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Swimming-Based Rehabilitation for Recovery After Thoracolumbar Spinal Fusion (AQUA-SPINE)

12. maj 2026 opdateret af: Le Hoang Nha, Tra Vinh General Hospital

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

124

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Vietnam
    • Vinh Long
      • Vĩnh Long, Vinh Long, Vietnam, 890000
        • Tra Vinh General Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients undergoing thoracolumbar spinal fusion at Tra Vinh General Hospital, Vietnam, who meet eligibility criteria and are followed prospectively for postoperative rehabilitation outcomes.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Swimming Rehabilitation
Patients undergoing structured swimming-based rehabilitation initiated 6-8 weeks after thoracolumbar spinal fusion, performed three sessions per week for 12 weeks.
Adfærdsmæssigt: Swimming-Based Rehabilitation
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.
Adfærdsmæssigt: Standard Rehabilitation
Conventional land-based postoperative rehabilitation including ambulation training, core stabilization, and flexibility exercises with similar frequency and duration.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Oswestry Disability Index (ODI)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Intensity Measured by Visual Analog Scale (VAS)
Tidsramme: 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
Quality of Life Measured by Short Form-36 (SF-36)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tra Vinh General Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2025

Primær færdiggørelse (Faktiske)

31. december 2025

Studieafslutning (Faktiske)

31. december 2025

Datoer for studieregistrering

Først indsendt

12. maj 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TVGH-SWIM-2025

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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