New York, New York 10021


Purpose:

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.


Study summary:

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).


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.


Study is Available At:


Original ID:

2015-142


NCT ID:

NCT02611427


Secondary ID:


Study Acronym:


Brief Title:

Increasing Long-Term Physical Activity After Lumbar Spine Surgery


Official Title:

Increasing Long-Term Physical Activity After Lumbar Spine Surgery


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Hospital for Special Surgery, New York


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

350


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Carol A Mancuso, MD
Principal Investigator
Hospital for Special Surgery, New York
Primary Contact:Carol A Mancuso, MD
212-774-7508
mancusoc@hss.edu
Backup Contact:Roland Duculan, MD
646-714-6046
duculanr@hss.edu

Study Dates

Start Date:November 11, 2015
Completion Date:October 2020
Completion Type:Anticipated
Primary Completion Date:October 2020
Primary Completion Type:Anticipated
Verification Date:January 2019
Last Changed Date:January 31, 2019
First Received Date:November 10, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Disability due to pain as measured by the Oswestry Disability Index
Time Frame:16 weeks
Safety Issues:False
Description:Change in enrollment to 16-week Oswestry Disability Index
Outcome Type:Primary Outcome
Measure:Weekly energy expenditure in kilocalories per week as measured by the Paffenbarger Physical Activity and Exercise Index
Time Frame:16 weeks
Safety Issues:False
Description:Change in enrollment to 16-week Paffenbarger Physical Activity and Exercise Index

Study Interventions

Intervention Type:Behavioral
Name:Education/Self-efficacy
Description: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.
Arm Name:Education/Self-efficacy
Intervention Type:Behavioral
Name:Education
Description:The education group will receive information about safe physical activity.
Arm Name:Education

Study Arms

Study Arm Type:Active Comparator
Arm Name:Education
Description:Booklet about physical activity
Study Arm Type:Active Comparator
Arm Name:Education/Self-efficacy
Description:Booklet about physical activity, movement monitoring device, encouragement

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Hospital for Special Surgery, New York

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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.
PMID:22269593
Reference Type:Reference
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.
PMID:21183562
Reference Type:Reference
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.
PMID:24088972
Reference Type:Reference
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.
PMID:23173979
Reference Type:Reference
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.
PMID:25291976

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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