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NCT Number: NCT07596238

Swimming-Based Rehabilitation for Recovery After Thoracolumbar Spinal Fusion

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tra Vinh General Hospital

Vĩnh Long, Vinh Long, 890000, Vietnam

About this study

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.

The primary outcome is the change in Oswestry Disability Index (ODI) from baseline to 12 weeks. Secondary outcomes include pain intensity measured using the Visual Analog Scale (VAS) and quality of life assessed using the Short Form-36 (SF-36). Outcomes are assessed at baseline, 6 weeks, and 12 weeks.

Statistical analysis includes between-group comparisons using appropriate parametric or non-parametric tests and multivariate regression to adjust for baseline differences. Effect sizes are reported with 95% confidence intervals.

This study aims to evaluate whether structured swimming-based rehabilitation improves functional recovery, pain reduction, and quality of life compared with standard rehabilitation after thoracolumbar spinal fusion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Swimming-Based Rehabilitation

Behavioral

Structured aquatic exercise program initiated 6-8 weeks after thoracolumbar spinal fusion, performed three sessions per week for 12 weeks, including warm-up, swimming, and cool-down exercises.

standard rehabilitation

Behavioral

Conventional land-based postoperative rehabilitation including ambulation training, core stabilization, and flexibility exercises with similar frequency and duration.

Primary outcomes

  1. Change in Oswestry Disability Index (ODI)

    Time frame: Baseline to 12 weeks

    The Oswestry Disability Index (ODI) assesses functional disability, with scores ranging from 0 to 100. Higher scores indicate greater disability. The outcome measure is the change in ODI from baseline to 12 weeks after initiation of rehabilitation.

Secondary outcomes

  1. Pain Intensity Measured by Visual Analog Scale (VAS)

    Time frame: Baseline to 12 weeks

    Pain intensity is assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). The outcome measure is the change in VAS score from baseline to 12 weeks.

  2. Quality of Life Measured by Short Form-36 (SF-36)

    Time frame: Baseline to 12 weeks

    Quality of life is assessed using the Short Form-36 (SF-36), with scores ranging from 0 to 100. Higher scores indicate better health status. The outcome measure is the change in SF-36 score from baseline to 12 weeks.

Sponsors and collaborators

Lead sponsor

Tra Vinh General Hospital

Other

Registry information

Official study title

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

Acronym: AQUA-SPINE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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