Frailty at Older AdultsNCT06802289
Preventing Frailty in Hospital Through Mobilizing
A study testing Mobility promotion in people with Frailty at Older Adults, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Frailty describes the variability in aging and explains why two people of the same chronological age may look very different. Higher frailty leads to poor quality of life, disability, and death. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Frailty at Older Adults
- What is being tested?
- Mobility promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 13 Jan 2025to 30 Aug 2026
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients are:
- 50 years or older,
- projected to be in-hospital for at least 3-days,
- not in a shared room with another study participant, and
- can independently provide consent or have a caregiver to provide consent.
Who cannot join
- Patients enrolled in other clinical trials or interventions that might confound the results of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Dr. Georges-L.-Dumont University Hospital Centre
Moncton, New Brunswick, E1C 2Z3
Myles W O'Brien, PhD, 902301-2523, myles.obrien@usherbrooke.ca
About this study
Official title: Preventing Frailty in Hospital Through Mobilizing Patients: A Pilot RCT
Frailty describes the variability in aging and explains why two people of the same chronological age may look very different. Higher frailty leads to poor quality of life, disability, and death. Hospitalized patients living with frailty have a higher risk for functional decline, new impairments in activities of daily living, a longer hospital stay, hospital readmission, and death. A previous study from our team has reported that 60% of inpatients have more difficulty with 1+ basic activity of daily living (i.e., eating, getting out of bed, using the toilet, etc.) after hospitalization compared to pre-admission, with 1-in-4 patients having difficulty with 3+ basic tasks. Patients with few health deficits can recover to their pre-admission level, but those with higher frailty levels cannot, priming them for readmissions. Physical activity and reducing time spent sitting or lying postures prevent and improve frailty. Older patients who walk at least once/day outside their room during hospitalization have ~1.7 days shorter length of hospital stay compared with those who stayed in their room. Although multiple barriers exist to promoting upright time in a hospital, strategies that help address patients' excessive time spent in bed are often not implemented but could attenuate the development of frailty in the hospital. Few exercise interventions in hospital studies have considered frailty. The investigators have conducted a clinical trial within the Halifax Infirmary (Nova Scotia Health) that focused on mobilizing patients (average age: ~75 years) via regular visits by a Kinesiologist and observed that the intervention groups reduced their frailty level from preadmission and admission versus discharge. While preliminary findings from this model were promising, its reach was limited to acute geriatric care and dependent upon researchers to conduct the intervention. At the Georges-L. Dumont hospital, a patient mobilization program has been introduced in General and Internal Medicine (floor 4C) that embedded Kinesiologists within care to visit patients daily. Preliminary findings indicate that patients and staff are enjoying the program via self-report questionnaire. However, evaluations of the program's effectiveness in changing objectively measured activity and frailty levels and whether multiple patient visits would be more effective (e.g., refining the program) are unclear. The investigators propose to evaluate the effectiveness of the existing patient mobilization program and if more patient contact improves outcomes. Our study integrates activity monitoring technology and frailty assessments to help patients leave the hospital healthier and decrease the risk of readmission. Study Objectives: The proposed study will test the hypothesis that, compared to usual care (Kinesiology visit once/day), patients who receive multiple check-ins will, 1) increase their step counts and upright time, 2) decrease their frailty level, and 3) have a less length of stay and less readmission rates.
- Conditions
- Frailty at Older Adults
- Being tested
- Mobility promotion
- Keywords
- Frailty management, Mobilization, Sex differences, Physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobility promotionBehavioural
At the Georges-L. Dumont hospital, a patient mobilization program has been introduced on floor 4C that embeds Kinesiologists within care to visit patients daily. A team of Kinesiologists visit the patients daily to promote movement and help them mobilize to the best of their capabilities (e.g., walking, standing, or sitting on the edge of the bed). One visit daily is considered usual care. The investigators propose to continue this individualized model but incorporate at least one additional visit from the kinesiologist to test if this imporves activity and frailty compared to usual care (one daily visit).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A team of Kinesiologists visit the patients at least twice daily from admission to discharge to promote movement and help them mobilize to the best of their capabilities (e.g., walking, standing, or sitting on the edge of the bed). Receives: Behavioral: Mobility promotion |
| Usual Care Control | No intervention | A team of Kinesiologists visit the patients once daily from admission to discharge to promote movement and help them mobilize to the best of their capabilities (e.g., walking, standing, or sitting on the edge of the bed). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Frailty
Frailty will be assessed in each participant using the validated Frailty Index used extensively by our group, which calculates frailty as a proportion of health problems present in each person. A trained researcher will help the patient complete the Frailty Index and measure participants' frailty using the Clinical Frailty Scale (scored from 1 [very fit] to 9 [terminally ill]). This scale ensures us a way to obtain a graded frailty score for participants who might be unable to complete the longer questionnaire with assistance.
Measured: At enrollment and at the end of treatment, approximately 2 weeks
Accumulation of Physical Activity & Postures in Hospital
Movement will be measured using activPAL inclinometers positioned on the patients' torso, thigh, and shin. Monitors will be waterproofed and attached 24-hr/day for at least 3-days using a clear medical dressing. We have safely attached these devices to patients' skin for longer durations (14+ days). Physical activity (step counts, physical activity intensity), upright posture, and detailed sedentary postures (e.g., sitting versus lying time) will be determined via validated, custom software that was developed and openly published by our group.
Measured: From enrollment through to the end of treatment, approximately 2 weeks
Secondary outcomes (2)
Hospital Length of Stay
Measured: This will be derived at discharge of patient from the hospital (at least 3-days)
Rate of Hospital Readmissions
Measured: Hospital readmissions within 30 days will be quantified by medical records one-month after hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start13 Jan 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Frailty at Older AdultsStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Vitalite Health Network
- Responsible party
- Principal investigator, Myles William O'Brien, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802289
- Sponsor's protocol ID
- 102088
- Status last verified
- Apr 2026
- First submitted
- 21 Nov 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to concerns related to participant confidentiality and privacy. As a result, we have decided not to make the data publicly available.
Publications
Afilalo J, Karunananthan S, Eisenberg MJ, Alexander KP, Bergman H. Role of frailty in patients with cardiovascular disease. Am J Cardiol. 2009 Jun 1;103(11):1616-21. doi: 10.1016/j.amjcard.2009.01.375. Epub 2009 Apr 8.
PubMed 19463525Theou O, Kehler DS, Godin J, Mallery K, MacLean MA, Rockwood K. Upright time during hospitalization for older inpatients: A prospective cohort study. Exp Gerontol. 2019 Oct 15;126:110681. doi: 10.1016/j.exger.2019.110681. Epub 2019 Aug 2.
PubMed 31382011Perez-Zepeda MU, Martinez-Velilla N, Kehler DS, Izquierdo M, Rockwood K, Theou O. The impact of an exercise intervention on frailty levels in hospitalised older adults: secondary analysis of a randomised controlled trial. Age Ageing. 2022 Feb 2;51(2):afac028. doi: 10.1093/ageing/afac028.
PubMed 35180287O'Brien MW, Kimmerly DS, Theou O. Impact of age and sex on the relationship between carotid intima-media thickness and frailty level in the Canadian Longitudinal Study of Aging. J Cardiol. 2023 Aug;82(2):140-145. doi: 10.1016/j.jjcc.2023.01.004. Epub 2023 Jan 20.
PubMed 36682711Church S, Rogers E, Rockwood K, Theou O. A scoping review of the Clinical Frailty Scale. BMC Geriatr. 2020 Oct 7;20(1):393. doi: 10.1186/s12877-020-01801-7.
PubMed 33028215O'Brien MW, Schwartz BD, Shivgulam ME, Daley WS, Frayne RJ, Kimmerly DS. Higher habitual lying time is inversely associated with vagal-related heart rate variability outcomes in younger adults. Appl Physiol Nutr Metab. 2023 Nov 1;48(11):876-881. doi: 10.1139/apnm-2023-0167. Epub 2023 Jul 10.
PubMed 37429038Shivgulam ME, Dumont M, Ahmadi S, Courish M, Barrieau L, Cormier L, Theou O, Mekari S, O'Brien MW. Kinesiologist-delivered mobilization to mitigate inpatient frailty: A study protocol for a randomized controlled trial. Contemp Clin Trials. 2026 Feb;161:108204. doi: 10.1016/j.cct.2025.108204. Epub 2025 Dec 24.
PubMed 41453522
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Frailty in Hospital Through Mobilizing Patients: A Pilot RCT
- ClinicalTrials.gov ID
- NCT06802289
- Acronym / sponsor ID
- 102088
- Conditions
- Frailty at Older Adults
- Keywords
- Frailty management, Mobilization, Sex differences, Physical activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Vitalite Health Network
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 31 Jan 2025 (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.
Frailty describes the variability in aging and explains why two people of the same chronological age may look very different. Higher frailty leads to poor quality of life, disability, and death. Hospitalized patients living with frailty have a higher risk for functional decline, new impairments in activities of daily living, a longer hospital stay, hospital readmission, and death. A previous study from our team has reported that 60% of inpatients have more difficulty with 1+ basic activity of daily living (i.e., eating, getting out of bed, using the toilet, etc.) after hospitalization compared to pre-admission, with 1-in-4 patients having difficulty with 3+ basic tasks. Patients with few health deficits can recover to their pre-admission level, but those with higher frailty levels cannot, priming them for readmissions. Physical activity and reducing time spent sitting or lying postures prevent and improve frailty. Older patients who walk at least once/day outside their room during hospitalization have ~1.7 days shorter length of hospital stay compared with those who stayed in their room. Although multiple barriers exist to promoting upright time in a hospital, strategies that help address patients' excessive time spent in bed are often not implemented but could attenuate the development of frailty in the hospital. Few exercise interventions in hospital studies have considered frailty. The investigators have conducted a clinical trial within the Halifax Infirmary (Nova Scotia Health) that focused on mobilizing patients (average age: ~75 years) via regular visits by a Kinesiologist and observed that the intervention groups reduced their frailty level from preadmission and admission versus discharge. While preliminary findings from this model were promising, its reach was limited to acute geriatric care and dependent upon researchers to conduct the intervention. At the Georges-L. Dumont hospital, a patient mobilization program has been introduced in General and Internal Medicine (floor 4C) that embedded Kinesiologists within care to visit patients daily. Preliminary findings indicate that patients and staff are enjoying the program via self-report questionnaire. However, evaluations of the program's effectiveness in changing objectively measured activity and frailty levels and whether multiple patient visits would be more effective (e.g., refining the program) are unclear. The investigators propose to evaluate the effectiveness of the existing patient mobilization program and if more patient contact improves outcomes. Our study integrates activity monitoring technology and frailty assessments to help patients leave the hospital healthier and decrease the risk of readmission. Study Objectives: The proposed study will test the hypothesis that, compared to usual care (Kinesiology visit once/day), patients who receive multiple check-ins will, 1) increase their step counts and upright time, 2) decrease their frailty level, and 3) have a less length of stay and less readmission rates.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mobility promotionA team of Kinesiologists visit the patients at least twice daily from admission to discharge to promote movement and help them mobilize to the best of their capabilities (e.g., walking, standing, or sitting on the edge of the bed). |
| Usual Care Control | No intervention | –A team of Kinesiologists visit the patients once daily from admission to discharge to promote movement and help them mobilize to the best of their capabilities (e.g., walking, standing, or sitting on the edge of the bed). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 50 years or older,
- projected to be in-hospital for at least 3-days,
- not in a shared room with another study participant, and
- can independently provide consent or have a caregiver to provide consent.
Key exclusion criteria (1 listed)
- Patients enrolled in other clinical trials or interventions that might confound the results 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobility promotionAt the Georges-L. Dumont hospital, a patient mobilization program has been introduced on floor 4C that embeds Kinesiologists within care to visit patients daily. A team of Kinesiologists visit the patients daily to promote movement and help them mobilize to the best of their capabilities (e.g., walking, standing, or sitting on the edge of the bed). One visit daily is considered usual care. The investigators propose to continue this individualized model but incorporate at least one additional visit from the kinesiologist to test if this imporves activity and frailty compared to usual care (one daily visit). | Behavioural | Intervention |
Primary outcome
Severity of Frailty
Time frame: At enrollment and at the end of treatment, approximately 2 weeks
Frailty will be assessed in each participant using the validated Frailty Index used extensively by our group, which calculates frailty as a proportion of health problems present in each person. A trained researcher will help the patient complete the Frailty Index and measure participants' frailty using the Clinical Frailty Scale (scored from 1 [very fit] to 9 [terminally ill]). This scale ensures us a way to obtain a graded frailty score for participants who might be unable to complete the longer questionnaire with assistance.
Accumulation of Physical Activity & Postures in Hospital
Time frame: From enrollment through to the end of treatment, approximately 2 weeks
Movement will be measured using activPAL inclinometers positioned on the patients' torso, thigh, and shin. Monitors will be waterproofed and attached 24-hr/day for at least 3-days using a clear medical dressing. We have safely attached these devices to patients' skin for longer durations (14+ days). Physical activity (step counts, physical activity intensity), upright posture, and detailed sedentary postures (e.g., sitting versus lying time) will be determined via validated, custom software that was developed and openly published by our group.
2 secondary outcomes
Hospital Length of Stay
Time frame: This will be derived at discharge of patient from the hospital (at least 3-days)
Rate of Hospital Readmissions
Time frame: Hospital readmissions within 30 days will be quantified by medical records one-month after hospital discharge.
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 29 Apr 2026.
- Background: PubMed 19463525Afilalo J, Karunananthan S, Eisenberg MJ, Alexander KP, Bergman H. Role of frailty in patients with cardiovascular disease. Am J Cardiol. 2009 Jun 1;103(11):1616-21. doi: 10.1016/j.amjcard.2009.01.375. Epub 2009 Apr 8.
- Background: PubMed 31382011Theou O, Kehler DS, Godin J, Mallery K, MacLean MA, Rockwood K. Upright time during hospitalization for older inpatients: A prospective cohort study. Exp Gerontol. 2019 Oct 15;126:110681. doi: 10.1016/j.exger.2019.110681. Epub 2019 Aug 2.
- Background: PubMed 35180287Perez-Zepeda MU, Martinez-Velilla N, Kehler DS, Izquierdo M, Rockwood K, Theou O. The impact of an exercise intervention on frailty levels in hospitalised older adults: secondary analysis of a randomised controlled trial. Age Ageing. 2022 Feb 2;51(2):afac028. doi: 10.1093/ageing/afac028.
- Background: PubMed 36682711O'Brien MW, Kimmerly DS, Theou O. Impact of age and sex on the relationship between carotid intima-media thickness and frailty level in the Canadian Longitudinal Study of Aging. J Cardiol. 2023 Aug;82(2):140-145. doi: 10.1016/j.jjcc.2023.01.004. Epub 2023 Jan 20.
- Background: PubMed 33028215Church S, Rogers E, Rockwood K, Theou O. A scoping review of the Clinical Frailty Scale. BMC Geriatr. 2020 Oct 7;20(1):393. doi: 10.1186/s12877-020-01801-7.
- Background: PubMed 37429038O'Brien MW, Schwartz BD, Shivgulam ME, Daley WS, Frayne RJ, Kimmerly DS. Higher habitual lying time is inversely associated with vagal-related heart rate variability outcomes in younger adults. Appl Physiol Nutr Metab. 2023 Nov 1;48(11):876-881. doi: 10.1139/apnm-2023-0167. Epub 2023 Jul 10.
- Derived from this study: PubMed 41453522Shivgulam ME, Dumont M, Ahmadi S, Courish M, Barrieau L, Cormier L, Theou O, Mekari S, O'Brien MW. Kinesiologist-delivered mobilization to mitigate inpatient frailty: A study protocol for a randomized controlled trial. Contemp Clin Trials. 2026 Feb;161:108204. doi: 10.1016/j.cct.2025.108204. Epub 2025 Dec 24.
- Individual participant dataSharing planned: No. IPD will not be shared due to concerns related to participant confidentiality and privacy. As a result, we have decided not to make the data publicly available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobility promotion in people with Frailty at Older Adults, run by Université de Sherbrooke 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 5 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: looking for participants now, as of the sponsor's last update on 29 Apr 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?
Contact Myles W O'Brien, PhD ((506) 863-2250, Myles.OBrien@USherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Frailty (time frame: At enrollment and at the end of treatment, approximately 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06802289, which also lists 7 linked publications.
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 29 Apr 2026.