Physical Activity Intervention for Patients Following Lumbar Spine Surgery (PASS)
30 maart 2022 bijgewerkt door: Hiral Master, Vanderbilt University Medical Center
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
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
16
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Tennessee
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Nashville, Tennessee, Verenigde Staten, 37212
- Vanderbilt University Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Ander: Usual postoperative care
Participants randomized to usual care group will receive postoperative care as determined by their treating surgeon.
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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.
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Experimenteel: Usual postoperative care + 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.
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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.
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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Recruitment rate
Tijdsspanne: At 2 weeks after spine surgery
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Proportion of potential eligible participants successfully contacted who agreed to participate and randomized.
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At 2 weeks after spine surgery
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Adherence rate to study protocol at 3 months after spine surgery
Tijdsspanne: From 2 weeks to 3-months after spine surgery
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Proportion of participants who will complete the assessment at 2 weeks and 3 months after spine surgery.
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From 2 weeks to 3-months after spine surgery
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Adherence rate to study protocol at 6 months after spine surgery
Tijdsspanne: From 2 weeks to 6-months after spine surgery
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Proportion of participants who will complete the assessment at 2 weeks and 6 months after spine surgery.
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From 2 weeks to 6-months after spine surgery
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Adherence to physical activity intervention
Tijdsspanne: From 2-weeks to 3-months after spine surgery
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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 |
From 2-weeks to 3-months after spine surgery
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Number of adverse events
Tijdsspanne: From 2-weeks to 3-months after spine surgery
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During the intervention phase, the study physical therapist will document adverse events related to walking to assess safety.
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From 2-weeks to 3-months after spine surgery
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Oswestry Disability Index
Tijdsspanne: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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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.
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Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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PROMIS Physical Function
Tijdsspanne: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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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.
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Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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Numeric rating scale for back pain
Tijdsspanne: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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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.
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Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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Numeric rating scale for leg pain
Tijdsspanne: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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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.
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Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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Intensity of physical activity
Tijdsspanne: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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A research-grade triaxial accelerometer (Actigraph GT3x) will be used to quantify time spent in different intensities of physical activity per day.
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Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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Physical activity volume
Tijdsspanne: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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A research-grade triaxial accelerometer (Actigraph GT3x) will be used to quantify total number of steps per day.
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Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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Depressive symptoms
Tijdsspanne: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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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.
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Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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Fear of movement
Tijdsspanne: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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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.
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Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Opioid Use
Tijdsspanne: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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A single-item Patient-reported opioid use questionnaire (yes vs. no).
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Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Studie directeur: Kristin R Archer, DPT, PhD, Vanderbilt University Medical Center
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
7 oktober 2020
Primaire voltooiing (Werkelijk)
24 september 2021
Studie voltooiing (Werkelijk)
1 december 2021
Studieregistratiedata
Eerst ingediend
9 oktober 2020
Eerst ingediend dat voldeed aan de QC-criteria
9 oktober 2020
Eerst geplaatst (Werkelijk)
19 oktober 2020
Updates van studierecords
Laatste update geplaatst (Werkelijk)
31 maart 2022
Laatste update ingediend die voldeed aan QC-criteria
30 maart 2022
Laatst geverifieerd
1 maart 2022
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 201126 (GSK eTrack)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Nee
Beschrijving IPD-plan
Given the pilot nature of the trial, the IPD will not be available to other researchers.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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