Physical Activity Intervention for Patients Following Lumbar Spine Surgery (PASS)
30 marca 2022 zaktualizowane przez: 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
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
16
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Tennessee
-
Nashville, Tennessee, Stany Zjednoczone, 37212
- Vanderbilt University Medical Center
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Inny: 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.
|
|
Eksperymentalny: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Recruitment rate
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Oswestry Disability Index
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Opioid Use
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Dyrektor Studium: Kristin R Archer, DPT, PhD, Vanderbilt University Medical Center
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
7 października 2020
Zakończenie podstawowe (Rzeczywisty)
24 września 2021
Ukończenie studiów (Rzeczywisty)
1 grudnia 2021
Daty rejestracji na studia
Pierwszy przesłany
9 października 2020
Pierwszy przesłany, który spełnia kryteria kontroli jakości
9 października 2020
Pierwszy wysłany (Rzeczywisty)
19 października 2020
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
31 marca 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
30 marca 2022
Ostatnia weryfikacja
1 marca 2022
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 201126 (GSK eTrack)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Nie
Opis planu IPD
Given the pilot nature of the trial, the IPD will not be available to other researchers.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .