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Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain (DT-CSE)

1 novembre 2026 aggiornato da: Ahmet Tezce, Karabuk University

Effect of Adding Concurrent Cognitive Tasks to Core Stabilization Exercise on Dual-Task Performance, Pain, and Disability in Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial

This study will investigate whether adding cognitive tasks to core stabilization exercises improves the ability to perform physical and mental tasks simultaneously in adults with chronic nonspecific low back pain.

A total of 90 participants aged 18-55 years will be randomly assigned to one of two groups. Both groups will complete the same supervised core stabilization exercise program, consisting of 18 sessions over six weeks. In the dual-task group, participants will perform cognitive activities, such as mental arithmetic and memory tasks, while exercising. In the single-task group, participants will perform the same exercises without additional cognitive tasks.

The primary outcome will be motor dual-task cost during the Timed Up and Go test, which measures the change in functional mobility performance when a cognitive task is performed simultaneously. Secondary outcomes will include cognitive dual-task performance, walking speed, balance, pain intensity, disability, and fear of movement.

Assessments will be conducted before treatment, immediately after the intervention, and at the 12-week follow-up.

The study aims to determine whether combining cognitive and physical tasks during core stabilization training provides additional benefits compared with conventional core stabilization exercises alone.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Chronic nonspecific low back pain (CNSLBP) is associated with impaired trunk motor control, pain-related disability, and alterations in functional movement. Many daily activities require individuals to perform motor and cognitive tasks simultaneously. However, conventional core stabilization exercises are generally performed under single-task conditions, which may limit the transfer of acquired motor skills to daily activities requiring divided attention.

This prospective, single-center, parallel-group, assessor-blinded randomized controlled trial will investigate the additional effects of concurrent cognitive tasks during core stabilization training in adults with CNSLBP.

Ninety participants aged 18-55 years will be enrolled at the Department of Physical Medicine and Rehabilitation, Karabuk University Faculty of Medicine, Türkiye. Participants will be randomly assigned to two intervention groups in a 1:1 allocation ratio using age-stratified permuted block randomization with variable block sizes of four and six. The age strata will be 18-39 and 40-55 years.

Both groups will receive an identical six-week core stabilization program consisting of 18 supervised sessions, three sessions per week. Each session will last 40 minutes, including a five-minute warm-up, 30 minutes of core stabilization exercises, and a five-minute cool-down.

The exercise program will progress through three stages: muscle activation (weeks 1-2), static stabilization (weeks 3-4), and dynamic and functional stabilization (weeks 5-6).

In the experimental group, participants will perform progressively challenging cognitive tasks simultaneously with stabilization exercises. Cognitive activities will include backward counting, verbal fluency tasks, reverse spelling, and working-memory tasks. Participants will be instructed to distribute attention equally between the motor and cognitive tasks.

The active comparator group will perform the same exercise program without concurrent cognitive tasks.

The primary outcome will be motor dual-task cost during the Timed Up and Go test at the post-intervention assessment. Motor dual-task cost will be calculated as the percentage increase in test completion time under dual-task compared with single-task conditions.

Secondary outcomes will include cognitive dual-task cost, walking speed assessed

Tipo di studio

Interventistico

Iscrizione (Stimato)

90

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Karabük Province
      • Karabük, Karabük Province, Turchia (Türkiye), 78000
        • Karabuk University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 55 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

**Inclusion Criteria:**

  • Adults aged 18-55 years.
  • Low back pain located between the costal margin and the inferior gluteal folds for at least three months.
  • Chronic nonspecific low back pain without an identifiable specific pathoanatomical cause based on clinical evaluation and radiological assessment, when available.
  • Average low back pain intensity of at least 3 points on the 0-10 Numerical Rating Scale (NRS) during the previous week.
  • Ability to read, write, and perform simple arithmetic tasks.
  • Willingness to participate in the study and provision of written informed consent.

**Exclusion Criteria:**

  • Lumbar radiculopathy or neurological deficit.
  • History of spinal surgery, vertebral fracture, spinal tumor, spinal infection, or inflammatory spinal disease.
  • Grade 2 or higher spondylolisthesis.
  • Neurological or vestibular disorders affecting balance.
  • Cognitive impairment, defined as a score below 21 on the Turkish version of the Montreal Cognitive Assessment (MoCA).
  • Uncorrected visual or hearing impairment.
  • Physiotherapy or participation in a structured exercise program within the previous three months.
  • Pregnancy.
  • Changes in the dosage of centrally acting medications, including gabapentinoids, opioids, or sedatives, within the previous four weeks.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Dual-Task Core Stabilization Exercise

Participants in this group will perform a six-week supervised core stabilization exercise program combined with concurrent cognitive tasks. The intervention will consist of 18 sessions, three sessions per week, with each session lasting 40 minutes. The exercise program will progress through muscle activation, static stabilization, and dynamic functional stabilization stages. Cognitive tasks will include backward counting, verbal fluency, reverse spelling, and working-memory activities, with progressively increasing difficulty. Participants will be instructed to give equal attention to the motor and cognitive tasks.

Participants will receive 18 supervised individual sessions over six weeks (three sessions per week, 40 minutes per session). Each session includes a 5-minute warm-up, 30 minutes of core stabilization exercises, and a 5-minute cool-down. Exercises progress from deep trunk muscle activation (weeks 1-2) to static stabilization (weeks 3-4) and dynamic functional stabilization (weeks 5-6). Concurrent verbal cognitive tasks increase in difficulty and include backward counting, category naming, verbal fluency, reverse spelling, auditory working-memory tasks, and category switching. Participants are instructed to give equal attention to motor and cognitive tasks. The first session is dedicated to exercise instruction.

Comparatore attivo: Single-Task Core Stabilization Exercise

Participants in this group will receive the same six-week supervised core stabilization exercise program without concurrent cognitive tasks. The program will consist of 18 sessions, three sessions per week, lasting 40 minutes each. Exercise content, intensity, progression, session duration, and therapist supervision will be identical to the experimental group. The physiotherapist will provide only standard instructions regarding exercise performance, without additional cognitive or attention-demanding tasks.

Participants will receive 18 supervised individual sessions of core stabilization exercises over six weeks (three sessions per week, 40 minutes per session). The exercise program will be identical to that of the dual-task group, progressing through muscle activation, static stabilization, and dynamic functional stabilization stages. No concurrent cognitive tasks will be performed.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Motor Dual-Task Cost During the Timed Up and Go Test
Lasso di tempo: Baseline and post-intervention (approximately 6 weeks)

Motor dual-task cost will be calculated as [(dual-task TUG time - single-task TUG time) / single-task TUG time] × 100. TUG time will be measured in seconds. During the dual-task condition, participants will count backward by threes while performing the TUG test. Two trials per condition will be averaged. Higher percentages indicate greater deterioration in motor performance under dual-task conditions. The primary comparison will be the post-intervention value adjusted for baseline performance and age stratum.

Baseline and post-intervention (approximately 6 weeks)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cognitive Dual-Task Cost During the Timed Up and Go Test
Lasso di tempo: Baseline, post-intervention (approximately 6 weeks), and 12-week follow-up.

Cognitive performance will be assessed by counting backward by threes under seated single-task and walking dual-task conditions. The correct response rate will be calculated as correct responses per second. Cognitive dual-task cost (%) = [(single-task correct response rate - dual-task correct response rate) / single-task correct response rate] × 100. Higher values indicate greater cognitive performance deterioration.

Baseline, post-intervention (approximately 6 weeks), and 12-week follow-up.
Walking Speed During the 10-Meter Walk Test
Lasso di tempo: Baseline, post-intervention (approximately 6 weeks), and 12-week follow-up.

Walking speed will be assessed under single-task and cognitive dual-task conditions on a 14-meter walkway, with the central 10 meters timed. During the dual-task condition, participants will count backward by threes. Two trials per condition will be averaged. Walking speed will be expressed in meters per second (m/s), with higher values indicating faster walking.

Baseline, post-intervention (approximately 6 weeks), and 12-week follow-up.
Single-Leg Stance Test Performance
Lasso di tempo: Baseline, post-intervention (approximately 6 weeks), and 12-week follow-up.

Static balance will be assessed on the preferred leg with arms crossed over the chest under three conditions: eyes open, eyes open with serial subtraction by threes, and eyes closed. Each trial will be limited to 45 seconds. The better result of two trials will be recorded for each condition. Performance will be expressed in seconds, with longer duration indicating better balance.

Baseline, post-intervention (approximately 6 weeks), and 12-week follow-up.
Pain Intensity Measured by the Numerical Rating Scale
Lasso di tempo: Baseline, post-intervention (approximately 6 weeks), and 12-week follow-up.

Average low back pain intensity during the previous week will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. A reduction of at least 2 points or 30% will be considered clinically important.

Baseline, post-intervention (approximately 6 weeks), and 12-week follow-up.
Disability Measured by the Oswestry Disability Index
Lasso di tempo: Baseline, post-intervention (approximately 6 weeks), and 12-week follow-up.

Low back pain-related disability will be assessed using the validated Turkish version of the Oswestry Disability Index (ODI). Scores will be expressed as percentages from 0% (no disability) to 100% (maximum disability). Higher scores indicate greater disability.

Baseline, post-intervention (approximately 6 weeks), and 12-week follow-up.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

10 novembre 2026

Completamento primario (Stimato)

1 febbraio 2027

Completamento dello studio (Stimato)

1 luglio 2027

Date di iscrizione allo studio

Primo inviato

19 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 ottobre 2026

Primo Inserito (Effettivo)

26 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • KBU-DT-LBP-2026-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be made publicly available due to participant confidentiality and data protection considerations. Study results will be reported in aggregate form in scientific publications.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .