- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04591249
Physical Activity Intervention for Patients Following Lumbar Spine Surgery (PASS)
30. mars 2022 oppdatert av: 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
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
16
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Tennessee
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Nashville, Tennessee, Forente stater, 37212
- Vanderbilt University Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Recruitment rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Oswestry Disability Index
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Opioid Use
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Kristin R Archer, DPT, PhD, Vanderbilt University Medical Center
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
7. oktober 2020
Primær fullføring (Faktiske)
24. september 2021
Studiet fullført (Faktiske)
1. desember 2021
Datoer for studieregistrering
Først innsendt
9. oktober 2020
Først innsendt som oppfylte QC-kriteriene
9. oktober 2020
Først lagt ut (Faktiske)
19. oktober 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
31. mars 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. mars 2022
Sist bekreftet
1. mars 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 201126 (GSK eTrack)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
IPD-planbeskrivelse
Given the pilot nature of the trial, the IPD will not be available to other researchers.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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