Increasing Long-Term Physical Activity After Lumbar Spine Surgery

Not Applicable

Active, not recruiting

• Conditions: Lumbar Spine Degenerative Changes
• Interventions: Behavioral: Education; Behavioral: Education/Self-efficacy

• Registration Number: NCT02611427
• Lead Sponsor: Hospital for Special Surgery, New York

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).

Study Timeline

• Study First Submitted: 2015-11-10
• Study Start: 2015-11-11
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-08
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 260

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education	Education	Booklet about physical activity
Education/Self-efficacy	Education/Self-efficacy	Booklet about physical activity, movement monitoring device, encouragement

Primary Outcome Measures

Name	Time	Method
Weekly energy expenditure in kilocalories per week as measured by the Paffenbarger Physical Activity and Exercise Index	16 weeks	Change in enrollment to 16-week Paffenbarger Physical Activity and Exercise Index

Secondary Outcome Measures

Name	Time	Method
Disability due to pain as measured by the Oswestry Disability Index	16 weeks	Change in enrollment to 16-week Oswestry Disability Index

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States