Preventing Frailty in Hospital Through Mobilizing

NCT06802289 | Recruiting

• 1 other identifier: 102088
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Frailty management; Mobilization; Sex differences; Physical activity

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From enrollment through to the end of treatment, approximately 2 weeks

Secondary Outcomes (2)

• Hospital Length of Stay

  This will be derived at discharge of patient from the hospital (at least 3-days)

• Rate of Hospital Readmissions

  Hospital readmissions within 30 days will be quantified by medical records one-month after hospital discharge.

Study Arms (2)

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).

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).

Interventions

Mobility promotion BEHAVIORAL

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).

Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients are:
• 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.

You may not qualify if:

• Patients enrolled in other clinical trials or interventions that might confound the results of the study.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Vitalite Health Network: collaborator

Study Sites (1)

Dr. Georges-L.-Dumont University Hospital Centre

Moncton, New Brunswick, E1C 2Z3, Canada

RECRUITING

Related Publications (7)

• 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.

  PMID: 19463525 BACKGROUND

• 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.

  PMID: 31382011 BACKGROUND

• 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.

  PMID: 35180287 BACKGROUND

• 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.

  PMID: 36682711 BACKGROUND

• 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.

  PMID: 33028215 BACKGROUND

• 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.

  PMID: 37429038 BACKGROUND

• 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.

  PMID: 41453522 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Myles W O'Brien, PhD

CONTACT

(506) 863-2250; Myles.OBrien@USherbrooke.ca

Shirko Ahmadi, PhD

CONTACT

(506) 863-2250; Shirko.Ahmadi@USherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: January 31, 2025
• Study Start: January 13, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)