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

The London Spine Centre

Status: Unknown

Conditions: Lumbar Degenerative Spinal Stenosis

Treatments: Behavioral: Blinded Fitbit; Behavioral: Fitbit

Study type: Interventional

Funder types: Other

Identifiers

NCT03337178

ReDA359

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Control

No Intervention group

Description:

Standard of care

Blinded Fitbit

Experimental group

Description:

Blinded Fitbit, no step goal, and no activity feedback

Treatment:

Behavioral: Blinded Fitbit

Fitbit

Experimental group

Description:

Fitbit plus step goal and activity feedback

Treatment:

Behavioral: Fitbit