Increasing Long-Term Physical Activity After Lumbar Spine Surgery

Study Overview
=================
Brief Summary
-----------------
After recuperating from low back surgery patients often perpetuate a sedentary lifestyle because they are concerned about injury and recurrent pain. The objective of this study is to test the feasibility of a program to increase lifestyle walking starting several months after low back surgery.

Detailed Description
-----------------
The primary objective of this RCT is to compare energy expenditure from walking between an experimental group that receives a multi-component intervention based on the Health Belief Model of Behavior Change versus a control group. Patients who had surgery for a degenerative condition will be randomized postop when their surgeons deem them orthopedically stable to increase walking (at about 3 months).

Official Title
-----------------
Increasing Long-Term Physical Activity After Lumbar Spine Surgery

Conditions
-----------------
Lumbar Spine Degenerative Changes

Intervention / Treatment
-----------------
* Behavioral: Education/Self-efficacy
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be eligible if they had lumbar surgery for a degenerative condition and their surgeon deems it safe for them to walk more. Exclusion Criteria: Patients will be excluded if they had any new cardiopulmonary symptoms since surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Education/Self-efficacy<br>Booklet about physical activity, movement monitoring device, encouragement | Behavioral: Education/Self-efficacy<br>* The education/self-efficacy group will 1) receive information about benefits of physical activity and national activity guidelines, 2) receive instruction on how to increase lifestyle walking, 3) use movement monitoring devices, 4) make a walking contract and 5) receive interval contract-directed encouragement from study personnel.<br>|
| Active Comparator: Education<br>Booklet about physical activity | Behavioral: Education<br>* The education group will receive information about safe physical activity.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly energy expenditure in kilocalories per week as measured by the Paffenbarger Physical Activity and Exercise Index | Change in enrollment to 16-week Paffenbarger Physical Activity and Exercise Index | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability due to pain as measured by the Oswestry Disability Index | Change in enrollment to 16-week Oswestry Disability Index | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spine, lumbar, postoperative, physical activity