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Clinical Trials/NCT06802289
NCT06802289
Recruiting
Not Applicable

Preventing Frailty in Hospital Through Mobilizing Patients: A Pilot RCT

Université de Sherbrooke2 sites in 1 country80 target enrollmentStarted: January 13, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
80
Locations
2
Primary Endpoint
Severity of Frailty

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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).

Intervention: Mobility promotion (Behavioral)

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).

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Myles William O'Brien

Dr.

Université de Sherbrooke

Study Sites (2)

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