The Effect of Core Stabilization Exercises on Balance in Older Adults With Low Back Pain
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: EVA KOUTSAMPELA, PhD Canditate
- Numero di telefono: +306984872699
- Email: ekoutsampela@uniwa.gr
Luoghi di studio
-
-
Galatsi
-
Athens, Galatsi, Grecia, 11146
- KINAISTHISI Physiotherapy Clinic Address: Pandora 2, Galatsi, 11146, Greece
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Comparatore attivo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Berg Balance Scale
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Timed Up and Go
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 64954
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .