Hip FracturesREST-UPNCT03776526
Researching the Effects of Sleep on STep Count dUring the Postoperative Period
An observational study of Hip Fractures and Sleep, run by Christopher Patterson at 1 site in Canada.
Trial summary
Patients over the age of 65 who are admitted to the Juravinski Hospital for treatment of hip fractures will be invited to take part in the study. An activity monitor (a Fitbit® Alta HR) will be attached to the participant post-operatively, to record quality of sleep and amount of activity for the duration of hospital… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Sleep, Postoperative Complications
- What is being tested?
- Fitbit® Alta HR Sleep monitoring
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2018to 30 Jun 2019
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients admitted to orthopedic ward after surgery for repair of hip fracture. Hamilton Health Sciences Corporation, Juravinski Hospital Site.
Who may be able to join
- Patients recovering from surgery for hip fracture
- 65 years of age or older
- Able to provide informed consent or has a substitute decision maker able to provide consent
Who cannot join
- Bed or wheelchair bound prior to fracture
- Physical barrier to placement of device (wrist restraints, cast for wrist fracture)
- Non-operative hip fractures
- Pathologic hip fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Researching the Effects of Sleep on Step Count During the Postoperative Period Following Surgery for Hip Fracture
Patients over the age of 65 who are admitted to the Juravinski Hospital for treatment of hip fractures will be invited to take part in the study. An activity monitor (a Fitbit® Alta HR) will be attached to the participant post-operatively, to record quality of sleep and amount of activity for the duration of hospital stay. The time spent in hospital and whether complications or confusion develops will also be recorded. The aim is to determine whether poor sleep affects recovery after hip fracture surgery.
Read the detailed description
The purpose of this study is to examine the influence of sleep duration and quality on post-operative mobility in older adults admitted to hospital with a hip fracture. The hypothesis is that poor sleep will independently predict low post-operative mobility (measured by number of steps). Recent developments in activity monitor technology allow for the collection of reliable assessments of movement and sleep rhythm during surgical recovery.
The Fitbit® Alta HR activity monitor will be used for this study. When the participant is awake and alert after surgery and informed consent has been obtained, a study team member will fasten the Fitbit® device on the wrist of the participants' non-dominant hand. Investigators will monitor sleep quality and daily steps taken for the duration of hospitalization, with the option to discontinue if clinically required or requested by the patient or provider. At the time of discharge, the wearable biosensor will be reset and the information will be erased from its memory. The wearable biosensors will be cleaned with disinfectant used for durable medical equipment.
The study population will include patients aged 65+ admitted with hip fracture to the orthopedic ward (E2) at the Juravinski Hospital. Descriptive data on patients admitted with hip fracture will be collected including age, gender, Charlson comorbidity index, diagnosis of dementia, pre-hospital living accommodation, mobility aids, level of pre-admission mobility using the functional independence measure (FIM), and number of beds per room. Timing of surgery (within 24 hours, 48 hours, or more than 48 hours) after admission, highest reported daily pain score and foley catheter use will also be collected from the medical record. The use of sleep medications will be tracked each night during the study period. The physiotherapy notes will be screened for information on total distance ambulated in meters and in-hospital mobility progression. Post-operative complications such as Stroke, Cardiac event, Pneumonia, Venous thromboembolism, GI tract bleed, Urinary tract infections, Postoperative anemia, Acute Kidney Injury, and Pressure sores will be tracked from the medical record. Investigators will also contact participants by phone after 30 days have elapsed since discharge to inquire about mortality, FIM score and location of disposition.
The primary outcome is the total number of steps taken by participants during each 24-hour period after surgery for hip fracture. Mean daily steps will be calculated based on the number of days the activity monitor was worn. Secondary outcomes will be delirium prevalence, hospital length of stay, post-operative complications, 30-day post-discharge mortality, mobility status (FIM - locomotion subscale score), and location of disposition. The primary behavioural exposure is monitoring of sleep duration (measured by total sleep time in minutes) and quality (number of awakenings per night). Daytime naps will also be recorded.
