NCT03888027

Brief Summary

Patients admitted to hospital typically experience periods of decreased activity or bed-rest. This reduced activity level leads to deconditioning - a loss of muscle mass, muscle strength (by 2-5% per day), and muscle shortening. Even among patients who were ambulatory at the time of admission, deconditioning has been linked with deleterious effects, such as increased rates of falls, functional decline, and frailty. Furthermore, it has been suggested that the physiological stresses associated with hospitalization - including deconditioning, as well as sleep deprivation and poor nutrition - makes discharged patients vulnerable to recurrent or new illnesses and to frailty. This physiological stress-induced vulnerability has been coined "post-hospital syndrome" and is thought to have a role in most hospital readmissions. The investigators hypothesize that by engaging ambulatory patients to walk with trained volunteers, patients will increase their amount of walking, have less deconditioning and functional decline, and consequently, fewer falls. Furthermore, the investigators anticipate that patients who walk with a trained volunteer will have reduced length-of-stay in hospital and decreased likelihood of readmission. Finally, as shown in other similar programs, the investigators anticipate an overall improvement in the patient experience. The investigator's novel initiative focuses on a single, volunteer-based intentional ambulation program that can deliver the benefits of early mobility in a cost-effective way. The program design engages trained volunteers to increase patient ambulation in a way that both increases patient mobility and reduces healthcare professionals' workload.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 6, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2026

Completed
Last Updated

October 15, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

March 13, 2019

Last Update Submit

October 10, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Re-hospitalization

    Number of patients re-admitted to hospital

    30 days after randomization

  • Presentation to emergency department

    Number of patients seen in the hospital emergency department

    30 days after randomization

  • Prolonged index hospital admission

    Number of patients with extended length of hospital admission

    30 days after randomization

Secondary Outcomes (8)

  • Length of stay for index hospital admission

    30 days after randomization

  • Post-discharge Falls

    30 days after randomization

  • Timed-Up-And-Go

    30 days after randomization

  • Barthel Index

    30 days after randomization

  • Frailty

    30 days after randomization

  • +3 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Patients receive no intervention

WalkMORE group

ACTIVE COMPARATOR

Patients will be randomized via REDCap (Research Electronic Data Capture), a secure, centralized web-based randomization module to: 1. Standard of care; or 2. WalkMORE Ambulation program + Standard of care. Patients will ambulate with a trained WalkMORE volunteer two times per day; once in the morning (0900-1200hrs) and once in the afternoon (1300-1700hrs), Monday- Friday, until hospital discharge. Patients randomized to the WalkMORE intervention will be assessed daily by the Research Coordinator to ensure patients remain fit for independent ambulation. The duration of each walking session will be determined daily by the RC and the medical team.

Behavioral: WalkMORE group

Interventions

WalkMORE groupBEHAVIORAL

Hospitalized Internal Medicine patients will walk with trained volunteers twice daily until hospital discharge.

WalkMORE group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Capable and appropriate for independent ambulation (with or without gait aids) as determined daily by the health care team
  • Cognitively safe for participation
  • Anticipated to remain hospitalized ≥48 hours
  • Inpatient, admitted to Internal Medicine at University Hospital
  • Age \>18 years

You may not qualify if:

  • Preexisting condition precludes patient from independent ambulation at time of admission
  • Active medical condition precludes patient from safely participating
  • Preexisting condition or active medical condition renders patient unfit to participate as judged by the admitting team
  • Patients who refuse to participate or are unable to provide informed consent.
  • Communication barrier (due to hearing/vision impairment, or language barrier)
  • Patients receiving treatment from an LHSC inpatient Physiotherapist.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LHSC-University Hospital

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Patients will be randomized via REDCap (Research Electronic Data Capture), a secure, centralized web-based randomization module to: 1. Standard of care; or 2. WalkMORE Ambulation program + Standard of care. Patients will ambulate with a trained WalkMORE Volunteer Coach two times per day; once in the morning (0900-1200hrs) and once in the afternoon (1300-1700hrs), Monday- Friday, until hospital discharge. Patients randomized to the WalkMORE intervention will be assessed daily by the Research Coordinator to ensure patients remain fit for independent ambulation. The duration of each walking session will be determined daily by the RC and the medical team.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 25, 2019

Study Start

May 6, 2019

Primary Completion

March 13, 2020

Study Completion

March 13, 2026

Last Updated

October 15, 2024

Record last verified: 2024-03

Locations