Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

24. september 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Aktiv komparator: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Berg Balance Scale
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Timed Up and Go
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

25. oktober 2026

Primær fullføring (Antatt)

25. juli 2029

Studiet fullført (Antatt)

25. oktober 2029

Datoer for studieregistrering

Først innsendt

18. september 2026

Først innsendt som oppfylte QC-kriteriene

18. september 2026

Først lagt ut (Faktiske)

24. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere