Physical Activity Intervention for Patients Following Lumbar Spine Surgery (PASS)
2022년 3월 30일 업데이트: 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
연구 개요
연구 유형
중재적
등록 (실제)
16
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Tennessee
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Nashville, Tennessee, 미국, 37212
- Vanderbilt University Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Recruitment rate
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Oswestry Disability Index
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Opioid Use
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Kristin R Archer, DPT, PhD, Vanderbilt University Medical Center
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2020년 10월 7일
기본 완료 (실제)
2021년 9월 24일
연구 완료 (실제)
2021년 12월 1일
연구 등록 날짜
최초 제출
2020년 10월 9일
QC 기준을 충족하는 최초 제출
2020년 10월 9일
처음 게시됨 (실제)
2020년 10월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 3월 31일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 3월 30일
마지막으로 확인됨
2022년 3월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 201126 (GSK eTrack)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니
IPD 계획 설명
Given the pilot nature of the trial, the IPD will not be available to other researchers.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .