Lumbar Degenerative Spinal StenosisNCT03337178
Fitbit Pilot Study in Post-operative Lumbar Degenerative Spinal Stenosis Patients
A study testing Blinded Fitbit and Fitbit in people with Lumbar Degenerative Spinal Stenosis, run by The London Spine Centre at 1 site in Canada.
Trial summary
Spinal stenosis is a common orthopedic spine condition that limits individuals ability to walk and stand because of nerve compression. Surgical treatment can alleviate leg pain and improve function such as increasing physical activity. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Lumbar Degenerative Spinal Stenosis
- What is being tested?
- Blinded Fitbit and Fitbit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2018to 31 Dec 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years of age and older
- diagnosed with neurogenic claudication or radiculopathy secondary to central or lateral recess stenosis between L3-L5 confirmed by CT or MRI
- consent for surgical treatment
Who cannot join
- traumatic stenosis from a pathologic fracture
- inflammatory spine disease
- peripheral arterial disease
- hip or knee arthritis or pulmonary or circulatory diseases for which exercise is contraindicated
- severe or progressive neurologic deficit effecting ambulatory ability
- cancer
- no access to a computer or mobile device
- inability to complete the questionnaires or provide follow-up (i.e. lack of permanent address, substance abuse, interfering psychiatric illness).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6G 5L7
Christopher S Bailey, MD, 519-685-8500 ext. 55358, Chris.Bailey@lhsc.on.ca
Christopher S Bailey, MD
About this study
Official title: Fitbit Pilot Study to Increase Physical Activity and Overall Health in Post-operative Lumbar Degenerative Spinal Stenosis Patients
Spinal stenosis is a common orthopedic spine condition that limits individuals ability to walk and stand because of nerve compression. Surgical treatment can alleviate leg pain and improve function such as increasing physical activity. This study will use Fitbit technology to monitor patient's post-operative physical activity. It will evaluate the efficacy of a Fitbit incentive based walking program on improving post-operative physical activity and rehabilitation.
- Conditions
- Lumbar Degenerative Spinal Stenosis
- Being tested
- Blinded Fitbit, Fitbit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinded FitbitBehavioural
Fitbit is worn for 3 months post-operatively with no activity feedback or step goals
FitbitBehavioural
Fitbit is worn for 3 months post-operatively with feedback and step goals
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard of care |
| Blinded Fitbit | Experimental | Blinded Fitbit, no step goal, and no activity feedback Receives: Behavioral: Blinded Fitbit |
| Fitbit | Experimental | Fitbit plus step goal and activity feedback Receives: Behavioral: Fitbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Paced Walking Test
Variability of the self-paced walking test
Measured: Change in 3 months post-op from baseline
Secondary outcomes (8)
Patient Recruitment
Participants will be included if they are 60 years of age and older, diagnosed with neurogenic claudication or radiculopathy secondary to central or lateral recess stenosis between L3-L5 confirmed by CT or MRI, and consent for surgical treatment. Include patients with Grade 1 spondylolithesis. Patients will be excluded if the stenosis was not degenerative (i.e. traumatic stenosis from a pathologic fracture), they had inflammatory spine disease, they had peripheral arterial disease, or pulmonary or circulatory diseases for which exercise is contraindicated, osteoarthritis in the lower extremities, severe or progressive neurologic deficit requiring urgent surgery, cancer, previous lumbar surgery, they have no access to a computer or mobile device, an inability to complete the questionnaires or provide follow-up (i.e. lack of permanent address, substance abuse, interfering psychiatric illness).
Measured: Number consented by 17 months
Self-paced walking test
Self-paced walk test (SPWT) is a validated measure of walking capacity in lumbar degenerative spinal stenosis. The individual walks comfortably at his/her own pace until he/she must rest due to symptoms of back or leg pain. The total time and distance walked is recorded, time/distance to onset of symptoms, and nature and location of symptoms (pain numbness/tingling, weakness or fatigue), average walking speed, and reason for termination (symptoms of LSS, fatigue, shortness of breath, pain, other comorbidities). Patients are not permitted to use an assistive device. The test is either self-terminated (complete stop of 3 seconds or more) due to symptoms or at 30 minutes whichever occurs first. Participants are asked to indicate when they first experience symptoms.
