Comparison of the Effects of Basic Body Awareness Therapy in Individuals With Knee Osteoarthritis

Официальное название

Comparison of the Effects of Basic Body Awareness Therapy to Conventional Physiotherapy and Home Exercise Program in Individuals With Knee Osteoarthritis

Обзор

Osteoarthritis (OA) is a chronic, degenerative joint disease associated with aging and is recognized by the World Health Organization as a primary health condition. It is one of the leading causes of chronic disability worldwide. Structural changes occurring at the bone and joint margins in OA lead to a variety of symptoms and clinical findings associated with the deterioration of articular cartilage integrity. Clinical guidelines recommend a combination of exercise therapy tailored to individual needs, weight loss, and patient education prior to considering arthroplasty. However, achieving satisfactory long-term outcomes remains challenging, as patients are often unmotivated to adhere to training programs involving functional strength and mobility exercises unless they are supervised by a physiotherapist. Basic Body Awareness Therapy (BBAT) may serve as an alternative exercise method with a higher potential for sustained effects. BBAT is a movement-based therapy applied to daily life activities, focusing on body alignment and movement quality. Through the learning process of BBAT-by doing, reflecting, and transferring body awareness into everyday movements-it is hypothesized that patients gain self-efficacy and skills essential for maintaining independent and continuous exercise. BBAT is a body-mind therapeutic approach that emphasizes awareness of body sensations and movement patterns, aiming to restructure body awareness and motor control through individual experience. Increased attention to movement and bodily experiences enhances awareness of both physical and mental aspects. Through specific exercises, BBAT helps to reveal and improve the interaction and synergy between body and mind, thereby promoting postural stability, movement fluidity, and awareness of bodily reactions and internal resources. By encouraging reduced energy expenditure during daily activities and improving movement quality through self-exploration and experiential learning, BBAT contributes to improvements in postural imbalance, muscle tension, and bodily dysfunction. BBAT movements are simple, comfortable, balanced, and based on repeated experiential learning. Exercises are performed in various positions, including lying, sitting, standing, and walking. Physiotherapists guide patients using both physical and verbal cues to facilitate improved postural control, balance, and breathing during movement. Central sensitization may lead individuals with osteoarthritis to perceive normal bodily functions as painful, resulting in compensatory and dysfunctional movement strategies. It has been reported that mindfulness-based and body-mind therapies can reduce pain and symptoms while improving physical function in clinical management. Moreover, as emphasized in the recommendations of the Osteoarthritis Research Society International (OARSI), active patient involvement in health management is a core component of body-mind therapies such as BBAT. Despite these potential benefits, there is a limited number of studies investigating the effects of BBAT in individuals with osteoarthritis. Given that BBAT requires no equipment, can be practiced in any setting, promotes social engagement through group-based sessions, enhances relaxation and mind-body awareness, and reduces stress and anxiety, it may represent a favorable alternative exercise model. Additionally, BBAT may improve exercise adherence and contribute to reducing healthcare burden and associated costs. Comparing the effects of different therapeutic programs across multiple outcome parameters may help identify the most effective interventions for individuals with osteoarthritis, thereby improving clinical outcomes. In this context, the present study aims to compare the effects of Basic Body Awareness Therapy, applied in addition to conventional physiotherapy and a home exercise program, on pain, muscle strength, range of motion, balance, active joint position sense, functional outcomes, pressure pain threshold, kinesiophobia, and quality of life in individuals with knee osteoarthritis.

Подробное описание

This study is designed as a three-arm randomized controlled clinical trial to evaluate the effectiveness of Basic Body Awareness Therapy (BBAT) compared with conventional physiotherapy and a home exercise program in individuals with knee osteoarthritis. Eligible participants will be randomly allocated to one of three intervention groups: (1) BBAT plus home exercise, (2) conventional physiotherapy plus home exercise, or (3) home exercise only.

The intervention period will last six weeks, with a total program duration of eight weeks. BBAT and conventional physiotherapy interventions will be delivered twice weekly by licensed physiotherapists according to standardized treatment protocols. BBAT sessions will be conducted in group settings and will focus on body awareness, posture, breathing, and controlled movement patterns. Participants in all groups will follow the same structured home exercise program.

Outcome assessments will be conducted at baseline and after completion of the intervention period. Primary and secondary outcomes will include pain intensity, proprioception, functional status, balance, physical performance, muscle strength, joint range of motion, edema, fatigue, kinesiophobia, and quality of life. These outcomes will be evaluated using validated clinical assessment methods and patient-reported outcome measures.

The primary objective of this study is to compare the effects of BBAT, conventional physiotherapy, and home exercise on clinical and functional outcomes in individuals with knee osteoarthritis.

Вмешательства

• Другое BBAT plus home exercise programme
  The participants will undergo Basic Body Awareness Therapy (BBAT) for a total of 12 sessions, conducted as two non-consecutive sessions per week over a 6-week period. Each active exercise session will last between 30 and 45 minutes. The body awareness training will specifically focus on lower extremity exercises and will follow a progressive protocol. The program will commence with 5 exercises in the first week, adding one new exercise each week to reach a total of 10 BBAT exercises. Initially,
• Другое Conventional physiotherapy plus home exercise programme
  Before each treatment session, a hot pack (thermotherapy) will be applied to the knee, calf, and thigh muscles for 20 minutes, followed by therapeutic ultrasound administered to the periarticular knee region for 10 minutes in pulsed mode, with a frequency of 1.0 MHz, an intensity of \<1 W/cm², and a total dose of \<150 J/cm². Exercises and recommendations identical to those prescribed for the home exercise group will be explained to the patients, and they will be instructed to perform these exer
• Другое Home exercise programme
  Based on the guidelines published by the American College of Sports Medicine (ACSM), Osteoarthritis Research Society International (OARSI), American Academy of Orthopaedic Surgeons (AAOS), European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO), and the European Alliance of Associations for Rheumatology (EULAR), participants will be prescribed a total of 12 home-based exercises to be performed over 8 weeks, at least 3 days per week,

Первичные конечные точки

• Muscle Strength / Hand-held dinamometer - Lafayette Instrument®, Lafayette, IN [Срок оценки: 8 weeks]
• Balance - Fullerton Advanced Balance Scale (FAB-T) [Срок оценки: 8 weeks]
• Pain Severity - The Numerical Rating Scale (NRS) [Срок оценки: 8 weeks]
• Active Joint Position Sense (AJPS) [Срок оценки: 8 weeks]
• Knee Function (KOOS) [Срок оценки: 8 weeks]
• Physical Mobility - TUG Test [Срок оценки: 8 weeks]
• Pressure Pain Threshold (PPT)/ (JTECH Medical-Algometer Commander, USA) [Срок оценки: 8 weeks]
• The Pain Catastrophizing Scale (PCS) [Срок оценки: 8 weeks]
• Knee Function (LYSHOLM) [Срок оценки: 8 weeks]
• Knee Function (WOMAC) [Срок оценки: 8 weeks]

Вторичные конечные точки (8)

• Quality of Life / (World Health Organization Quality of Life Scale - Brief Form (WHOQOL-BREF) [Срок оценки: 8 weeks]
• Kinesiophobia - Tampa Scale for Kinesiophobia (TSK) [Срок оценки: 8 weeks]
• Aerobic and Physical Performance (Stair Climb Test) [Срок оценки: 8 weeks]
• Edema Assesment (Tape Measure) [Срок оценки: 8 weeks]
• Range of Motion (ROM) - (Universal Goniometer) [Срок оценки: 8 weeks]
• Fatique / Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [Срок оценки: 8 weeks]
• World Health Organization Quality of Life - Older Adults Module (WHOQOL-OLD) [Срок оценки: 8 weeks]
• Aerobic and Physical Performance (6-Minute Walk Test (6MWT)) [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• Diagnosis of Grade 2-3 knee osteoarthritis based on the Kellgren-Lawrence radiographic grading system.
• Aged between 40 and 74 years.
• Meeting the clinical classification criteria of the American College of Rheumatology (ACR).

Критерии исключения

• Current or previous history of malignancy.
• Pregnancy or lactation.
• History of prior surgical intervention involving the knee or hip joints.
• Presence of neurological disorders impacting the innervation of the hip or knee musculature.
• Presence of concomitant inflammatory or infectious pathologies localized to the hip or knee joints.
• Having undergone physical therapy or rehabilitation interventions within the preceding 6 months.
• Administration of intra-articular injections (PRP, GRP, stem cell or corticosteroids) within the last 6 months.
• Severe cognitive impairment or diagnosis of dementia.
• Participation in regular physical exercise or sports activities for a minimum of 3 days per week.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Hacettepe University/Faculty of Physical Therapy and Rehabilitation/ Orthopedic Rehabilita — Ankara

Публикации

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• Eser S, Saatli G, Eser E, Baydur H, Fidaner C. [The reliability and validity of the Turkish Version of the World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-Old)]. Turk Psikiyatri Derg. 2010 Spring;21(1):37-48. Turkish. PMID 20204903
• Power M, Quinn K, Schmidt S; WHOQOL-OLD Group. Development of the WHOQOL-old module. Qual Life Res. 2005 Dec;14(10):2197-214. doi: 10.1007/s11136-005-7380-9. PMID 16328900
• Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667. PMID 9626712
• Vlaeyen JW, Kole-Snijders AM, Rotteveel AM, Ruesink R, Heuts PH. The role of fear of movement/(re)injury in pain disability. J Occup Rehabil. 1995 Dec;5(4):235-52. doi: 10.1007/BF02109988. PMID 24234727
• Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramoglu M. Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan;13(1):28-33. doi: 10.1016/j.joca.2004.10.010. PMID 15639634
• Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40. PMID 3068365
• Celik D, Coskunsu D, Kilicoglu O. Translation and cultural adaptation of the Turkish Lysholm knee scale: ease of use, validity, and reliability. Clin Orthop Relat Res. 2013 Aug;471(8):2602-10. doi: 10.1007/s11999-013-3046-z. Epub 2013 May 11. PMID 23666590

Идентификаторы

NCT: NCT07395427 · HU-FTR-EED-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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