Clinical trial NCT02611427: Increasing Long-Term Physical Activity After Lumbar Spine Surgery
Official title: Increasing Long-Term Physical Activity After Lumbar Spine Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lumbar Spine Degenerative Changes
Keywords: spine
lumbar
postoperative
physical activity
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Primary outcomes:
measure: Weekly energy expenditure in kilocalories per week as measured by the Paffenbarger Physical Activity and Exercise Index
timeFrame: 16 weeks
Secondary outcomes:
measure: Disability due to pain as measured by the Oswestry Disability Index
timeFrame: 16 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Carol A Mancuso, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mancuso CA, Choi TN, Westermann H, Wenderoth S, Hollenberg JP, Wells MT, Isen AM, Jobe JB, Allegrante JP, Charlson ME. Increasing physical activity in patients with asthma through positive affect and self-affirmation: a randomized trial. Arch Intern Med. 2012 Feb 27;172(4):337-43. doi: 10.1001/archinternmed.2011.1316. Epub 2012 Jan 23.
citation: Mancuso CA, Perna M, Sargent AB, Salmon JE. Perceptions and measurements of physical activity in patients with systemic lupus erythematosus. Lupus. 2011 Mar;20(3):231-42. doi: 10.1177/0961203310383737. Epub 2010 Dec 23.
citation: Mancuso CA, Cammisa FP, Sama AA, Hughes AP, Ghomrawi HM, Girardi FP. Development and testing of an expectations survey for patients undergoing lumbar spine surgery. J Bone Joint Surg Am. 2013 Oct 2;95(19):1793-800. doi: 10.2106/JBJS.L.00338.
citation: Mancuso CA, Choi TN, Westermann H, Wenderoth S, Wells MT, Charlson ME. Improvement in asthma quality of life in patients enrolled in a prospective study to increase lifestyle physical activity. J Asthma. 2013 Feb;50(1):103-7. doi: 10.3109/02770903.2012.743150. Epub 2012 Nov 22.
citation: Mancuso CA, Duculan R, Stal M, Girardi FP. Patients' expectations of lumbar spine surgery. Eur Spine J. 2015 Nov;24(11):2362-9. doi: 10.1007/s00586-014-3597-z. Epub 2014 Oct 8.