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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2017
CompletedFirst Posted
Study publicly available on registry
November 8, 2017
CompletedStudy Start
First participant enrolled
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedAugust 21, 2020
August 1, 2020
4.1 years
July 11, 2017
August 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Self-Paced Walking Test
Variability of the self-paced walking test
Change in 3 months post-op from baseline
Secondary Outcomes (8)
Patient Recruitment
Number consented by 17 months
Self-paced walking test
Change in 3 months post-op from baseline
Steps walked/day
Change in 3 months post-op from baseline
Leg Pain
Change in 3 months post-op from baseline
Back Pain
Change in 3 months post-op from baseline
- +3 more secondary outcomes
Study Arms (3)
Control
NO INTERVENTIONStandard of care
Blinded Fitbit
EXPERIMENTALBlinded Fitbit, no step goal, and no activity feedback
Fitbit
EXPERIMENTALFitbit plus step goal and activity feedback
Interventions
Fitbit is worn for 3 months post-operatively with no activity feedback or step goals
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Health Sciences Centre
London, Ontario, N6G 5L7, Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2017
First Posted
November 8, 2017
Study Start
August 1, 2018
Primary Completion
August 31, 2022
Study Completion
December 31, 2022
Last Updated
August 21, 2020
Record last verified: 2020-08