Additional Weekend PhysiotherapyNCT04565626
Impact of Additional Unsupervised Peddle Bike Physiotherapy on Acutely Hospitalized Medicine Inpatients
A study testing Additional weekend physiotherapy in people with Additional Weekend Physiotherapy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Additional Weekend Physiotherapy
- What is being tested?
- Additional weekend physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2021to Sep 2022
- 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
- Age greater than 18 years
- Cognitively safe for participation
- Anticipated to remain hospitalized ≥48 hours
- Inpatient, admitted to Internal Medicine Unit at University Hospital
- Able to understand and follow instruction in the English language
- Patient is receiving physiotherapy treatment from an LHSC inpatient physiotherapist
Who cannot join
- Contraindications to exercise safely (pre-existing illness or acute illness) identified by patient's medical team
- Patient is non-ambulatory at baseline
- Patient or SDM is not interested in participating in the study
- Patient is incapable of providing consent and no SDM is available
- Communication/ language barrier. Participants need to be able to communicate and follow verbal instructions in English. Information pamphlets and consent forms will be only in English language.
- Palliation or terminal illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Additional Unsupervised Peddle Bike Physiotherapy on Acutely Hospitalized Medicine Inpatients: a Feasibility Study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Additional Weekend Physiotherapy
- Being tested
- Additional weekend physiotherapy
- Keywords
- weekend, physiotherapy, deconditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional weekend physiotherapyOther
Patients randomized to intervention would receive a Medical Exercise Bike Pedal Exerciser Mini Peddler to allow for an additional 20 minutes a day of unsupervised physiotherapy both during the week and on weekends.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive additional exercise by independent use of a peddle bike on the weekends. This is in addition to their usual physiotherapy Receives: Other: Additional weekend physiotherapy |
| Control | No intervention | This arm will receive usual physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient adherence to additional weekend physiotherapy by unsupervised peddle bike
The investigators will assess the feasibility of a larger randomized control trial during which acutely hospitalized Internal Medicine patients participate in unsupervised pedal bike exercise for additional physiotherapy in addition to usual weekday hour physiotherapy. The investigators will collect data on adherence to protocol through the use of patient log to track patient activity. This patient log will track minutes of use per week of the peddle bike.
Measured: 1 year
Recruitment
Ease of recruitment through monitoring of recruitment rate, refusal rate, and retention rate.
Measured: 1 year
Emergent Adverse Events
Adverse events will be monitored through measuring falls, new fractures, and reported musculoskeletal pain requiring treatment.
Measured: 1 year
Patient Perceptions
Patient perception of the peddle bike protocol will measured through a questionnaire at post discharge follow-up.
Measured: 1 year
Completeness
Completeness measured as number of missing outcome measures
Measured: 1 year
Secondary outcomes (7)
Deconditioning as measured by the Timed up and go score
This score will be measured on day 3 and 6 of admission. This score is measured in seconds with a minimum being 0 seconds and no upper limit. A lower score indicates a better outcome.
Measured: 1 year
Discharge destination
Identify discharge destination (home, low level residential care, high level residential care, and acute hospital transfer)
Measured: 1 year
Health related quality of life measured by the European Quality of Life, 5 dimensions (EQ-5D-5 L) instrument
The investigators will measure health-related quality of life at 3 days post discharge from hospital using the European Quality of Life, 5 dimensions score. A minimum score is 0 and a maximum is 100. A higher score indicates a better outcome.
Measured: 1 year
Length of stay
Decrease length of stay of index hospitalization, measured via admission and discharge dates
Measured: 1 year
Readmission
Measure rate of readmission 30 days post discharge for falls measured via follow up telephone call and emergency room documentation
Measured: 30 days
Deconditioning as measured by the Discharge Barthal Index for Activities of Daily Living score
This score will be measured on admission and 30 days after discharge from hospital. The minimum score is 0 and the maximum is 100. A higher score indicates a better outcome.
