Preventing Frailty in Hospital Through Mobilizing
Preventing Frailty in Hospital Through Mobilizing Patients: A Pilot RCT
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
Sponsor
Sponsor
Collaborators
Collaborators
Publications and helpful links
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
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 102088
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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