Spinal FusionAQUA-SPINENCT07596238
Swimming-Based Rehabilitation for Recovery After Thoracolumbar Spinal Fusion
An observational study of Spinal Fusion and Postoperative Recovery, run by Tra Vinh General Hospital at 1 site in Vietnam.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Fusion, Postoperative Recovery, Low Back Pain
- What is being tested?
- Swimming-Based Rehabilitation and Standard Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 124 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing thoracolumbar spinal fusion at Tra Vinh General Hospital, Vietnam, who meet eligibility criteria and are followed prospectively for postoperative rehabilitation outcomes.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Spinal Fusion, Postoperative Recovery, Low Back Pain, Rehabilitation
- Being tested
- Swimming-Based Rehabilitation, Standard Rehabilitation
- Keywords
- Aquatic exercise, Swimming, Spinal fusion rehabilitation, Oswestry Disability Index, VAS pain score, Quality of life, Postoperative rehabilitation, Thoracolumbar spine
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swimming-Based RehabilitationBehavioural
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 RehabilitationBehavioural
Conventional land-based postoperative rehabilitation including ambulation training, core stabilization, and flexibility exercises with similar frequency and duration.
| Study group | Role | What they receive |
|---|---|---|
| Swimming Rehabilitation | Patients undergoing structured swimming-based rehabilitation initiated 6-8 weeks after thoracolumbar spinal fusion, performed three sessions per week for 12 weeks. Receives: Behavioral: Swimming-Based Rehabilitation | |
| Standard Rehabilitation | Patients undergoing standard land-based postoperative rehabilitation including ambulation training, core strengthening, and flexibility exercises. Receives: Behavioral: Standard Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oswestry Disability Index (ODI)
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.
Measured: Baseline to 12 weeks
Secondary outcomes (2)
Pain Intensity Measured by Visual Analog Scale (VAS)
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.
Measured: Baseline to 12 weeks
Quality of Life Measured by Short Form-36 (SF-36)
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.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tra Vinh General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Hoang Nha, Tra Vinh General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596238
- Sponsor's protocol ID
- TVGH-SWIM-2025
- Acronym
- AQUA-SPINE
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies and patient confidentiality considerations. De-identified data may be available upon reasonable request to the corresponding author.
Publications
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.
PubMed 19114433Rainville 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.
PubMed 14749199Mannion 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.
PubMed 16320033
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Swimming-Based Rehabilitation Improves Functional Recovery After Thoracolumbar Spinal Fusion: A Prospective Comparative Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07596238
- Acronym / sponsor ID
- AQUA-SPINE / TVGH-SWIM-2025
- Conditions
- Spinal Fusion, Postoperative Recovery, Low Back Pain, Rehabilitation
- Keywords
- Aquatic exercise, Swimming, Spinal fusion rehabilitation, Oswestry Disability Index, VAS pain score, Quality of life, Postoperative rehabilitation, Thoracolumbar spine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Tra Vinh General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Swimming Rehabilitation | – | Behavioral: Swimming-Based RehabilitationPatients undergoing structured swimming-based rehabilitation initiated 6-8 weeks after thoracolumbar spinal fusion, performed three sessions per week for 12 weeks. |
| Standard Rehabilitation | – | Behavioral: Standard RehabilitationPatients undergoing standard land-based postoperative rehabilitation including ambulation training, core strengthening, and flexibility exercises. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing thoracolumbar spinal fusion at Tra Vinh General Hospital, Vietnam, who meet eligibility criteria and are followed prospectively for postoperative rehabilitation outcomes.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swimming-Based RehabilitationStructured 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. | Behavioural | Swimming Rehabilitation |
| Standard RehabilitationConventional land-based postoperative rehabilitation including ambulation training, core stabilization, and flexibility exercises with similar frequency and duration. | Behavioural | Standard Rehabilitation |
Primary outcome
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.
2 secondary outcomes
Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: Baseline to 12 weeks
Quality of Life Measured by Short Form-36 (SF-36)
Time frame: Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Background: PubMed 19114433Waller 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.
- Background: PubMed 14749199Rainville 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.
- Background: PubMed 16320033Mannion 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policies and patient confidentiality considerations. De-identified data may be available upon reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Fusion and Postoperative Recovery, run by Tra Vinh General Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oswestry Disability Index (ODI) (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07596238, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.