Physical Activity Intervention for Patients Following Lumbar Spine Surgery (PASS)
2022年3月30日 更新者：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
調査の概要
研究の種類
介入
入学 (実際)
16
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Tennessee
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Nashville、Tennessee、アメリカ、37212
- Vanderbilt University Medical Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recruitment rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Oswestry Disability Index
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Opioid Use
時間枠：Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
|
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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Kristin R Archer, DPT, PhD、Vanderbilt University Medical Center
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2020年10月7日
一次修了 (実際)
2021年9月24日
研究の完了 (実際)
2021年12月1日
試験登録日
最初に提出
2020年10月9日
QC基準を満たした最初の提出物
2020年10月9日
最初の投稿 (実際)
2020年10月19日
学習記録の更新
投稿された最後の更新 (実際)
2022年3月31日
QC基準を満たした最後の更新が送信されました
2022年3月30日
最終確認日
2022年3月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 201126 (GSK eTrack)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Given the pilot nature of the trial, the IPD will not be available to other researchers.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
脊柱管狭窄症の臨床試験
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Memorial Sloan Kettering Cancer CenterUniversity of Pisa; University of California, San Francisco; The Champalimaud Centre, Lisbon,...積極的、募集していないメラノーマ | 肉腫 | 卵巣がん | 骨 | 軟部組織 | リンパ節 | CNS-Spinal CD/MEMBR、NOSアメリカ, イタリア, ポルトガル
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