Measured: 1 year
Deconditioning as measured by the Short Physical Performance Battery score
This score will be measured on the day of admission, and on days 3 and 6 of admission. The minimum score is 0 and the maximum score is 12. A higher score indicates a better outcome.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study startNov 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Additional Weekend PhysiotherapyStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
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
- NCT04565626
- Sponsor's protocol ID
- 116450
- Status last verified
- Mar 2024
- First submitted
- 2 Sep 2020
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will only be shared within the research team consisting of Dr. Melanie Le May, Dr. Erin Spicer, Dr. Marko Mrkobrada, Stephanie Handsor, and Karen Broadhurst
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Additional Unsupervised Peddle Bike Physiotherapy on Acutely Hospitalized Medicine Inpatients: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04565626
- Acronym / sponsor ID
- 116450
- Conditions
- Additional Weekend Physiotherapy
- Keywords
- weekend, physiotherapy, deconditioning
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 25 Sep 2020 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Additional weekend physiotherapyParticipants will receive additional exercise by independent use of a peddle bike on the weekends. This is in addition to their usual physiotherapy |
| Control | No intervention | –This arm will receive usual physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than 18 years
- Cognitively safe for participation
- Anticipated to remain hospitalized ≥48 hours
- Inpatient, admitted to Internal Medicine Unit at University Hospital
- Able to understand and follow instruction in the English language
Key exclusion criteria (6 listed)
- Contraindications to exercise safely (pre-existing illness or acute illness) identified by patient's medical team
- Patient is non-ambulatory at baseline
- Patient or SDM is not interested in participating in the study
- Patient is incapable of providing consent and no SDM is available
- Communication/ language barrier. Participants need to be able to communicate and follow verbal instructions in English. Information pamphlets and consent forms will be only in English language.
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 |
|---|---|---|
| Additional weekend physiotherapyPatients randomized to intervention would receive a Medical Exercise Bike Pedal Exerciser Mini Peddler to allow for an additional 20 minutes a day of unsupervised physiotherapy both during the week and on weekends. | Other | Intervention |
Primary outcome
Patient adherence to additional weekend physiotherapy by unsupervised peddle bike
Time frame: 1 year
The investigators will assess the feasibility of a larger randomized control trial during which acutely hospitalized Internal Medicine patients participate in unsupervised pedal bike exercise for additional physiotherapy in addition to usual weekday hour physiotherapy. The investigators will collect data on adherence to protocol through the use of patient log to track patient activity. This patient log will track minutes of use per week of the peddle bike.
Recruitment
Time frame: 1 year
Ease of recruitment through monitoring of recruitment rate, refusal rate, and retention rate.
Emergent Adverse Events
Time frame: 1 year
Adverse events will be monitored through measuring falls, new fractures, and reported musculoskeletal pain requiring treatment.
Patient Perceptions
Time frame: 1 year
Patient perception of the peddle bike protocol will measured through a questionnaire at post discharge follow-up.
Completeness
Time frame: 1 year
Completeness measured as number of missing outcome measures
7 secondary outcomes
Deconditioning as measured by the Timed up and go score
Time frame: 1 year
Discharge destination
Time frame: 1 year
Health related quality of life measured by the European Quality of Life, 5 dimensions (EQ-5D-5 L) instrument
Time frame: 1 year
Length of stay
Time frame: 1 year
Readmission
Time frame: 30 days
Deconditioning as measured by the Discharge Barthal Index for Activities of Daily Living score
Time frame: 1 year
Deconditioning as measured by the Short Physical Performance Battery score
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No. The IPD will only be shared within the research team consisting of Dr. Melanie Le May, Dr. Erin Spicer, Dr. Marko Mrkobrada, Stephanie Handsor, and Karen Broadhurst
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 Additional weekend physiotherapy in people with Additional Weekend Physiotherapy, 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 6 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: withdrawn, as of the sponsor's last update on 5 Mar 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Patient adherence to additional weekend physiotherapy by unsupervised peddle bike (time frame: 1 year). The study lists 5 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 5 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.