Spinal Degenerative DisorderPASSNCT04591249
Physical Activity Intervention for Patients Following Lumbar Spine Surgery
A study testing Physical activity intervention in people with Spinal Degenerative Disorder and Spinal Stenosis, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Degenerative Disorder, Spinal Stenosis, Spondylosis
- What is being tested?
- Physical activity intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2020to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: Developing a Novel Physical Activity Intervention for Patients Following Lumbar Spine Surgery (PASS Trial)
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
- Conditions
- Spinal Degenerative Disorder, Spinal Stenosis, Spondylosis
- Being tested
- Physical activity intervention, Usual care
- Keywords
- physical activity, wearable technology, behavioral model, funciton, disability, pain
- Medical subject headings
- Spinal Stenosis, Spondylosis, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionBehavioural
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.
Usual careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual postoperative care | Other | Participants randomized to usual care group will receive postoperative care as determined by their treating surgeon. Receives: Other: Usual care |
| Usual postoperative care + Physical activity intervention | Experimental | Participants randomized to the physical activity intervention group will receive usual postoperative care as determined by their treating surgeon and novel physical activity intervention. Receives: Behavioral: Physical activity intervention; Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Proportion of potential eligible participants successfully contacted who agreed to participate and randomized.
Measured: At 2 weeks after spine surgery
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.
Measured: From 2 weeks to 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.
Measured: From 2 weeks to 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
Measured: From 2-weeks to 3-months after spine surgery
Number of adverse events
During the intervention phase, the study physical therapist will document adverse events related to walking to assess safety.
Measured: From 2-weeks to 3-months after spine surgery
Secondary outcomes (8)
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.
Measured: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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.
Measured: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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.
Measured: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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.
Measured: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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.
Measured: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Physical activity volume
A research-grade triaxial accelerometer (Actigraph GT3x) will be used to quantify total number of steps per day.
Measured: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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.
Measured: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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.
Measured: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start7 Oct 2020
- Primary completion24 Sep 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Degenerative DisorderStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiral Master, Vanderbilt University Medical Center
- Investigators
- Kristin R Archer, DPT, PhD, Study director, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591249
- Sponsor's protocol ID
- 201126
- Acronym
- PASS
- Status last verified
- Mar 2022
- First submitted
- 9 Oct 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given the pilot nature of the trial, the IPD will not be available to other researchers.
Publications
Master H, Coronado RA, Whitaker S, Block S, Vanston SW, Pennings JS, Gupta R, Robinette P, Stephens B, Abtahi A, Schwarz J, Archer KR. Combining Wearable Technology and Telehealth Counseling for Rehabilitation After Lumbar Spine Surgery: Feasibility and Acceptability of a Physical Activity Intervention. Phys Ther. 2024 Feb 1;104(2):pzad096. doi: 10.1093/ptj/pzad096.
PubMed 37478463
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Novel Physical Activity Intervention for Patients Following Lumbar Spine Surgery (PASS Trial)
- ClinicalTrials.gov ID
- NCT04591249
- Acronym / sponsor ID
- PASS / 201126
- Conditions
- Spinal Degenerative Disorder, Spinal Stenosis, Spondylosis
- Keywords
- physical activity, wearable technology, behavioral model, funciton, disability, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 24 Sep 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual postoperative care | Other | Other: Usual careParticipants randomized to usual care group will receive postoperative care as determined by their treating surgeon. |
| Usual postoperative care + Physical activity intervention | Experimental | Behavioral: Physical activity intervention, Other: Usual careParticipants randomized to the physical activity intervention group will receive usual postoperative care as determined by their treating surgeon and novel physical activity intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity interventionParticipants 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. | Behavioural | Usual postoperative care + Physical activity intervention |
| Usual careParticipants 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. | Other | Usual postoperative care, Usual postoperative care + Physical activity intervention |
Primary outcome
Recruitment rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
8 secondary outcomes
Oswestry Disability Index
Time frame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
PROMIS Physical Function
Time frame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Numeric rating scale for back pain
Time frame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Numeric rating scale for leg pain
Time frame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Intensity of physical activity
Time frame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Physical activity volume
Time frame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Depressive symptoms
Time frame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Fear of movement
Time frame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 37478463Master H, Coronado RA, Whitaker S, Block S, Vanston SW, Pennings JS, Gupta R, Robinette P, Stephens B, Abtahi A, Schwarz J, Archer KR. Combining Wearable Technology and Telehealth Counseling for Rehabilitation After Lumbar Spine Surgery: Feasibility and Acceptability of a Physical Activity Intervention. Phys Ther. 2024 Feb 1;104(2):pzad096. doi: 10.1093/ptj/pzad096.
- Website that provides brief description of the PASS trialLink provided by the sponsor.
- Individual participant dataSharing planned: No. Given the pilot nature of the trial, the IPD will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin R Archer, DPT, PhD study director
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention in people with Spinal Degenerative Disorder and Spinal Stenosis, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: At 2 weeks after spine surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04591249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.