Influence of Pre-operative Back Muscle Exercise on Post-operative Outcomes After Spine Surgery

Обзор

The purpose of this research study is to gather more information about how improving back muscle function before surgery might influence what happens to the spine and function after surgery. This may assist in developing ways to improve surgical outcomes and determine the benefit of pre-operative exercise, if any.

Подробное описание

The investigators intend to enroll patients from UCSD spine clinic. The investigators will include patients who are indicated for a spine surgery. Once participants are identified to be surgical candidates, and have an estimated surgical date that is 4-6 weeks from identification, the participants may undergo pre-operative procedures including a pre-operative evaluation and treatment by a physical therapist, data collection (demographics, medical history, etc.), and filling out relevant questionnaires. Patients will undergo their surgery as scheduled with the spine surgeon as part of their planned standard care unless the surgeon decides that the surgery is no longer necessary. Participation in research does not influence the surgeon's decision. Post-operatively, participants may be asked to undergo a post-operative evaluation and fill out questionnaires.

Upon identification of eligibility, participants may be randomized to one of two study arms using a random number generator. If group characteristics are observed to be unbalanced using this approach, participants may be matched according to demographic or surgical features:

1. Pre-habilitation treatment arm 2. Standard of Care arm Participants in the standard of care arm will undergo all pre-operative activities recommended by their surgeon as per standard care.

Вмешательства

• Поведенческое Preoperative Resistance Exercise
  Participants will have been deemed to be medically safe to participate in exercise-based physical therapy based on their physician recommendation and may also undergo an in-person evaluation by a licensed physical therapist to evaluate their physical capacity. This will inform the frequency and intensity of exercise prescription according to a participant's identified physical impairments and activity tolerance levels. Based on this information, an exercise program will be implemented either via

Первичные конечные точки

• Surgical Revision [Срок оценки: 1 year]

Вторичные конечные точки (3)

• Length of stay [Срок оценки: 3 months]
• Numeric Pain Rating Scale [Срок оценки: 1 year]
• Disability [Срок оценки: 1 year]

Критерии участия

Критерии включения

• \- Individuals undergoing spinal surgery
• Individuals who have been deemed medically safe to participate in an exercise-based physical therapy program

Критерии исключения

• \- Individuals with comorbid conditions or spinal injury inappropriate for participating in an exercise-based physical therapy program as determined by the surgeon (e.g. unstable vertebral fracture)
• Individuals that do not have the ability to commit to the therapy schedule either in-clinic or using the web-based interface
• Non-english speaking individuals (some questionnaires are validated only in English)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• UC San Diego — La Jolla

Идентификаторы

NCT: NCT06808022 · 803198

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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