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

24. září 2026 aktualizováno: Koutsampela Eva, University of West Attica

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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

60

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

    • Galatsi
      • Athens, Galatsi, Řecko, 11146
        • KINAISTHISI Physiotherapy Clinic Address: Pandora 2, Galatsi, 11146, Greece

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

65 let a starší (Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Core stabilisation exercises + usual physiotherapy care group

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.

The core stabilization exercise programme will include activation, motor control and strengthening exercises targeting the deep and superficial trunk muscles. The programme will consist of exercises such as abdominal drawing-in maneuver, camel-cat exercise, bird dog, dead bug, bridges, modified front and side planks. The intervention will be individually progressed according to functional capacity and exercise tolerance. The duration of the exercise programme per session will be approximately 20-25 minutes, additional to approximately 5 minutes of warm-up and 5 minutes of cool-down.

The usual physiotherapy care will include joint and soft-tissue mobilisation, myofascial release techniques, superficial heat, low-frequency TENS, postural education, ergonomic advice and advice relevant to the maintenance of physical activity. This component of the intervention will be the same for both groups.

Aktivní komparátor: Usual Physiotherapy care + General exercise programme group

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.

Participants will receive usual physiotherapy care including interventions commonly used for the management of chronic low back pain. These will include joint and soft-tissue mobilisation, myofascial release techniques, superficial heat, low-frequency TENS, postural education, ergonomic advice and advice regarding physical activity. This component of the intervention will be the same for both groups.

To ensure comparable overall treatment duration between groups, participants will perform approximately 20 minutes of general mobility and strengthening exercises for the spine and upper and lower limb, as well as stretching exercises, additional to moderate intensity walking exercises. This exercise programme will not include specific core stabilisation exercises or balance exercises.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Berg Balance Scale
Časové okno: 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.

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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Timed Up and Go
Časové okno: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)

The Timed Up and Go test is used to assess functional mobility and dynamic balance. The participant has the instruction to stand up from the chair, walk 3 meters, turn, return to the chair and sit down. The total time needed to complete the task is recorded.

Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
Single Leg Stance test
Časové okno: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)

The Single Leg Stance test is used to assess static postural balance. The duration of the participant's ability to maintain a single leg stance withoout external support wll be recorded.

Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
Sit to Stand test
Časové okno: Baseline (T0), 12 weeks (T1), additional assessment at 6 months (T2)

The Sit-to-Stand test will be used for the assessment of the functional lower limb strength and dynamic balance. Participants will perform a repeated sit to stand task. The time required to complete the task will be recorded.

Baseline (T0), 12 weeks (T1), additional assessment at 6 months (T2)
Oswestry Disability Index
Časové okno: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)

The Oswestry Disability Index is a subjective outcome measure used to assess functional disability associated with low back pain. The outcome is expressed as a percentage, with higher scores indicating greater disability.

Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
SF-36 Health Survey
Časové okno: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)

The SF-36 Health Survey is a subjective, patient-reported, measure of health, related to the quality of life, that includes multiple subscales of physical and mental health.

Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
Stabilizer Pressure Biofeedback
Časové okno: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)

Trunk stabilization performance will be assessed with a Stabilizer Pressure Biofeedback device. The procedure will include two standardized tests.

In the first test, the device will be positioned beneath the participant's abdomen in the prone position at an initial pressure of 70 mmHg. The participant will perform an abdominal drawing in maneuver, in purpose to reduce the pressure by 10 mmHg and to maintain this position for as long as possible.

In the second test, the device will be positioned beneath the lumbar spine in the supine position at an initial pressure of 40 mmHg. The participant will perform a posterior pelvic tilt, aiming to increase the pressure by 10 mmHg and to maintain this position for as long as possible.

For both test, the duration for which the participant is able to maintain the target peressure will be recorded.

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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

25. října 2026

Primární dokončení (Odhadovaný)

25. července 2029

Dokončení studie (Odhadovaný)

25. října 2029

Termíny zápisu do studia

První předloženo

18. září 2026

První předloženo, které splnilo kritéria kontroly kvality

18. září 2026

První zveřejněno (Aktuální)

24. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

24. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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