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

2026年11月1日 更新者: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.

研究概览

详细说明

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

研究类型

介入性

注册 (估计的)

90

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 55年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

**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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

有源比较器: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Motor Dual-Task Cost During the Timed Up and Go Test
大体时间: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)

次要结果测量

结果测量
措施说明
大体时间
Cognitive Dual-Task Cost During the Timed Up and Go Test
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月10日

初级完成 (估计的)

2027年2月1日

研究完成 (估计的)

2027年7月1日

研究注册日期

首次提交

2026年10月19日

首先提交符合 QC 标准的

2026年10月19日

首次发布 (实际的)

2026年10月26日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月1日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • KBU-DT-LBP-2026-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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