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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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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

研究の種類

介入

入学 (推定)

90

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Karabük Province
      • Karabük、Karabük Province、トルコ(Türkiye)、78000
        • Karabuk University
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~55年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

**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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Motor Dual-Task Cost During the Timed Up and Go Test
時間枠: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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Cognitive Dual-Task Cost During the Timed Up and Go Test
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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.

協力者と研究者

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年11月10日

一次修了 (推定)

2027年2月1日

研究の完了 (推定)

2027年7月1日

試験登録日

最初に提出

2026年10月19日

QC基準を満たした最初の提出物

2026年10月19日

最初の投稿 (実際)

2026年10月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月3日

QC基準を満たした最後の更新が送信されました

2026年11月1日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • KBU-DT-LBP-2026-01

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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米国FDA規制機器製品の研究

いいえ

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