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Focus of AttentionNCT07414017

Comparison of Focus of Attention in Virtual Reality-Based Exercise Training in Older Adults With Low Back Pain

A study testing Traditional treatment program, External Focus of Attention Virtual Reality Exercise and Internal Focus of Attention Virtual Reality Exercise in people with Focus of Attention, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 80 years
Conditions the study is for
Focus of Attention
What is being tested?
Traditional treatment program, External Focus of Attention Virtual Reality Exercise and Internal Focus of Attention Virtual Reality Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
23 Feb 2026to 15 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Şafak KUZU, PhD contact

+905068490542

safak.yumusak@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Kirşehir Ahi Evran Univercity

    Center, Kirşehi̇r

    Şafak KUZU, 05068490542, safak.yumusak@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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

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.

Read more

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.

Read the detailed description

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

After completion of all baseline assessments, eligible participants will be randomly allocated into one of two intervention groups using a randomization procedure:

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.

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.

The exercise content, session duration, number of exercises, and progression principles will be identical between the two groups. The only difference between groups will be the attentional focus instructions provided during exercise performance.

Intervention Protocol The intervention will be conducted over a total period of six weeks, with sessions administered three times per week. Each exercise session will last approximately 45-60 minutes. All sessions will be supervised by a physiotherapist and performed in a safe clinical environment.

All participants will engage in a virtual reality-supported core stabilization exercise program targeting trunk control, postural stability, balance, and functional movement performance. Exercise intensity and difficulty will be progressively adjusted according to participants' performance and tolerance throughout the intervention period.

The only difference between groups will be the type of attentional focus instructions delivered during exercise performance:

External Focus Group: Participants will receive verbal and visual cues directing attention toward movement outcomes, environmental interaction, and task-related effects within the virtual environment. Instructions will emphasize the impact of movement on virtual targets or external objects.

Internal Focus Group: Participants will receive verbal and visual cues directing attention toward body segment positioning, trunk muscle activation, and movement mechanics. Instructions will emphasize awareness of internal bodily movements and muscular control.

Depressive symptoms will be assessed using the Beck Depression Inventory. This study aims to determine whether different attentional focus strategies applied during virtual reality-based exercise training result in differential effects on physical, functional, and psychological outcomes in older adults with chronic low back pain.

Being tested
Traditional treatment program, External Focus of Attention Virtual Reality Exercise, Internal Focus of Attention Virtual Reality Exercise
Keywords
Geriartrics, Chronic low back pain., External focus of attention, Internal focus of attention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Traditional treatment programOther

    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
  • External Focus of Attention Virtual Reality ExerciseOther

    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.

  • Internal Focus of Attention Virtual Reality ExerciseOther

    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.

Study groups in NCT07414017
Study groupRoleWhat they receive
Group 1: External Focus of Attention Virtual Reality Exercise GroupExperimentalParticipants 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.
Receives: Other: Traditional treatment program; Other: External Focus of Attention Virtual Reality Exercise
Group 2: Internal Focus of Attention Virtual Reality Exercise GroupExperimentalParticipants 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.
Receives: Other: Traditional treatment program; Other: Internal Focus of Attention Virtual Reality Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 week

  2. 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..

    Measured: 6 week

  3. 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.

    Measured: 6 week

Secondary outcomes (4)
  1. Pain Intensity

    Low back pain intensity will be evaluated using the Visual Analog Scale (VAS). Participants will rate their perceived pain intensity on a 10-cm horizontal line ranging from "no pain" to "worst imaginable pain." Higher scores indicate greater pain severity. Pain will be assessed to reflect pain experienced at rest and during daily activities.

    Measured: 6 week

  2. Sarcopenia Risk

    Sarcopenia risk will be assessed using the SARC-T questionnaire. The SARC-T is a practical and reliable screening tool used to identify sarcopenia risk in community-dwelling older adults. Higher scores indicate increased risk of sarcopenia.

    Measured: 6 week

  3. Functional Lower Extremity Strength and Performance

    Functional lower extremity strength and performance will be evaluated using the Five Times Sit-to-Stand Test (5xSTS). Participants will be instructed to stand up and sit down five times as quickly as possible from a standard-height chair without using their arms. Test duration will be recorded in seconds, with longer times indicating reduced functional performance and increased fall risk.

    Measured: 6 week

  4. Depression Level

    Depressive symptoms will be assessed using the Beck Depression Inventory (BDI). The BDI is a validated self-report questionnaire commonly used to evaluate depressive symptoms in older adults. Higher scores indicate greater levels of depression.

    Measured: 6 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start23 Feb 2026
  3. Primary completion1 May 2026 (estimated)
  4. Study completion15 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trials
Masking
Single blind
Who is masked
Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07414017
Sponsor's protocol ID
52066301980/
Status last verified
Feb 2026
First submitted
6 Feb 2026
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Traditional treatment program, External Focus of Attention Virtual Reality Exercise and Internal Focus of Attention Virtual Reality Exercise in people with Focus of Attention, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Şafak KUZU, PhD (+905068490542, safak.yumusak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frailty Level (time frame: 6 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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