Increasing Long-Term Physical Activity After Lumbar Spine Surgery

NCT ID: NCT02611427

Last Updated: 2025-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-11

Study Completion Date

2026-06-30

Brief Summary

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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

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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).

Conditions

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Lumbar Spine Degenerative Changes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Education/Self-efficacy

Booklet about physical activity, movement monitoring device, encouragement

Group Type ACTIVE_COMPARATOR

Education/Self-efficacy

Intervention Type BEHAVIORAL

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.

Education

Booklet about physical activity

Group Type ACTIVE_COMPARATOR

Education

Intervention Type BEHAVIORAL

The education group will receive information about safe physical activity.

Interventions

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Education/Self-efficacy

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.

Intervention Type BEHAVIORAL

Education

The education group will receive information about safe physical activity.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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

* Exclusion Criteria: Patients will be excluded if they had any new cardiopulmonary symptoms since surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carol A Mancuso, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

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Hospital for Special Surgery

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22269593 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21183562 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24088972 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23173979 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25291976 (View on PubMed)

Other Identifiers

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2015-142

Identifier Type: -

Identifier Source: org_study_id

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