Physical Activity Intervention for Patients Following Lumbar Spine Surgery (PASS)
30. März 2022 aktualisiert von: 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
Studienübersicht
Status
Abgeschlossen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
16
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Tennessee
-
Nashville, Tennessee, Vereinigte Staaten, 37212
- Vanderbilt University Medical Center
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: Usual postoperative care
Participants randomized to usual care group will receive postoperative care as determined by their treating surgeon.
|
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.
|
|
Experimental: 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.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Recruitment rate
Zeitfenster: At 2 weeks after spine surgery
|
Proportion of potential eligible participants successfully contacted who agreed to participate and randomized.
|
At 2 weeks after spine surgery
|
|
Adherence rate to study protocol at 3 months after spine surgery
Zeitfenster: 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.
|
From 2 weeks to 3-months after spine surgery
|
|
Adherence rate to study protocol at 6 months after spine surgery
Zeitfenster: 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.
|
From 2 weeks to 6-months after spine surgery
|
|
Adherence to physical activity intervention
Zeitfenster: 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 |
From 2-weeks to 3-months after spine surgery
|
|
Number of adverse events
Zeitfenster: 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.
|
From 2-weeks to 3-months after spine surgery
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Oswestry Disability Index
Zeitfenster: 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.
|
Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
|
|
PROMIS Physical Function
Zeitfenster: 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.
|
Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
|
|
Numeric rating scale for back pain
Zeitfenster: 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.
|
Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
|
|
Numeric rating scale for leg pain
Zeitfenster: 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.
|
Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
|
|
Intensity of physical activity
Zeitfenster: 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.
|
Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
|
|
Physical activity volume
Zeitfenster: 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.
|
Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
|
|
Depressive symptoms
Zeitfenster: 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.
|
Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
|
|
Fear of movement
Zeitfenster: 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.
|
Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Opioid Use
Zeitfenster: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
|
A single-item Patient-reported opioid use questionnaire (yes vs. no).
|
Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Studienleiter: Kristin R Archer, DPT, PhD, Vanderbilt University Medical Center
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
7. Oktober 2020
Primärer Abschluss (Tatsächlich)
24. September 2021
Studienabschluss (Tatsächlich)
1. Dezember 2021
Studienanmeldedaten
Zuerst eingereicht
9. Oktober 2020
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Oktober 2020
Zuerst gepostet (Tatsächlich)
19. Oktober 2020
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
31. März 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
30. März 2022
Zuletzt verifiziert
1. März 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 201126 (GSK eTrack)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Nein
Beschreibung des IPD-Plans
Given the pilot nature of the trial, the IPD will not be available to other researchers.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .