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Physical Activity Intervention for Patients Following Lumbar Spine Surgery (PASS)

30. marts 2022 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

16

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37212
        • Vanderbilt University Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Usual postoperative care
Participants randomized to usual care group will receive postoperative care as determined by their treating surgeon.
Andet: Usual care
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.
Eksperimentel: 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.
Andet: Usual care
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.
Adfærdsmæssigt: Physical activity intervention
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recruitment rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Oswestry Disability Index
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Opioid Use
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Vanderbilt University Medical Center

Efterforskere

  • Studieleder: Kristin R Archer, DPT, PhD, Vanderbilt University Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. oktober 2020

Primær færdiggørelse (Faktiske)

24. september 2021

Studieafslutning (Faktiske)

1. december 2021

Datoer for studieregistrering

Først indsendt

9. oktober 2020

Først indsendt, der opfyldte QC-kriterier

9. oktober 2020

Først opslået (Faktiske)

19. oktober 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 201126 (GSK eTrack)

Plan for individuelle deltagerdata (IPD)

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Ingen

IPD-planbeskrivelse

Given the pilot nature of the trial, the IPD will not be available to other researchers.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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