NCT03361891

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 volunteer coaches, 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 coach will have reduced length-of-stay in hospital and decreased likelihood of readmission. Finally, as shown in other programs trialing health coaches, the investigators anticipate an overall improvement in the patient experience. Our aim is to demonstrate the feasibility of an intentional walking protocol called WalkMORE, which pairs trained volunteer coaches with ambulatory patients admitted to the Internal Medicine unit (4th floor University Hospital), aimed at decreasing deconditioning through increased walking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 27, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

June 6, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2019

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

November 27, 2017

Last Update Submit

March 13, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient Recruitment

    Ability to recruit sufficient number of patients

    3 months

Secondary Outcomes (1)

  • Patient Safety

    6 months

Study Arms (2)

Control

NO INTERVENTION

Patients receive no intervention

WalkMORE group

EXPERIMENTAL

WalkMORE Ambulation program. 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.

Behavioral: WalkMORE Group

Interventions

WalkMORE GroupBEHAVIORAL

Hospitalized Internal Medicine patients will walk with trained volunteer coaches 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 by the health care team at time of admission
  • Cognitively safe for participation
  • Anticipated to remain hospitalized ≥48 hours
  • 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.
  • Patients that are non-English speaking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LHSC-University Hospital

London, Ontario, N6A 5A5, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
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

November 27, 2017

First Posted

December 5, 2017

Study Start

June 6, 2018

Primary Completion

December 10, 2018

Study Completion

January 9, 2019

Last Updated

March 15, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations