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

1 de novembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Estimado)

90

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • Karabük Province
      • Karabük, Karabük Province, Turquia (Türkiye), 78000
        • Karabuk University
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 55 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

**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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.

Comparador Ativo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Motor Dual-Task Cost During the Timed Up and Go Test
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Cognitive Dual-Task Cost During the Timed Up and Go Test
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

10 de novembro de 2026

Conclusão Primária (Estimado)

1 de fevereiro de 2027

Conclusão do estudo (Estimado)

1 de julho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

19 de outubro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de outubro de 2026

Primeira postagem (Real)

26 de outubro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • KBU-DT-LBP-2026-01

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .