Physical Activity Intervention for Patients Following Lumbar Spine Surgery

Not Applicable

Completed

• Conditions: Spinal Degenerative Disorder; Spinal Stenosis; Spondylosis
• Interventions: Other: Usual care; Behavioral: Physical activity intervention

• Registration Number: NCT04591249
• Lead Sponsor: Vanderbilt University Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-07
• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-19
• Primary Completion: 2021-09-24
• Study Completion: 2021-12-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Adults age 18 years or older, of both sexes and all races
2. 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.
3. Participants will be English speaking due to the feasibility of employing study personnel to deliver and assess the study intervention.

Exclusion Criteria

1. 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.
2. Patients having surgery for spinal deformity as the primary indication or surgery secondary to pseudarthrosis, trauma, infection, or tumor
3. Prior history of lumbar spine surgery
4. Presence of back and/or lower extremity pain < 3 month
5. History of neurological disorder, resulting in moderate to severe movement dysfunction
6. Unable to provide stable address and access to a telephone indicating the inability to participate in the intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual postoperative care	Usual care	Participants randomized to usual care group will receive postoperative care as determined by their treating surgeon.
Usual postoperative care + Physical activity intervention	Physical activity intervention	Participants randomized to the physical activity intervention group will receive usual postoperative care as determined by their treating surgeon and novel physical activity intervention.
Usual postoperative care + Physical activity intervention	Usual care	Participants randomized to the physical activity intervention group will receive usual postoperative care as determined by their treating surgeon and novel physical activity intervention.

Primary Outcome Measures

Name	Time	Method
Recruitment rate	At 2 weeks after spine surgery	Proportion of potential eligible participants successfully contacted who agreed to participate and randomized.
Adherence rate to study protocol at 3 months after spine surgery	From 2 weeks to 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	From 2 weeks to 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	From 2-weeks to 3-months after spine surgery	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	From 2-weeks to 3-months after spine surgery	During the intervention phase, the study physical therapist will document adverse events related to walking to assess safety.

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index	Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery	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	Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery	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	Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery	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	Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery	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	Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery	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	Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery	A research-grade triaxial accelerometer (Actigraph GT3x) will be used to quantify total number of steps per day.
Depressive symptoms	Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery	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	Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery	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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States