- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06802289
Preventing Frailty in Hospital Through Mobilizing
April 28, 2026 updated by: Myles William O'Brien, Université de Sherbrooke
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Myles W O'Brien, PhD
- Phone Number: (506) 863-2250
- Email: Myles.OBrien@USherbrooke.ca
Study Contact Backup
- Name: Shirko Ahmadi, PhD
- Phone Number: (506) 863-2250
- Email: Shirko.Ahmadi@USherbrooke.ca
Study Locations
-
-
New Brunswick
-
Moncton, New Brunswick, Canada, E1C 2Z3
- Recruiting
- Dr. Georges-L.-Dumont University Hospital Centre
-
Contact:
- Myles W O'Brien, PhD
- Phone Number: 902301-2523
- Email: myles.obrien@usherbrooke.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- Patients enrolled in other clinical trials or interventions that might confound the results of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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).
|
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).
|
|
No Intervention: Usual Care Control
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At enrollment and at the end of treatment, approximately 2 weeks
|
|
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.
|
From enrollment through to the end of treatment, approximately 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hospital Length of Stay
Time Frame: This will be derived at discharge of patient from the hospital (at least 3-days)
|
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.
|
Hospital readmissions within 30 days will be quantified by medical records one-month after hospital discharge.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Theou 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.
- Perez-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.
- O'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.
- Church 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.
- O'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.
- Shivgulam 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 13, 2025
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
August 30, 2026
Study Registration Dates
First Submitted
November 21, 2024
First Submitted That Met QC Criteria
January 29, 2025
First Posted (Actual)
January 31, 2025
Study Record Updates
Last Update Posted (Actual)
April 29, 2026
Last Update Submitted That Met QC Criteria
April 28, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102088
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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