Back to resultsPhysical Activity Intervention for Patients Following Lumbar Spine Surgery (PASS)
Primary Purpose
Spinal Degenerative Disorder, Spinal Stenosis, Spondylosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical activity intervention
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Degenerative Disorder focused on measuring physical activity, wearable technology, behavioral model, funciton, disability, pain
Eligibility Criteria
Inclusion Criteria:
- Adults age 18 years or older, of both sexes and all races
- Scheduled for surgical treatment of a lumbar degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis (i.e., fusion) procedures.
- Participants will be English speaking due to the feasibility of employing study personnel to deliver and assess the study intervention.
Exclusion Criteria:
- Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy will be excluded because individuals having these minimally invasive surgical techniques tend to have a less severe case of lumbar degeneration.
- Patients having surgery for spinal deformity as the primary indication or surgery secondary to pseudarthrosis, trauma, infection, or tumor
- Prior history of lumbar spine surgery
- Presence of back and/or lower extremity pain < 3 month
- History of neurological disorder, resulting in moderate to severe movement dysfunction
- Unable to provide stable address and access to a telephone indicating the inability to participate in the intervention.
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Usual postoperative care
Usual postoperative care + Physical activity intervention
Arm Description
Participants randomized to usual care group will receive postoperative care as determined by their treating surgeon.
Participants randomized to the physical activity intervention group will receive usual postoperative care as determined by their treating surgeon and novel physical activity intervention.
Outcomes
Primary Outcome Measures
Recruitment rate
Proportion of potential eligible participants successfully contacted who agreed to participate and randomized.
Adherence rate to study protocol at 3 months after spine surgery
Proportion of participants who will complete the assessment at 2 weeks and 3 months after spine surgery.
Adherence rate to study protocol at 6 months after spine surgery
Proportion of participants who will complete the assessment at 2 weeks and 6 months after spine surgery.
Adherence to physical activity intervention
Number of weekly step goals completed by participant, which will be examined via Fitabase.
In addition, number of weekly Zoom calls completed with the physical therapist will be recorded
Number of adverse events
During the intervention phase, the study physical therapist will document adverse events related to walking to assess safety.
Secondary Outcome Measures
Oswestry Disability Index
A 10-item questionnaire will be used to measure condition-specific disability that assesses the impact of lumbar spinal disorders on activities of daily living. Each item is measured from 0 to 5, representing low and high disability, respectively. Total score ranges from 0 to 50.
PROMIS Physical Function
PROMIS Physical Function 4-item short form will be used to measure physical function. Each item is measured from 1 to 5, representing low to high physical function, respectively. Total score ranges from 4 to 20.
Numeric rating scale for back pain
Numeric rating scale will be used to assess the pain intensity using the single-item for back, which is scored from 0 to 10, representing no pain and the worst pain, respectively.
Numeric rating scale for leg pain
Numeric rating scale will be used to assess the pain intensity using the single-item for leg, which is scored from 0 to 10, representing no pain and the worst pain, respectively.
Intensity of physical activity
A research-grade triaxial accelerometer (Actigraph GT3x) will be used to quantify time spent in different intensities of physical activity per day.
Physical activity volume
A research-grade triaxial accelerometer (Actigraph GT3x) will be used to quantify total number of steps per day.
Depressive symptoms
PROMIS Depression 4 item short form will be used to measure depressive symtpoms. Each item is measured from 1 to 5, representing low to high depressive symptoms. Total score ranges from 4 to 20.
Fear of movement
A 13-item Tampa Scale for Kinesiophobia will be used to measure fear of movement. It has two sub-scales (activity avoidance and fear of pain) and the total score ranges from 13 to 52 with higher scores indicating greater fear of movement.
Full Information
NCT ID
NCT04591249
First Posted
October 9, 2020
Last Updated
March 30, 2022
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04591249
Brief Title
Physical Activity Intervention for Patients Following Lumbar Spine Surgery
Acronym
PASS
Official Title
Developing a Novel Physical Activity Intervention for Patients Following Lumbar Spine Surgery (PASS Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
September 24, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There is a critical need to target physical activity during postoperative management to optimize long-term recovery after lumbar spine surgery. The overall objective of this study is to conduct a two-group randomized control trial (RCT) to examine the feasibility and acceptability of a physical activity telehealth intervention delivered by a physical therapist for improving disability, physical function, pain, and physical activity compared to usual care after spine surgery for a degenerative lumbar condition. The physical activity intervention will include wearable technology and remote physical therapist support to counsel patients on a realistic progression of physical activity (steps per day). The central hypothesis is that this 8-week physical activity intervention performed at two weeks after surgery will be feasible and acceptable. The results of our randomized trial will be used to support a large multi-site clinical trial to test the effectiveness and implementation of this intervention
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Degenerative Disorder, Spinal Stenosis, Spondylosis
Keywords
physical activity, wearable technology, behavioral model, funciton, disability, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-group, single-center randomized, controlled study in 30 patients undergoing spine surgery for a lumbar degenerative condition to examine the feasibility and acceptability of an 8-week remote physical activity intervention.
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual postoperative care
Arm Type
Other
Arm Description
Participants randomized to usual care group will receive postoperative care as determined by their treating surgeon.
Arm Title
Usual postoperative care + Physical activity intervention
Arm Type
Experimental
Arm Description
Participants randomized to the physical activity intervention group will receive usual postoperative care as determined by their treating surgeon and novel physical activity intervention.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity intervention
Intervention Description
Participants will 1) receive Fitbit, 2) be enrolled in a secure electronic platform to access Fitbit data, 3) receive 8-week remote counseling by a physical therapist that will include motivational interviewing and creating SMART goals (1 session per week) through a web-based teleconference platform, and 4) receive usual postoperative care directed by their surgeon. The first session will be 45 minutes and sessions 2-8 will be 30 minutes each. During the sessions, participant's confidence in meeting daily step goals will be assessed using a 0-10 scale. If self-reported confidence to meet their goal is <8, the physical therapist will help participants modify their goal using techniques such as problem-solving, positive statements and affirmations. Progression will be made only if daily steps goals are met for at least 4 out of 7 days a week. If this weekly step goal is not met, a physical therapist will help the participant identify solutions for realistic progression.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Participants will receive postoperative care as determined by their treating surgeon. This includes 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.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
Proportion of potential eligible participants successfully contacted who agreed to participate and randomized.
Time Frame
At 2 weeks after spine surgery
Title
Adherence rate to study protocol at 3 months after spine surgery
Description
Proportion of participants who will complete the assessment at 2 weeks and 3 months after spine surgery.
Time Frame
From 2 weeks to 3-months after spine surgery
Title
Adherence rate to study protocol at 6 months after spine surgery
Description
Proportion of participants who will complete the assessment at 2 weeks and 6 months after spine surgery.
Time Frame
From 2 weeks to 6-months after spine surgery
Title
Adherence to physical activity intervention
Description
Number of weekly step goals completed by participant, which will be examined via Fitabase.
In addition, number of weekly Zoom calls completed with the physical therapist will be recorded
Time Frame
From 2-weeks to 3-months after spine surgery
Title
Number of adverse events
Description
During the intervention phase, the study physical therapist will document adverse events related to walking to assess safety.
Time Frame
From 2-weeks to 3-months after spine surgery
Secondary Outcome Measure Information:
Title
Oswestry Disability Index
Description
A 10-item questionnaire will be used to measure condition-specific disability that assesses the impact of lumbar spinal disorders on activities of daily living. Each item is measured from 0 to 5, representing low and high disability, respectively. Total score ranges from 0 to 50.
Time Frame
Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Title
PROMIS Physical Function
Description
PROMIS Physical Function 4-item short form will be used to measure physical function. Each item is measured from 1 to 5, representing low to high physical function, respectively. Total score ranges from 4 to 20.
Time Frame
Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Title
Numeric rating scale for back pain
Description
Numeric rating scale will be used to assess the pain intensity using the single-item for back, which is scored from 0 to 10, representing no pain and the worst pain, respectively.
Time Frame
Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Title
Numeric rating scale for leg pain
Description
Numeric rating scale will be used to assess the pain intensity using the single-item for leg, which is scored from 0 to 10, representing no pain and the worst pain, respectively.
Time Frame
Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Title
Intensity of physical activity
Description
A research-grade triaxial accelerometer (Actigraph GT3x) will be used to quantify time spent in different intensities of physical activity per day.
Time Frame
Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Title
Physical activity volume
Description
A research-grade triaxial accelerometer (Actigraph GT3x) will be used to quantify total number of steps per day.
Time Frame
Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Title
Depressive symptoms
Description
PROMIS Depression 4 item short form will be used to measure depressive symtpoms. Each item is measured from 1 to 5, representing low to high depressive symptoms. Total score ranges from 4 to 20.
Time Frame
Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Title
Fear of movement
Description
A 13-item Tampa Scale for Kinesiophobia will be used to measure fear of movement. It has two sub-scales (activity avoidance and fear of pain) and the total score ranges from 13 to 52 with higher scores indicating greater fear of movement.
Time Frame
Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Other Pre-specified Outcome Measures:
Title
Opioid Use
Description
A single-item Patient-reported opioid use questionnaire (yes vs. no).
Time Frame
Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults age 18 years or older, of both sexes and all races
Scheduled for surgical treatment of a lumbar degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis (i.e., fusion) procedures.
Participants will be English speaking due to the feasibility of employing study personnel to deliver and assess the study intervention.
Exclusion Criteria:
Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy will be excluded because individuals having these minimally invasive surgical techniques tend to have a less severe case of lumbar degeneration.
Patients having surgery for spinal deformity as the primary indication or surgery secondary to pseudarthrosis, trauma, infection, or tumor
Prior history of lumbar spine surgery
Presence of back and/or lower extremity pain < 3 month
History of neurological disorder, resulting in moderate to severe movement dysfunction
Unable to provide stable address and access to a telephone indicating the inability to participate in the intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin R Archer, DPT, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Given the pilot nature of the trial, the IPD will not be available to other researchers.
Links:
URL
https://www.vumc.org/musculoskeletal-research/spine
Description
Website that provides brief description of the PASS trial
Learn more about this trial
Physical Activity Intervention for Patients Following Lumbar Spine Surgery
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