Preventing Frailty in Hospital Through Mobilizing

Official title

Preventing Frailty in Hospital Through Mobilizing Patients: A Pilot RCT

Overview

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.

Interventions

• Behavioral Mobility promotion
  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 vis

Primary outcome measures

• Severity of Frailty [Time frame: 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]

Secondary outcome measures (2)

• 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Health services research

Study locations

Canada · 1 center

• Dr. Georges-L.-Dumont University Hospital Centre — Moncton

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. PMID 19463525
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06802289 · 102088

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