Physical Activity Intervention for Patients Following Lumbar Spine Surgery (PASS)
30 mars 2022 mis à jour par: 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
Aperçu de l'étude
Statut
Complété
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
16
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Tennessee
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Nashville, Tennessee, États-Unis, 37212
- Vanderbilt University Medical Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Recruitment rate
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Oswestry Disability Index
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Opioid Use
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Kristin R Archer, DPT, PhD, Vanderbilt University Medical Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
7 octobre 2020
Achèvement primaire (Réel)
24 septembre 2021
Achèvement de l'étude (Réel)
1 décembre 2021
Dates d'inscription aux études
Première soumission
9 octobre 2020
Première soumission répondant aux critères de contrôle qualité
9 octobre 2020
Première publication (Réel)
19 octobre 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
31 mars 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 mars 2022
Dernière vérification
1 mars 2022
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 201126 (GSK eTrack)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Description du régime IPD
Given the pilot nature of the trial, the IPD will not be available to other researchers.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .