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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
  • 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

    Recruiting

Other trials in Canada

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.

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 groups in NCT03337178
Study groupRoleWhat they receive
ControlNo interventionStandard of care
Blinded FitbitExperimentalBlinded Fitbit, no step goal, and no activity feedback
Receives: Behavioral: Blinded Fitbit
FitbitExperimentalFitbit 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.

  1. Self-Paced Walking Test

    Variability of the self-paced walking test

    Measured: Change in 3 months post-op from baseline

Secondary outcomes (8)
  1. 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

  2. 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

  3. Steps walked/day

    Comparison of Fitbit activity data of steps taken between groups

    Measured: Change in 3 months post-op from baseline

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted8 Nov 2017
  2. Study start1 Aug 2018
  3. Primary completion31 Aug 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

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)
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

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.

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