One of the key strengths of this study is that both the primary outcome and the key exposure are measured using a single device, which improves the reliability and efficiency of data collection
- Conditions
- Hip Fractures, Sleep, Postoperative Complications, Delirium
- Being tested
- Fitbit® Alta HR Sleep monitoring
- Keywords
- Hip fractures
- Medical subject headings
- Hip Fractures, Postoperative Complications, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit® Alta HR Sleep monitoringBehavioural
Patients will be fitted with a Fitbit® Alta HR after surgery, which will monitor sleep quality (sleep duration and number of awakenings) for the duration of hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative Hip fracture patients | The target population will include patients aged 65 years or older admitted with hip fracture to the orthopedic ward at the Juravinski Hospital, a site of Hamilton Health Sciences Corporation in Ontario, Canada. Receives: Behavioral: Fitbit® Alta HR Sleep monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps per 24-hour day taken by patients during hospital admission after hip fracture repair.
Mean daily step count as measured by Fitbit®
Measured: Through study completion, on average 1 week
Secondary outcomes (7)
Delirium rate (incidence)
Delirium assessed by confusion assessment method (CAM)
Measured: Through study completion, on average 1 week
Length of stay in hospital
Days from admission until discharge from hospital
Measured: Through study completion, on average 1 week
Post-operative complications
Stroke, Cardiac event, Pneumonia, Venous thromboembolism, GI tract bleed, Urinary tract infections, Postoperative anemia, Acute Kidney Injury, and Pressure sores
Measured: Through study completion, on average 1 week
30-day post-discharge mortality
Death within 30 days
Measured: 30 days post discharge
30 day mobility status
Functional Independence Measure - locomotion subscale score
Measured: 30 days post discharge
Location of disposition
community independent, community with home care, community with family support, inpatient rehabilitation, convalescent care, long term care, acute care hospital
Measured: Through study completion, on average 1 week
Location of disposition at 30 days
community independent, community with home care, community with family support, inpatient rehabilitation, convalescent care, long term care, acute care hospital
Measured: 30 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start1 Mar 2018
- Primary completion1 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Patterson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher Patterson, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776526
- Sponsor's protocol ID
- REST-UP
- Acronym
- REST-UP
- Status last verified
- Jun 2021
- First submitted
- 26 Jul 2018
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Researching the Effects of Sleep on Step Count During the Postoperative Period Following Surgery for Hip Fracture
- ClinicalTrials.gov ID
- NCT03776526
- Acronym / sponsor ID
- REST-UP / REST-UP
- Conditions
- Hip Fractures, Sleep, Postoperative Complications, Delirium
- Keywords
- Hip fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Christopher PattersonUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 14 Dec 2018 (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 over the age of 65 who are admitted to the Juravinski Hospital for treatment of hip fractures will be invited to take part in the study. An activity monitor (a Fitbit® Alta HR) will be attached to the participant post-operatively, to record quality of sleep and amount of activity for the duration of hospital stay. The time spent in hospital and whether complications or confusion develops will also be recorded. The aim is to determine whether poor sleep affects recovery after hip fracture surgery.
Detailed description
The purpose of this study is to examine the influence of sleep duration and quality on post-operative mobility in older adults admitted to hospital with a hip fracture. The hypothesis is that poor sleep will independently predict low post-operative mobility (measured by number of steps). Recent developments in activity monitor technology allow for the collection of reliable assessments of movement and sleep rhythm during surgical recovery.
The Fitbit® Alta HR activity monitor will be used for this study. When the participant is awake and alert after surgery and informed consent has been obtained, a study team member will fasten the Fitbit® device on the wrist of the participants' non-dominant hand. Investigators will monitor sleep quality and daily steps taken for the duration of hospitalization, with the option to discontinue if clinically required or requested by the patient or provider. At the time of discharge, the wearable biosensor will be reset and the information will be erased from its memory. The wearable biosensors will be cleaned with disinfectant used for durable medical equipment.
The study population will include patients aged 65+ admitted with hip fracture to the orthopedic ward (E2) at the Juravinski Hospital. Descriptive data on patients admitted with hip fracture will be collected including age, gender, Charlson comorbidity index, diagnosis of dementia, pre-hospital living accommodation, mobility aids, level of pre-admission mobility using the functional independence measure (FIM), and number of beds per room. Timing of surgery (within 24 hours, 48 hours, or more than 48 hours) after admission, highest reported daily pain score and foley catheter use will also be collected from the medical record. The use of sleep medications will be tracked each night during the study period. The physiotherapy notes will be screened for information on total distance ambulated in meters and in-hospital mobility progression. Post-operative complications such as Stroke, Cardiac event, Pneumonia, Venous thromboembolism, GI tract bleed, Urinary tract infections, Postoperative anemia, Acute Kidney Injury, and Pressure sores will be tracked from the medical record. Investigators will also contact participants by phone after 30 days have elapsed since discharge to inquire about mortality, FIM score and location of disposition.
The primary outcome is the total number of steps taken by participants during each 24-hour period after surgery for hip fracture. Mean daily steps will be calculated based on the number of days the activity monitor was worn. Secondary outcomes will be delirium prevalence, hospital length of stay, post-operative complications, 30-day post-discharge mortality, mobility status (FIM - locomotion subscale score), and location of disposition. The primary behavioural exposure is monitoring of sleep duration (measured by total sleep time in minutes) and quality (number of awakenings per night). Daytime naps will also be recorded.
One of the key strengths of this study is that both the primary outcome and the key exposure are measured using a single device, which improves the reliability and efficiency of data collection
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative Hip fracture patients | – | Behavioral: Fitbit® Alta HR Sleep monitoringThe target population will include patients aged 65 years or older admitted with hip fracture to the orthopedic ward at the Juravinski Hospital, a site of Hamilton Health Sciences Corporation in Ontario, Canada. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients admitted to orthopedic ward after surgery for repair of hip fracture. Hamilton Health Sciences Corporation, Juravinski Hospital Site.
Key inclusion criteria (3 listed)
- Patients recovering from surgery for hip fracture
- 65 years of age or older
- Able to provide informed consent or has a substitute decision maker able to provide consent
Key exclusion criteria (4 listed)
- Bed or wheelchair bound prior to fracture
- Physical barrier to placement of device (wrist restraints, cast for wrist fracture)
- Non-operative hip fractures
- Pathologic hip fracture
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 |
|---|---|---|
| Fitbit® Alta HR Sleep monitoringPatients will be fitted with a Fitbit® Alta HR after surgery, which will monitor sleep quality (sleep duration and number of awakenings) for the duration of hospitalization. | Behavioural | Postoperative Hip fracture patients |
Primary outcome
Number of steps per 24-hour day taken by patients during hospital admission after hip fracture repair.
Time frame: Through study completion, on average 1 week
Mean daily step count as measured by Fitbit®
7 secondary outcomes
Delirium rate (incidence)
Time frame: Through study completion, on average 1 week
Length of stay in hospital
Time frame: Through study completion, on average 1 week
Post-operative complications
Time frame: Through study completion, on average 1 week
30-day post-discharge mortality
Time frame: 30 days post discharge
30 day mobility status
Time frame: 30 days post discharge
Location of disposition
Time frame: Through study completion, on average 1 week
Location of disposition at 30 days
Time frame: 30 days post discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Hip Fractures
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
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?
An observational study of Hip Fractures and Sleep, run by Christopher Patterson 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 8 Jun 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of steps per 24-hour day taken by patients during hospital admission after hip fracture repair. (time frame: Through study completion, on average 1 week). 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 8 Jun 2021.