Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04565626 |
| Other study ID # |
116450 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2021 |
| Est. completion date |
September 2022 |
Study information
| Verified date |
March 2024 |
| Source |
Lawson Health Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
During an acute hospitalization, deconditioning from decreased mobility can lead to
functional decline. Muscle weakness can lead to frailty, which is linked to falls,
immobility, rehospitalisation, institutionalization, and mortality. Many elderly do not
regain muscle mass similar to prior to hospitalization and are discharged with worse than
baseline function. Early mobilization and physical rehabilitation can improve or prevent loss
of function in hospitalized patients. Weekend physiotherapy ensures gains made in mobility
during the week are maintained, however, the benefit of additional weekend physiotherapy on
acutely hospitalized Internal Medicine adult patients remains unclear.
Given this uncertainty, the investigators propose a randomized controlled trial pilot study
to examine the outcomes of additional unsupervised physiotherapy. Patients randomized to
intervention would receive a Medical Exercise Bike Pedal Exerciser to allow for an additional
20 minutes a day of un-supervised physiotherapy both during the week and on weekends.
Deconditioning will be measured for all study participants while hospitalized. After hospital
discharge, patients will be telephoned on post-discharge day 3, to assess patient
satisfaction and quality of life, and post-discharge day 30 to collect data regarding
clinical outcomes (ER visits, re-hospitalizations, and falls).
The investigators hypothesize that it is feasible and safe to have additional unsupervised
physiotherapy in the elderly population hospitalized for an acute illness on a medical ward
and that this will result in improvement in function at discharge due to decreased hospital
acquired deconditioning with improved mobility, quality of life and subsequent decreased
readmission for falls.
Description:
After obtaining written informed consent from eligible patients, study staff will randomize
patients, collect demographics and hospital admission details from patients' hospital charts,
and complete the Charlson Comorbidity Index (CCI) for all patients. The CCI will be completed
using information gathered from patients' hospital chart. They will then perform the Barthel
Index (BI) and Short Physical Performance Battery (SPPB) to determine a baseline physical
ability of the patient.
The BI measures the extent to which patients can function independently and has mobility in
their activities of daily living (ADL). The SPPB is a group of measures that combines the
results of the gait speed, chair stand and balance tests (Guralnik et al., 2000). It has been
used as a predictive tool for possible disability and can aid in the monitoring of function
in older people. 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 target sample size will be 75. This will be divided between intervention and no
intervention (control). Patients will be allocated to either intervention with peddle bike
for additional unsupervised exercise or current standard of care as control group.
Randomization will be done using RedCap.
Patients randomized to intervention would receive a Medical Exercise Bike Pedal Exerciser
Mini Peddler to allow for an additional 20 minutes a day of un-supervised physiotherapy both
during the week and on weekends. Patients would be provided with an information pamphlet on
the benefits of staying active during a hospitalization. Each bike will have an LCD monitor
to keep track of patient use. They will receive a short teaching session on how to properly
use the bike and record their use in their log. Exercise time (in minutes), distance (in
kilometers) and calories will be recorded off the bike LCD monitor after each session and
recorded in the patient's daily exercise log. They will also be assisted with follow-up
meetings with the research therapist, and the involvement of the family (if available) from
the outset, which has previously been shown to improve compliance. Patients randomized to the
Bike Pedal Exerciser intervention will be assessed daily by the study staff & the medical
team to ensure patients remain safe for use of the bike.
All participants (both intervention and control) will receive a Stepwatch to monitor their
activity. This will be worn at all times in the study with the purpose to measure overall
activity between the two groups. The investigators will manually remove the activity of the
peddle bike from their overall activity in the intervention group to give a baseline activity
rate. This will be to monitor for baseline activity in both groups and ensure that the
intervention participants are not substituting the peddle bike for usual daily activity.
Deconditioning will be measured for all study participants on study day 3 and study day 6 (or
the day of discharge) using the Timed Up and Go (TUG) test and Short Physical Performance
Battery. For the TUG, 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 research staff will follow up with all patients for 2 brief
telephone interviews. On day 3 after discharge, Patient Satisfaction surveys* will be
conducted by to assess patient satisfaction with their experience with their hospital stay &
Peddle Bike program. They will also conduct the European Quality of Life, 5 dimensions*
(EQ-5D-5 L) instrument to assess quality of life. At 30 days after randomization, the
research staff will contact patients to conduct a brief interview consisting of: 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.
Peddle bikes will remain in a patient's room for the duration of their hospitalization and/or
enrollment and will be cleaned between patient use to decrease risk of contamination.
Patients are assessed daily by their medical team as part of their standard care when
hospitalized. If the team flags the patient as being incapable of using the peddle bike
safely (i.e. patient is delirious or aggressive), the patient will be removed from the study.
