- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07596238
Swimming-Based Rehabilitation for Recovery After Thoracolumbar Spinal Fusion (AQUA-SPINE)
Structured Swimming-Based Rehabilitation Improves Functional Recovery After Thoracolumbar Spinal Fusion: A Prospective Comparative Observational Cohort Study
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Vinh Long
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Vĩnh Long, Vinh Long, Vietnam, 890000
- Tra Vinh General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Swimming Rehabilitation
Patients undergoing structured swimming-based rehabilitation initiated 6-8 weeks after thoracolumbar spinal fusion, performed three sessions per week for 12 weeks.
|
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
Patients undergoing standard land-based postoperative rehabilitation including ambulation training, core strengthening, and flexibility exercises.
|
Conventional land-based postoperative rehabilitation including ambulation training, core stabilization, and flexibility exercises with similar frequency and duration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline to 12 weeks
|
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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.
|
Baseline to 12 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Rainville J, Hartigan C, Martinez E, Limke J, Jouve C, Finno M. Exercise as a treatment for chronic low back pain. Spine J. 2004 Jan-Feb;4(1):106-15. doi: 10.1016/s1529-9430(03)00174-8.
- Waller B, Lambeck J, Daly D. Therapeutic aquatic exercise in the treatment of low back pain: a systematic review. Clin Rehabil. 2009 Jan;23(1):3-14. doi: 10.1177/0269215508097856.
- Mannion AF, Elfering A. Predictors of surgical outcome and their assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S93-108. doi: 10.1007/s00586-005-1045-9. Epub 2005 Dec 1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TVGH-SWIM-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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