FrailtyWalkMORENCT03888027
WalkMORE: A Volunteer-driven Walking Intervention
A study testing WalkMORE group in people with Frailty and Deconditioning, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frailty, Deconditioning, Early Ambulation
- What is being tested?
- WalkMORE group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteCanada
- Study dates
- 6 May 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of a Volunteer-driven Walking Intervention to Improve Hospital-associated Deconditioning and Frailty
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.
Read the detailed description
WalkMORE is a single-center randomized controlled trial. The investigators will enroll up to 800 ambulatory patients admitted to the Internal Medicine unit (located on the 4th floor of University Hospital) who are >18 years of age and are anticipated to require a >48 hour hospital admission. A maximum of 6 patients will be assigned to each treatment arm at any given time. The investigators will recruit patients into the WalkMORE program over a 2 year period. The research coordinator (RC) will screen patients admitted to the Internal Medicine unit in the preceding 24-hour period to identify patients who fulfill the eligibility criteria. Patients will be randomized via REDCap (Research Electronic Data Capture), a secure, centralized web-based randomization module to:
- Standard of care; or
- WalkMORE Ambulation program + Standard of care. Patients will ambulate with a trained WalkMORE Volunteer two times per day; once in the morning (0900-1200 hrs) and once in the afternoon (1300-1600 hrs), Monday- Friday, until hospital discharge. Patients randomized to the WalkMORE intervention will be assessed daily by the RC 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.
After obtaining written informed consent from eligible patients the RC will randomize patients, collect demographics and hospital admission details from patients' hospital charts and perform the Barthel Index and complete the Charlson Comorbidity Index (CCI) for all patients. The Barthel Index (BI) measures the extent to which patients can function independently and has mobility in their activities of daily living (ADL). The Charlson Comorbidity Index categorizes and scores the comorbidities of patients. The CCI can be used to predict short term and long-term outcomes such as function, hospital length of stay and mortality rates. The CCI will be completed using information gathered from patients' hospital chart.with all patients.
All patients will be assigned a scientific pedometer on the day of randomization. The modus Health StepWatch™ is an activity monitor worn on the ankle via a velcro strap. It is a small, lightweight device that will count and record patients' steps throughout hospital stay, ending at hospital discharge. Research personnel will be responsible for fitting the StepWatch monitor to patients' ankle. The device is smaller than a deck of cards (7.5 x 5.0 x 2.0 cm) and weighs 38 grams.
Frailty and de-conditioning will be measured on Study Day 3. Frailty will be assessed using the Jamar Hand Dynamometer. Patients are instructed to squeeze the handle of the instrument with their maximum force for three seconds; the peak-hold (in kilograms) is recorded on the instrument. Three successive peak-hold measurements will be recorded. The device measures 10 x 20 x 33cm and weighs 1.3 kg. Deconditioning will be measured using the Timed Up and Go (TUG) test, patients will be asked to stand up from a chair, walk three metres, turn around, and walk back to the chair and sit.
After hospital discharge the RC will follow up with patients for 2 brief telephone interviews. On the third day after discharge, Patient Satisfaction surveys will be conducted by the RC to assess patient satisfaction with their hospital experience and with the WalkMORE program. On day 30 after randomization, the RC will contact patients to conduct a brief interview consisting of: a health status survey (EQ-5D), a functional status assessment (Barthel Index) and to collect data regarding clinical outcomes (ER visits, re-hospitalizations, and falls). Each telephone interview is expected to last approximately 10 minutes.
- Conditions
- Frailty, Deconditioning, Early Ambulation
- Being tested
- WalkMORE group
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkMORE groupBehavioural
Hospitalized Internal Medicine patients will walk with trained volunteers twice daily until hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: WalkMORE group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-hospitalization
Number of patients re-admitted to hospital
Measured: 30 days after randomization
Presentation to emergency department
Number of patients seen in the hospital emergency department
Measured: 30 days after randomization
Prolonged index hospital admission
Number of patients with extended length of hospital admission
Measured: 30 days after randomization
Secondary outcomes (8)
Length of stay for index hospital admission
Number of days patient was hospitalized
Measured: 30 days after randomization
Post-discharge Falls
Composite of number of readmissions and emergency room visits secondary to patients experiencing a fall post-discharge
Measured: 30 days after randomization
Timed-Up-And-Go
Measure of de-conditioning between the two study arms using
Measured: 30 days after randomization
Barthel Index
ordinal scale used to measure performance in activities of daily living. Minimum score is zero and maximum score is 100, higher score represent better outcomes.
Measured: 30 days after randomization
Frailty
Measure of frailty between the two study arms using the Jamar Hand Dynamometer data
Measured: 30 days after randomization
Deconditioning
total steps as measured by pedometer as a measure of deconditioning
Measured: 30 days after randomization
Increased number of steps
proportion of patients who increase step count by 200 steps per day
Measured: 30 days after randomization
EQ-5D
A STANDARDIZED INSTRUMENT FOR USE AS A MEASURE OF HEALTH OUTCOME. The EQ-VAS scale ranges from a minimum of zero and a maximum of 100 and is the participants subjective score of how good or poor their health is at the time the scale is presented to them. Higher values represent a better outcome
Measured: 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start6 May 2019
- Primary completion13 Mar 2020
- Study completion31 Dec 2026 (estimated)
Why it stopped: COVID-19 prevented volunteers from entering and interacting with patients. The study intervention was reliant on volunteers engaging directly with participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888027
- Sponsor's protocol ID
- ReDA 6072
- Acronym
- WalkMORE
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2019
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Volunteer-driven Walking Intervention to Improve Hospital-associated Deconditioning and Frailty
- ClinicalTrials.gov ID
- NCT03888027
- Acronym / sponsor ID
- WalkMORE / ReDA 6072
- Conditions
- Frailty, Deconditioning, Early Ambulation
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID-19 prevented volunteers from entering and interacting with patients. The study intervention was reliant on volunteers engaging directly with participants.
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
WalkMORE is a single-center randomized controlled trial. The investigators will enroll up to 800 ambulatory patients admitted to the Internal Medicine unit (located on the 4th floor of University Hospital) who are >18 years of age and are anticipated to require a >48 hour hospital admission. A maximum of 6 patients will be assigned to each treatment arm at any given time. The investigators will recruit patients into the WalkMORE program over a 2 year period. The research coordinator (RC) will screen patients admitted to the Internal Medicine unit in the preceding 24-hour period to identify patients who fulfill the eligibility criteria. Patients will be randomized via REDCap (Research Electronic Data Capture), a secure, centralized web-based randomization module to:
- Standard of care; or
- WalkMORE Ambulation program + Standard of care. Patients will ambulate with a trained WalkMORE Volunteer two times per day; once in the morning (0900-1200 hrs) and once in the afternoon (1300-1600 hrs), Monday- Friday, until hospital discharge. Patients randomized to the WalkMORE intervention will be assessed daily by the RC 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.
After obtaining written informed consent from eligible patients the RC will randomize patients, collect demographics and hospital admission details from patients' hospital charts and perform the Barthel Index and complete the Charlson Comorbidity Index (CCI) for all patients. The Barthel Index (BI) measures the extent to which patients can function independently and has mobility in their activities of daily living (ADL). The Charlson Comorbidity Index categorizes and scores the comorbidities of patients. The CCI can be used to predict short term and long-term outcomes such as function, hospital length of stay and mortality rates. The CCI will be completed using information gathered from patients' hospital chart.with all patients.
All patients will be assigned a scientific pedometer on the day of randomization. The modus Health StepWatch™ is an activity monitor worn on the ankle via a velcro strap. It is a small, lightweight device that will count and record patients' steps throughout hospital stay, ending at hospital discharge. Research personnel will be responsible for fitting the StepWatch monitor to patients' ankle. The device is smaller than a deck of cards (7.5 x 5.0 x 2.0 cm) and weighs 38 grams.
Frailty and de-conditioning will be measured on Study Day 3. Frailty will be assessed using the Jamar Hand Dynamometer. Patients are instructed to squeeze the handle of the instrument with their maximum force for three seconds; the peak-hold (in kilograms) is recorded on the instrument. Three successive peak-hold measurements will be recorded. The device measures 10 x 20 x 33cm and weighs 1.3 kg. Deconditioning will be measured using the Timed Up and Go (TUG) test, patients will be asked to stand up from a chair, walk three metres, turn around, and walk back to the chair and sit.
After hospital discharge the RC will follow up with patients for 2 brief telephone interviews. On the third day after discharge, Patient Satisfaction surveys will be conducted by the RC to assess patient satisfaction with their hospital experience and with the WalkMORE program. On day 30 after randomization, the RC will contact patients to conduct a brief interview consisting of: a health status survey (EQ-5D), a functional status assessment (Barthel Index) and to collect data regarding clinical outcomes (ER visits, re-hospitalizations, and falls). Each telephone interview is expected to last approximately 10 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients receive no intervention |
| WalkMORE group | Active comparator | Behavioral: WalkMORE groupPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WalkMORE groupHospitalized Internal Medicine patients will walk with trained volunteers twice daily until hospital discharge. | Behavioural | WalkMORE group |
Primary outcome
Re-hospitalization
Time frame: 30 days after randomization
Number of patients re-admitted to hospital
Presentation to emergency department
Time frame: 30 days after randomization
Number of patients seen in the hospital emergency department
Prolonged index hospital admission
Time frame: 30 days after randomization
Number of patients with extended length of hospital admission
8 secondary outcomes
Length of stay for index hospital admission
Time frame: 30 days after randomization
Post-discharge Falls
Time frame: 30 days after randomization
Timed-Up-And-Go
Time frame: 30 days after randomization
Barthel Index
Time frame: 30 days after randomization
Frailty
Time frame: 30 days after randomization
Deconditioning
Time frame: 30 days after randomization
Increased number of steps
Time frame: 30 days after randomization
EQ-5D
Time frame: 30 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WalkMORE group in people with Frailty and Deconditioning, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-hospitalization (time frame: 30 days after randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.