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临床试验/NCT07839052
NCT07839052尚未招募不适用

The Effect of Core Stabilization Exercises on Balance in Older Adults With Low Back Pain

University of West Attica1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年10月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Berg Balance Scale

研究概览

简要总结

This research aims to investigate the effect of a core stabilization exercise programme, combined with usual physiotherapy care, on balance in older adults, aged over 65 years with chronic non-specific low back pain. Participants will be randomly allocated to either an intervention group, receiving the core stabilization exercise programme additional to usual physiotherapy care, or a control group receiving usual physiotherapy care, combined with a general mobility and strengthening exercise programme. Participants will be assessed at baseline, after 12 weeks (3 months), and at a 6-month follow-up.

详细描述

This study will investigate the effect of a progressive core stabilisation programme combined with usual physiotherapy care on balance in older adults with chronic non-specific low back pain. Participants will be randomly allocated to one of two groups.

The intervention group will receive a core stabilisation programme in combination with usual physiotherapy care. The exercise programme will focus on activation, motor control and strength of trunk muscles, and the exercises will be performed in supine, prone, quadruped, sitting, and standing positions.

The control group will receive usual physiotherapy care and an additional general exercise programme, that will include mobility, strengthening, stretching and low-to-moderate walking exercises.

Participants will undergo assessments at three points. Specifically at baseline (T0), after completion of the 12 week intervention (T1), and at 6 months after the completion of intervention (T2). The assessments will be performed by an independent assessor, blinded to group allocation, in order to minimize assessment bias.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •65 years old or older. They have to be diagnosed with chronic non-specific low back pain lasting for at least 3 months.
  • •Low back pain intensity greater than 3/10 on the Visual Analog Scale (VAS). Functional independence. They have to be able to walk independently without assistive devices. Adequate cognitive function and ability to understand and follow instructions. Ability and willingness to provide written consent.

排除标准

  • •Severe spinal disorders, including spinal stenosis with neurological deficits, recent vertebral fracture or spondylolisthesis.
  • •Spinal surgery within the last 12 months. Acute low back pain, lasting less than 6 weeks. Neurological disorders affecting balance or postural control, including Parkinson's disease or stroke.
  • •Vestibular disorders that may significantly affect balance. Severe visual impairment or diagnosed cognitive impairment. Malignancy. Musculoskeletal or cardiopulmonary conditions at a level that affects and contraindicates exercise.
  • •If they use regurarly hig-dose analgesic medication, specifically for the management of the symptoms of low back pain.

研究组 & 干预措施

Core stabilisation exercises + usual physiotherapy care group

Experimental

Participants will receive a progressive core stabilization exercise programme combined with usual physiotherapy care. The intervention will be delivered twice per week for 12 weeks. Each intervention session will last approximately one hour.

干预措施: Core stabilisation exercises + usual physiotherapy care (Other)

Usual Physiotherapy care + General exercise programme group

Active Comparator

Participants will receive a general exercise programme combined with usual physiotherapy care. The intervention will be delivered twice per week for 12 weeks. Each intervention session will last approximately one hour.

干预措施: Usual physiotherapy care + general exercise programme (Other)

结局指标

主要结局

Berg Balance Scale

时间窗: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)

The Berg Balance Scale (BBS) is a 14-item standardized clinical assessment tool used to evaluate functional balance in older adults. It assesses static and dynamic balance during functional activities, including transfers, standing balance, turning, and single-leg stance. Each item is scored from 0 to 4, with a higher total score indicating better balance performance.

次要结局

  • Timed Up and Go(Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2))
  • Single Leg Stance test(Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2))
  • Sit to Stand test(Baseline (T0), 12 weeks (T1), additional assessment at 6 months (T2))
  • Oswestry Disability Index(Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2))
  • SF-36 Health Survey(Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2))
  • Stabilizer Pressure Biofeedback(Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Koutsampela Eva

PhD Canditate

University of West Attica

研究点 (1)

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