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临床试验/NCT07596238
NCT07596238已完成不适用

Structured Swimming-Based Rehabilitation Improves Functional Recovery After Thoracolumbar Spinal Fusion: A Prospective Comparative Observational Cohort Study

Tra Vinh General Hospital1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
124
试验地点
1

研究概览

简要总结

This study evaluates the effectiveness and safety of a structured swimming-based rehabilitation program in patients undergoing thoracolumbar spinal fusion. Postoperative rehabilitation after spinal fusion varies widely, and evidence supporting specific exercise strategies remains limited.

In this prospective observational cohort study, patients undergoing thoracolumbar spinal fusion are allocated to either a structured swimming-based rehabilitation program or a standard rehabilitation program. The swimming program is initiated 6 to 8 weeks after surgery and is performed three times per week for 12 weeks.

The primary outcome is the change in functional disability as measured by the Oswestry Disability Index at 12 weeks. Secondary outcomes include pain intensity assessed using the Visual Analog Scale and quality of life assessed using the Short Form-36 questionnaire.

The results of this study aim to determine whether structured aquatic exercise can improve functional recovery, reduce pain, and enhance quality of life following thoracolumbar spinal fusion.

详细描述

Thoracolumbar spinal fusion is commonly performed for degenerative, traumatic, and osteoporotic spinal conditions. Despite advances in surgical techniques, postoperative recovery remains heterogeneous, with many patients experiencing persistent pain and functional limitations.

Rehabilitation plays a critical role in postoperative recovery; however, optimal rehabilitation strategies following spinal fusion are not well established. Aquatic exercise has unique biomechanical advantages, including reduced axial loading, buoyancy-assisted movement, and increased resistance, which may facilitate earlier mobilization and neuromuscular reconditioning.

This study is a prospective comparative observational cohort study conducted at Tra Vinh General Hospital, Vietnam. A total of 124 patients undergoing thoracolumbar spinal fusion with pedicle screw instrumentation are included. Patients are allocated into two groups based on clinical recommendation and patient preference: a structured swimming-based rehabilitation group and a standard rehabilitation group.

The swimming-based rehabilitation program is initiated 6 to 8 weeks after surgery and consists of three sessions per week for 12 weeks. Each session includes warm-up exercises, low-impact swimming (primarily backstroke and freestyle), progressive endurance training, and cool-down exercises. Initial sessions are supervised to ensure safety and proper technique.

The standard rehabilitation group follows a conventional land-based program including ambulation training, core stabilization, and flexibility exercises with similar frequency and duration.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 years or older
  • Patients undergoing thoracolumbar spinal fusion with pedicle screw instrumentation
  • Patients able to participate in rehabilitation programs
  • Patients who provide informed consent

排除标准

  • Patients with severe neurological deficits preventing rehabilitation
  • Patients with severe cardiopulmonary comorbidities contraindicating exercise
  • Patients with postoperative complications requiring reoperation
  • Patients unable to follow the rehabilitation protocol

研究者

发起方
Tra Vinh General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Le Hoang Nha

Neurosurgeon

Tra Vinh General Hospital

研究点 (1)

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