Fitbit Pilot Study in Post-operative Lumbar Degenerative Spinal Stenosis Patients
Primary Purpose
Lumbar Degenerative Spinal Stenosis
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Blinded Fitbit
Fitbit
Sponsored by
About this trial
This is an interventional other trial for Lumbar Degenerative Spinal Stenosis
Eligibility Criteria
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).
Sites / Locations
- London Health Sciences CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control
Blinded Fitbit
Fitbit
Arm Description
Standard of care
Blinded Fitbit, no step goal, and no activity feedback
Fitbit plus step goal and activity feedback
Outcomes
Primary Outcome Measures
Self-Paced Walking Test
Variability of the self-paced walking test
Secondary Outcome Measures
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).
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.
Steps walked/day
Comparison of Fitbit activity data of steps taken between groups
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
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
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03337178
Brief Title
Fitbit Pilot Study in Post-operative Lumbar Degenerative Spinal Stenosis Patients
Official Title
Fitbit Pilot Study to Increase Physical Activity and Overall Health in Post-operative Lumbar Degenerative Spinal Stenosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The London Spine Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Degenerative Spinal Stenosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care
Arm Title
Blinded Fitbit
Arm Type
Experimental
Arm Description
Blinded Fitbit, no step goal, and no activity feedback
Arm Title
Fitbit
Arm Type
Experimental
Arm Description
Fitbit plus step goal and activity feedback
Intervention Type
Behavioral
Intervention Name(s)
Blinded Fitbit
Intervention Description
Fitbit is worn for 3 months post-operatively with no activity feedback or step goals
Intervention Type
Behavioral
Intervention Name(s)
Fitbit
Intervention Description
Fitbit is worn for 3 months post-operatively with feedback and step goals
Primary Outcome Measure Information:
Title
Self-Paced Walking Test
Description
Variability of the self-paced walking test
Time Frame
Change in 3 months post-op from baseline
Secondary Outcome Measure Information:
Title
Patient Recruitment
Description
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).
Time Frame
Number consented by 17 months
Title
Self-paced walking test
Description
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.
Time Frame
Change in 3 months post-op from baseline
Title
Steps walked/day
Description
Comparison of Fitbit activity data of steps taken between groups
Time Frame
Change in 3 months post-op from baseline
Title
Leg Pain
Description
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
Time Frame
Change in 3 months post-op from baseline
Title
Back Pain
Description
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
Time Frame
Change in 3 months post-op from baseline
Title
General Health
Description
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.
Time Frame
Change in 3 months post-op from baseline
Title
Functional Ability
Description
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.
Time Frame
Change in 3 months post-op from baseline
Title
Functional Ability
Description
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.
Time Frame
Change in 3 months post-op from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 5L7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher S Bailey, MD
Phone
519-685-8500
Ext
55358
Email
Chris.Bailey@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Christopher S Bailey, MD
12. IPD Sharing Statement
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Fitbit Pilot Study in Post-operative Lumbar Degenerative Spinal Stenosis Patients
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