NCT07596238

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

May 12, 2026

Last Update Submit

May 12, 2026

Conditions

Keywords

Aquatic exerciseSwimmingSpinal fusion rehabilitationOswestry Disability IndexVAS pain scoreQuality of lifePostoperative rehabilitationThoracolumbar spine

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to 12 weeks

Secondary Outcomes (2)

  • Pain Intensity Measured by Visual Analog Scale (VAS)

    Baseline to 12 weeks

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

    Baseline to 12 weeks

Study Arms (2)

Swimming Rehabilitation

Patients undergoing structured swimming-based rehabilitation initiated 6-8 weeks after thoracolumbar spinal fusion, performed three sessions per week for 12 weeks.

Behavioral: Swimming-Based Rehabilitation

Standard Rehabilitation

Patients undergoing standard land-based postoperative rehabilitation including ambulation training, core strengthening, and flexibility exercises.

Behavioral: Standard Rehabilitation

Interventions

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.

Swimming Rehabilitation

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

Standard Rehabilitation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tra Vinh General Hospital

Vĩnh Long, Vinh Long, 890000, Vietnam

Location

Related Publications (3)

  • 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.

    PMID: 19114433BACKGROUND
  • 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.

    PMID: 14749199BACKGROUND
  • 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.

    PMID: 16320033BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurosurgeon

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 19, 2026

Study Start

January 1, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations