Condition or disease | Intervention/treatment | Phase |
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Spinal Degenerative Disorder | Behavioral: Physical activity intervention Other: Usual care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Telehealth Physical Activity Intervention After Lumbar Spine Surgery |
Actual Study Start Date : | June 28, 2021 |
Estimated Primary Completion Date : | May 31, 2023 |
Estimated Study Completion Date : | July 31, 2023 |
Arm | Intervention/treatment |
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Experimental: Physical Activity
Participants randomized to the physical activity intervention will receive usual postoperative care and a tele-health physical activity intervention.
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Behavioral: Physical activity intervention
Participants randomized to the physical activity intervention will receive a Fitbit and be enrolled in Fitabase (Fitbit tracking system). Participants will also participate in 8 tele-health sessions with a physical therapist. Sessions will involve setting weekly physical activity goals and reviewing the participant's physical activity on the Fitbit tracking system.
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Usual Care
Participants randomized to usual care will receive postoperative care as determined by their treating surgeon.
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Other: Usual care
Usual postoperative care includes surgeon-directed lifting restrictions, advice to stay active, and oral analgesics as needed. Physical therapy referral will be at the discretion of the surgeon. However, physical therapy is not typically started until 12 weeks after surgery.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shannon Block | 615-936-2438 | shannon.s.block@vumc.org |
United States, Tennessee | |
Vanderbilt University Medical Center | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Shannon Block | |
Principal Investigator: Kristin R Archer, PhD |
Principal Investigator: | Kristin A Swygert, Ph.D. | Vanderbilt University Medical Center |
Tracking Information | |||||
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First Submitted Date ICMJE | July 8, 2021 | ||||
First Posted Date ICMJE | July 20, 2021 | ||||
Last Update Posted Date | July 20, 2021 | ||||
Actual Study Start Date ICMJE | June 28, 2021 | ||||
Estimated Primary Completion Date | May 31, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Mean daily post-operative physical activity as measured by an accelerometer. [ Time Frame: Baseline to 12 months post-surgery ] Post-operative physical activity will be calculated as the average steps/day over a period of 7 days as measured by accelerometer
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Telehealth Activity Intervention After Lumbar Spine Surgery | ||||
Official Title ICMJE | Telehealth Physical Activity Intervention After Lumbar Spine Surgery | ||||
Brief Summary | The overall objective of this randomized controlled study is to examine the preliminary efficacy of a physical activity intervention that includes wearable technology and remote physical therapist support in patients undergoing lumbar spine surgery. Patients will be randomized to receive 8 sessions of a telehealth physical activity intervention (n=30) or usual postoperative care (n=30). The Investigator's central hypothesis is that a postoperative telehealth physical activity intervention will lead to greater improvements in objective physical activity (primary outcome) and patient-reported physical function, disability, and pain (secondary outcomes) compared to usual care in patients undergoing lumbar spine surgery. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Spinal Degenerative Disorder | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Coronado RA, Master H, White DK, Pennings JS, Bird ML, Devin CJ, Buchowski MS, Mathis SL, McGirt MJ, Cheng JS, Aaronson OS, Wegener ST, Archer KR. Early postoperative physical activity and function: a descriptive case series study of 53 patients after lumbar spine surgery. BMC Musculoskelet Disord. 2020 Nov 27;21(1):783. doi: 10.1186/s12891-020-03816-y. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 31, 2023 | ||||
Estimated Primary Completion Date | May 31, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04968821 | ||||
Other Study ID Numbers ICMJE | 211126 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Kristin Archer, Vanderbilt University Medical Center | ||||
Study Sponsor ICMJE | Vanderbilt University Medical Center | ||||
Collaborators ICMJE | Academy of Orthopaedic Physical Therapy | ||||
Investigators ICMJE |
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PRS Account | Vanderbilt University Medical Center | ||||
Verification Date | July 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |