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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：EVA KOUTSAMPELA, PhD Canditate
- 電話番号：+306984872699
- メール：ekoutsampela@uniwa.gr
研究場所
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Galatsi
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Athens、Galatsi、ギリシャ、11146
- KINAISTHISI Physiotherapy Clinic Address: Pandora 2, Galatsi, 11146, Greece
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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. |
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アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Berg Balance Scale
時間枠：Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
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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)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Timed Up and Go
時間枠：Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
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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)
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Single Leg Stance test
時間枠：Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
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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)
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Sit to Stand test
時間枠：Baseline (T0), 12 weeks (T1), additional assessment at 6 months (T2)
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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)
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Oswestry Disability Index
時間枠：Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
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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)
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SF-36 Health Survey
時間枠：Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
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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)
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Stabilizer Pressure Biofeedback
時間枠：Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
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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)
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 64954
医薬品およびデバイス情報、研究文書
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米国FDA規制機器製品の研究
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