An interventional study of PACE in Frailty and Sarcopenia, sponsored by Université du Québec a Montréal. Completed at 1 site in Canada. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Université du Québec a Montréal · Not applicable, Interventional, and Treatment
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.
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.
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
This study's enrollment of 162 is above the median of 81 across 767 interventional studies indexed under Frailty.
Browse Frailty studies →Université du Québec a Montréal is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Physical Activity program prescription via the PACE tool
Other: PACE
Usual care
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.
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.
Time frame: 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.
Time frame: 12 weeks
Usability of the PACE TOOL
Usability will be measured using the valided SUS questionnaire (10 items/score ranged from 0 to 100)
Time frame: 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).
Time frame: 12 weeks
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).
Time frame: 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)
Time frame: 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)
Time frame: 12 weeks
Plan to share: Yes — on demand only, without personal and sensitive data
No publications or documents are linked to this record.
Ran from Mar 2021 to primary completion in Sep 2025, 53 months.
Of 513 non-industry interventional studies with no phase under Frailty, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's 53 months is above that.
Counting every sponsor, half of 517 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Université du Québec a Montréal