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

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: Unknown
• Conditions: Lumbar Degenerative Spinal Stenosis
• Intervention / Treatment: Behavioral: Blinded Fitbit; Behavioral: Fitbit

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6G 5L7
      • Recruiting
      • London Health Sciences Centre
      • Contact: Christopher S Bailey, MD; Phone Number: 55358 519-685-8500; Email: Chris.Bailey@lhsc.on.ca
      • Principal Investigator: Christopher S Bailey, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Self-Paced Walking Test	Variability of the self-paced walking test	Change in 3 months post-op from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Change in 3 months post-op from baseline
Steps walked/day	Comparison of Fitbit activity data of steps taken between groups	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	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	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.	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.	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.	Change in 3 months post-op from baseline

Collaborators and Investigators

• Sponsor: The London Spine Centre

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID 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