- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07839052
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: EVA KOUTSAMPELA, PhD Canditate
- Phone Number: +306984872699
- Email: ekoutsampela@uniwa.gr
Study Locations
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-
Galatsi
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Athens, Galatsi, Greece, 11146
- KINAISTHISI Physiotherapy Clinic Address: Pandora 2, Galatsi, 11146, Greece
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
|
Active Comparator: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg Balance Scale
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 64954
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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