Comparison of External and Internal Focus of Attention in Virtual Reality-Based Exercise Training in Older Adults With Chronic Low Back Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Frailty Level
研究概览
简要总结
Chronic low back pain is highly prevalent among older adults and is associated with impaired balance, increased fall risk, frailty, depressive symptoms, and reduced functional capacity. Exercise-based rehabilitation is a cornerstone of management in this population, and emerging evidence suggests that attentional focus strategies may influence motor learning and functional outcomes. Virtual reality-based exercise interventions provide an interactive and engaging environment that may further enhance rehabilitation outcomes in older individuals.
The purpose of this randomized controlled trial is to compare the effects of external and internal focus of attention strategies applied during a virtual reality-based core stabilization exercise program on frailty, balance, fall risk, lower extremity functional strength, sarcopenia risk, and depression in older adults with chronic low back pain.
Participants will be randomly allocated to either an external focus or internal focus group. Both groups will receive the same virtual reality-based core stabilization exercise program, administered three times per week for six weeks under physiotherapist supervision in a safe clinical setting. The exercise content, session duration, exercise volume, and progression will be identical between groups; the only difference will be the verbal and visual instructions provided to direct participants' attentional focus.
Outcomes will be assessed at baseline and after the intervention period. Frailty will be evaluated using the Frailty Assessment Scale (FAS-TR), sarcopenia risk using the SARC-T questionnaire, balance and fall risk using the Biodex Balance System, functional lower extremity strength using the Five Times Sit-to-Stand Test, and depressive symptoms using the Beck Depression Inventory. This study aims to determine whether attentional focus strategies differentially influence clinical and functional outcomes in older adults with chronic low back pain undergoing virtual reality-based exercise training.
详细描述
This randomized controlled trial will be conducted to investigate the comparative effects of external and internal focus of attention strategies applied during virtual reality-based exercise training in older adults with chronic low back pain.
Study Population and Setting The study population will consist of older adults aged 65 years and above who present to the Physical Therapy and Rehabilitation Clinic of Kırşehir Ahi Evran University Hospital, Kırşehir, Türkiye, with a diagnosis of chronic low back pain lasting at least three months. Individuals included in the target population will be community-dwelling older adults who are able to walk independently, perform most activities of daily living without assistance, and have no acute medical conditions that would contraindicate participation in a virtual reality-based exercise program.
Chronic low back pain in older adults is closely associated with balance impairments, increased fall risk, reduced physical activity, frailty, and psychological consequences. Therefore, this population has been selected to examine the potential benefits of attentional focus strategies integrated into virtual reality-based rehabilitation.
Eligibility will be determined through an initial screening interview and baseline assessment conducted by a physiotherapist in accordance with the inclusion and exclusion criteria.
Randomization and Study Groups
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 (Investigator)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 65 years and older
- •Diagnosis of non-specific chronic low back pain lasting at least 3 months
- •Ability to stand and walk independently (use of assistive devices such as a cane or walker is permitted)
- •Ability to perform most activities of daily living independently
- •No severe visual, auditory, or vestibular impairments that would prevent participation in a virtual reality-based exercise program
- •Adequate cognitive function to understand and follow instructions (Mini-Mental -State Examination score ≥ 24 or clinical judgment)
- •Willingness to participate in the study and provision of written informed consent
排除标准
- •Presence of specific causes of low back pain (e.g., vertebral fracture, tumor, infection, inflammatory rheumatic diseases, advanced spinal stenosis, spondylolisthesis)
- •History of lumbar spine or lower extremity surgery within the past 6 months
- •Presence of severe neurological disorders (e.g., stroke, Parkinson's disease, multiple sclerosis) or severe peripheral neuropathy
- •Uncontrolled cardiovascular, respiratory, or metabolic diseases that may pose a risk during exercise participation
- •Any acute medical condition or musculoskeletal disorder that contraindicates participation in exercise training
研究组 & 干预措施
Group 1: External Focus of Attention Virtual Reality Exercise Group
Participants in this group will receive a structured virtual reality-based core stabilization exercise program accompanied by verbal and visual instructions designed to direct attention toward the effects of movement on the environment, task outcomes, and externally defined targets within the virtual environment.
干预措施: Traditional treatment program (Other)
Group 1: External Focus of Attention Virtual Reality Exercise Group
Participants in this group will receive a structured virtual reality-based core stabilization exercise program accompanied by verbal and visual instructions designed to direct attention toward the effects of movement on the environment, task outcomes, and externally defined targets within the virtual environment.
干预措施: External Focus of Attention Virtual Reality Exercise (Other)
Group 2: Internal Focus of Attention Virtual Reality Exercise Group
Participants in this group will receive the same structured virtual reality-based core stabilization exercise program, accompanied by verbal and visual instructions aimed at directing attention toward body segment positioning, trunk control, muscle activation, and internal components of movement.
干预措施: Traditional treatment program (Other)
Group 2: Internal Focus of Attention Virtual Reality Exercise Group
Participants in this group will receive the same structured virtual reality-based core stabilization exercise program, accompanied by verbal and visual instructions aimed at directing attention toward body segment positioning, trunk control, muscle activation, and internal components of movement.
干预措施: Internal Focus of Attention Virtual Reality Exercise (Other)
结局指标
主要结局
Frailty Level
时间窗: 6 week
Frailty will be assessed using the Frailty Assessment Screening Tool (FAST-TR). FAST-TR is a validated and reliable screening instrument designed to identify frailty risk in older adults and includes physical, functional, and psychosocial components. Higher scores indicate greater frailty risk.
Balance Performance
时间窗: 6 week
Static and dynamic balance performance will be objectively assessed using the Biodex Balance System. The Biodex Balance System is a valid and reliable device widely used to evaluate postural control in older adults. Static balance will be assessed using the Postural Stability Test, which measures overall, anterior-posterior, and medial-lateral stability indices. Dynamic balance will be evaluated using the Limits of Stability (LOS) test, which assesses the participant's ability to voluntarily control their center of gravity within their base of support..
Fall risk
时间窗: 6 week
Fall risk will be evaluated using the Fall Risk Test protocol of the Biodex Balance System. This test objectively quantifies the individual's risk of falling by measuring balance performance on an unstable platform under standardized conditions. The Biodex Fall Risk Index provides an overall score, with higher scores indicating greater fall risk.
次要结局
- Pain Intensity(6 week)
- Sarcopenia Risk(6 week)
- Functional Lower Extremity Strength and Performance(6 week)
- Depression Level(6 week)
研究者
Safak Kuzu
Assist. Prof.
Kirsehir Ahi Evran Universitesi