Measured: Change in 3 months post-op from baseline
Steps walked/day
Comparison of Fitbit activity data of steps taken between groups
Measured: Change in 3 months post-op from baseline
Leg Pain
Numeric Rating Score for Leg Pain. The (NRS) for leg pain numeric rating scale ranges from 0 to 10, with lower scores indicating less severe symptoms
Measured: Change in 3 months post-op from baseline
Back Pain
Numeric Rating Score for Back Pain. The (NRS) for back pain numeric rating scale ranges from 0 to 10, with lower scores indicating less severe symptoms
Measured: Change in 3 months post-op from baseline
General Health
General health assessed by SF12. The SF12 is a generic, multidimensional self-report health questionnaire and is validated when applied to the spine patient. Questions are categorized into scales for general health, physical functioning, social functioning, role limitation-physical, role limitation-emotional, mental health, energy/fatigue, pain, comparative health. These are summarized into the SF12-physical component summary score (PCS) and mental component summary score (MCS). Scores range from 0 to 100. Higher scores imply better functioning.
Measured: Change in 3 months post-op from baseline
Functional Ability
Functional ability assessed by Oswestry Disability Index. Oswestry Disability Index (ODI) is a validated questionnaire in lumbar degenerative spinal stenosis patients that assesses back pain-related disability. A higher score denotes worsening disability.
Measured: Change in 3 months post-op from baseline
Functional Ability
Functional ability assessed by Swiss Spinal Stenosis Questionnaire. Swiss spinal stenosis questionnaire (SSS) is a validated 12-item condition-specific instrument for lumbar degenerative spinal stenosis that is known to be internally consistent and reliable and responsive to clinical change. It is a self-reported measure of pain and physical function. Higher scores represent worse physical function. The score for physical function was calculated as the un-weighted mean of the five items of the scale. The resulting possible scores of 1-4 represent mild to severe limitation in physical function. The Symptom Severity Scale will be used by averaging the scores the seven items. Responses range from 1-7 indicating mild to severe pain.
Measured: Change in 3 months post-op from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Aug 2018
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Degenerative Spinal StenosisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The London Spine Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337178
- Sponsor's protocol ID
- ReDA359
- Status last verified
- Aug 2020
- First submitted
- 11 Jul 2017
- Last updated
- 21 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fitbit Pilot Study to Increase Physical Activity and Overall Health in Post-operative Lumbar Degenerative Spinal Stenosis Patients
- ClinicalTrials.gov ID
- NCT03337178
- Acronym / sponsor ID
- ReDA359
- Conditions
- Lumbar Degenerative Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The London Spine CentreUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 8 Nov 2017 (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.
Spinal stenosis is a common orthopedic spine condition that limits individuals ability to walk and stand because of nerve compression. Surgical treatment can alleviate leg pain and improve function such as increasing physical activity. This study will use Fitbit technology to monitor patient's post-operative physical activity. It will evaluate the efficacy of a Fitbit incentive based walking program on improving post-operative physical activity and rehabilitation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care |
| Blinded Fitbit | Experimental | Behavioral: Blinded FitbitBlinded Fitbit, no step goal, and no activity feedback |
| Fitbit | Experimental | Behavioral: FitbitFitbit plus step goal and activity feedback |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 years of age and older
- diagnosed with neurogenic claudication or radiculopathy secondary to central or lateral recess stenosis between L3-L5 confirmed by CT or MRI
- consent for surgical treatment
Key exclusion criteria (8 listed)
- traumatic stenosis from a pathologic fracture
- inflammatory spine disease
- peripheral arterial disease
- hip or knee arthritis or pulmonary or circulatory diseases for which exercise is contraindicated
- severe or progressive neurologic deficit effecting ambulatory ability
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 |
|---|---|---|
| Blinded FitbitFitbit is worn for 3 months post-operatively with no activity feedback or step goals | Behavioural | Blinded Fitbit |
| FitbitFitbit is worn for 3 months post-operatively with feedback and step goals | Behavioural | Fitbit |
Primary outcome
Self-Paced Walking Test
Time frame: Change in 3 months post-op from baseline
Variability of the self-paced walking test
8 secondary outcomes
Patient Recruitment
Time frame: Number consented by 17 months
Self-paced walking test
Time frame: Change in 3 months post-op from baseline
Steps walked/day
Time frame: Change in 3 months post-op from baseline
Leg Pain
Time frame: Change in 3 months post-op from baseline
Back Pain
Time frame: Change in 3 months post-op from baseline
General Health
Time frame: Change in 3 months post-op from baseline
Functional Ability
Time frame: Change in 3 months post-op from baseline
Functional Ability
Time frame: Change in 3 months post-op from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blinded Fitbit and Fitbit in people with Lumbar Degenerative Spinal Stenosis, run by The London Spine Centre 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 8 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: status not confirmed, as of the sponsor's last update on 21 Aug 2020. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Paced Walking Test (time frame: Change in 3 months post-op from baseline). 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 21 Aug 2020.