NCT07414017

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Feb 2026May 2026

First Submitted

Initial submission to the registry

February 6, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 23, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Expected
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 6, 2026

Last Update Submit

February 25, 2026

Conditions

Keywords

GeriartricsChronic low back pain.External focus of attentionInternal focus of attention

Outcome Measures

Primary Outcomes (3)

  • Frailty Level

    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.

    6 week

  • Balance Performance

    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..

    6 week

  • Fall risk

    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.

    6 week

Secondary Outcomes (4)

  • Pain Intensity

    6 week

  • Sarcopenia Risk

    6 week

  • Functional Lower Extremity Strength and Performance

    6 week

  • Depression Level

    6 week

Study Arms (2)

Group 1: External Focus of Attention Virtual Reality Exercise Group

EXPERIMENTAL

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.

Other: Traditional treatment programOther: External Focus of Attention Virtual Reality Exercise

Group 2: Internal Focus of Attention Virtual Reality Exercise Group

EXPERIMENTAL

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.

Other: Traditional treatment programOther: Internal Focus of Attention Virtual Reality Exercise

Interventions

The study will be conducted over a total of 6 weeks, with sessions held 3 days per week. Each session will last approximately 45-60 minutes. All participants will undergo a virtual reality-assisted core stabilization exercise program under the supervision of a physical therapist in a safe environment. The following basic core stabilization exercises will be performed in both groups: * Diaphragmatic breathing and abdominal bracing * Pelvic tilt (posterior/anterior) * Bridge exercise * Opposite arm-leg lift in quadrupedal position * Seated and standing trunk stabilization exercises * Dynamic balance and weight transfer exercises

Group 1: External Focus of Attention Virtual Reality Exercise GroupGroup 2: Internal 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.

Group 1: External 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.

Group 2: Internal Focus of Attention Virtual Reality Exercise Group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirşehir Ahi Evran Univercity

Center, Kirşehi̇r, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trials
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 17, 2026

Study Start

February 23, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 15, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations