Fitbit Pilot Study in Post-operative Lumbar Degenerative Spinal Stenosis Patients

August 20, 2020 updated by: The London Spine Centre

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6G 5L7
        • Recruiting
        • London Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Christopher S Bailey, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Standard of care
Experimental: Blinded Fitbit
Blinded Fitbit, no step goal, and no activity feedback
Behavioral: Blinded Fitbit
Fitbit is worn for 3 months post-operatively with no activity feedback or step goals
Experimental: Fitbit
Fitbit plus step goal and activity feedback
Behavioral: Fitbit
Fitbit is worn for 3 months post-operatively with feedback and step goals

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-Paced Walking Test
Time Frame: Change in 3 months post-op from baseline
Variability of the self-paced walking test
Change in 3 months post-op from baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Recruitment
Time Frame: Number consented by 17 months
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).
Number consented by 17 months
Self-paced walking test
Time Frame: Change in 3 months post-op from baseline
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.
Change in 3 months post-op from baseline
Steps walked/day
Time Frame: Change in 3 months post-op from baseline
Comparison of Fitbit activity data of steps taken between groups
Change in 3 months post-op from baseline
Leg Pain
Time Frame: Change in 3 months post-op from baseline
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
Change in 3 months post-op from baseline
Back Pain
Time Frame: Change in 3 months post-op from baseline
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
Change in 3 months post-op from baseline
General Health
Time Frame: Change in 3 months post-op from baseline
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.
Change in 3 months post-op from baseline
Functional Ability
Time Frame: Change in 3 months post-op from baseline
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.
Change in 3 months post-op from baseline
Functional Ability
Time Frame: Change in 3 months post-op from baseline
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.
Change in 3 months post-op from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The London Spine Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ReDA359

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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