, knowledge, or skills related to these interventions, as well as anticipated challenges regarding the allocation of the human resources required.
Helping address the major challenge of maintaining older adults' health and preventing the accelerated deconditioning caused by isolation measures implemented to protect them from COVID-19 is a priority identified in the COVID-19 Ministerial Plan, through the Action Plan for a Second Wave, Axis 2, Action 3: prevention of deconditioning and supporting healthy aging at home.
This is precisely what this project, through the PACE tool, aims to achieve. Finally, in addition to older adults at risk, Quebec has 1.7 million informal caregivers, 58% of whom provide care to adults aged 75 and older. Unfortunately, this role is not without challenges, as caregiving is recognized as an important source of stress for caregivers who must cope with the declining health of an older adult and may consequently experience a deterioration in their own quality of life. The COVID-19 pandemic appears to have exacerbated this burden.
Previous studies conducted by our research team have shown that the implementation and use of specific and tailored PA programs are feasible, acceptable, and effective in older adults following hospitalization, resulting in improvements in walking speed, balance, and other physical outcomes. Furthermore, these studies showed that unsupervised prescription of adapted and individualized PA is not a concern, as it does not increase the risk of falls. Most importantly, for the implementation of such a practice, these programs were considered by the healthcare team to be easy to integrate into routine care/services and relevant to their mission. Their implementation was also feasible and beneficial, including in COVID-19 units.
The development of the PACE tool (Promouvoir l'Autonomie par l'exerCicE [Promoting Autonomy through Exercise]) is based on the same pragmatic and co-construction approach, incorporating the perspectives of healthcare settings through consultation with geriatric care clinicians (OGC) regarding usual practices, available resources, barriers, and limitations, as well as the perspectives of older adults and their informal caregivers regarding their expectations for PA. The tool includes 35 PA programs tailored to frail older adults who continue to live in the community. These programs are prescribed by a healthcare professional using a decision tree based on simple clinical criteria.
Furthermore, among older adults, dyadic interventions (older adult and informal caregiver) are associated with greater adherence to PA. The positive effects of PA on older adults' health can therefore be enhanced, leading to improved physical autonomy and reduced assistance requirements for informal caregivers, which is a government priority.
In addition, more than 60% of older adults and 80% of informal caregivers own connected devices such as a computer, tablet, or smartphone and regularly use the internet. Consequently, during the first wave of the COVID-19 pandemic, our research group implemented a protocol to remotely assess and monitor older adults' objective and subjective physical health in a valid and safe manner using the ZOOM© platform. Therefore, this remote, interactive virtual delivery model will not be a barrier to implementation and will make it possible to reach isolated older adults who require support.
Thus, the main objective of the project is to implement a best practice-daily prescription of adapted PA using the PACE tool in the outpatient geriatric clinics of the Institut Universitaire de Gériatrie de Montréal (IUGM) in order to counteract deconditioning while also reducing the workload on human resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PACE Group | Experimental | Other: PACEPhysical Activity program prescription via the PACE tool |
| Control Group | No intervention | –Usual care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- being followed in an outpatient geriatric clinic
- Aged 60 years and older, with or without an informal caregiver
- Have the cognitive capacity to provide informed consent;
- Have no contraindications to physical activity;
- Are not currently receiving rehabilitation services;
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| PACEThe patient's mobility profile is determined using a decisional tree, which guides the prescription of an adapted physical activity (PA) program. The PACE tool includes 35 PA programs divided into 7 color-coded categories according to the physical components that should be prioritized (cardiorespiratory/muscular fitness, balance, and/or trunk mobility/stability). 5 difficulty levels provided. Each program includes 2 to 4 exercises (approx.15 min/day) and a walking goal ranging from 10 minutes (2 × 5 min) to 30 minutes (2 × 15 min). The program is prescribed daily for 12 weeks. | Other | PACE Group |
Primary outcome
Feasibility of the PACE tool
Time frame: 12 weeks
will be measured using a score (expressed in % from 0 to 100) taking into account the ratio of the number of patients who have received a PA program prescription on the number of eligible patients.
Adherence to the pace tool
Time frame: 12 weeks
will be measured using a score (expressed in % from 0 to 100) taking into account the ratio of the number of completed sessions of PA on the prescribed sessions.
Usability of the PACE TOOL
Time frame: 12 weeks
Usability will be measured using the valided SUS questionnaire (10 items/score ranged from 0 to 100)
Acceptability of the PACE Tool
Time frame: 12 weeks
Will be evaluated by the administration of a questionnaire with 4 Likert level/question and each likert level expressed in % (from 0 to 100).
3 secondary outcomes
Changes in objective physical measures
Time frame: 12 weeks
Changes in caregiver burden after intervention
Time frame: 12 weeks
Changes in the quality of life after intervention (12-Item Short Form Survey: SF-12)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Yes. on demand only, without personal and sensitive data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACE in people with Frailty and Sarcopenia, run by Université du Québec a 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 26 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of the PACE tool (time frame: 12 weeks). The study lists 4 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 26 Aug 2026.