- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07652086
Basic Body Awareness Therapy for Healthy Young Adults
An Investigation Into the Effects of Basic Body Awareness Therapy on Musculoskeletal Pain, Spinal Mobility, Balance and Flexibility
Background:
Musculoskeletal pain, impaired postural control, and reduced movement quality are increasingly observed among young adults, partly due to sedentary lifestyles and insufficient physical activity. Basic Body Awareness Therapy (BBAT) is a physiotherapy-based mind-body approach designed to enhance body awareness, movement quality, balance, and postural stability through controlled functional movements. Although BBAT has demonstrated beneficial effects in various clinical populations, evidence regarding its effectiveness in healthy young adults remains limited.
Objective:This study aims to investigate the effects of a 12-week BBAT program on balance, musculoskeletal pain, spinal mobility, and flexibility in healthy young adults.
Methods:This randomized controlled trial will be conducted at the Healthy Living Laboratory of the University of Health Sciences, Gülhane Faculty of Physiotherapy and Rehabilitation, between June 2026 and May 2027. Healthy individuals aged 18-40 years will be recruited through voluntary participation and social media announcements. Participants will be randomly assigned to either a BBAT intervention group or a control group. The intervention group will participate in supervised BBAT sessions once weekly for 12 weeks, with each session lasting 45-60 minutes, while the control group will receive no intervention. Eligible participants will be individuals aged 18-40 years who have not participated in structured body-awareness-based exercise programs, such as BBAT, yoga, or Pilates, within the previous six months and who are able to complete all assessment procedures independently. Individuals with neurological, vestibular, rheumatological, or severe orthopedic disorders, recent surgery or injury affecting the spine or lower extremities, pregnancy, acute infection, or medication use affecting balance will be excluded.
Spinal mobility and flexibility will be the primary outcome measure. Secondary outcomes will include musculoskeletal pain and balance. Assessments will be performed before and after the intervention period.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background:
Musculoskeletal pain, postural control impairments, and reduced movement quality are increasingly prevalent among young adults, partly due to sedentary lifestyles and low physical activity levels. Basic Body Awareness Therapy (BBAT) is a physiotherapy-based mind-body approach that aims to improve body awareness, postural stability, movement quality, and balance through controlled functional movements. Although BBAT has demonstrated beneficial effects in various clinical populations, evidence regarding its effectiveness in healthy young adults remains limited.
Objective:
This study aims to investigate the effects of a 12-week BBAT program on musculoskeletal pain, spinal mobility, balance, and flexibility in healthy young adults.
Methods:
This randomized controlled trial will be conducted at the Healthy Living Laboratory of the University of Health Sciences, Gülhane Faculty of Physiotherapy and Rehabilitation, between June 2026 and May 2027. Healthy individuals aged 18-40 years will be recruited through social media announcements and voluntary participation. Participants will be randomly allocated to either an intervention group or a control group.
The intervention group will participate in BBAT sessions once weekly for 12 weeks, with each session lasting 45-60 minutes. The control group will receive no intervention during the study period. Inclusion criteria include being 18-40 years old, not having participated in structured body-awareness-based programs (e.g., BBAT, yoga, or Pilates) within the previous six months, and being able to complete the assessment procedures independently. Individuals with neurological, vestibular, rheumatological, or severe orthopedic disorders, recent surgery or injury affecting the spine or lower extremities, pregnancy, acute infection, or medications affecting balance will be excluded.
Spinal mobility and flexibility will be the primary outcome measure. Secondary outcomes will include musculoskeletal pain and balance. Assessments will be performed before and after the intervention period.
Sample size estimation was conducted using G*Power 3.1 based on a medium effect size (f = 0.25), α = 0.05, power = 80%, two groups, and two measurement points. The minimum required sample size was calculated as 36 participants. Considering a potential dropout rate of 15-20%, at least 40 participants (20 per group) will be recruited.
Hypotheses:
Compared with the control group, participants receiving BBAT are expected to demonstrate significantly greater improvements in (1) spinal mobility , (2) flexibility , (3)musculoskeletal pain, and (4) balance outcomes.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age between 18 and 40 years.
- Ability to walk independently without assistive devices.
- No participation in structured body-awareness-based exercise programs (e.g., Basic Body Awareness Therapy, yoga, or Pilates) within the previous 6 months.
- Ability to understand study procedures and comply with assessment protocols.
- Willingness to participate and provision of written informed consent.
Exclusion Criteria:
- History of neurological, vestibular, rheumatologic, or severe orthopedic disorders that may affect movement, balance, or mobility.
- History of spinal or lower-extremity surgery or musculoskeletal injury within the previous 6 months.
- Severe musculoskeletal pain limiting participation in assessments or intervention sessions.
- Pregnancy.
- Current use of medications known to affect balance, postural control, or motor performance.
- Presence of acute infection or other acute medical conditions at the time of enrollment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Control
The control group will be assessed for spinal mobility, flexibility, musculoskeletal pain, and balance at baseline and following a 12-week follow-up period.
Participants in this group will not receive any intervention throughout the study.
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Experimental: Exercise
The intervention group will participate in supervised BBAT sessions once weekly for 12 weeks, with each session lasting 45-60 minutes. BBAT exercises include; Grounding Postural balance Co-ordination Breathing Flow Mental awareness |
Participants allocated to the intervention group will receive a 12-week Basic Body Awareness Therapy (BBAT) program. The intervention will be delivered once weekly on the same day and at the same time each week, with each session lasting approximately 45-60 minutes. The BBAT program will consist of structured exercises performed in supine, sitting, and standing positions, focusing on postural alignment, muscle activation and relaxation, breathing awareness, weight transfer, balance control, and movement quality. Individual and partner-based exercises will be used to enhance body awareness, postural stability, and coordinated movement patterns. All sessions will be supervised and conducted by a physiotherapist who has completed BBAT Level III training. Participants will be encouraged to perform the movements with attention to body awareness, balance, breathing, and movement efficiency throughout the intervention period. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Spinal mobility
Periodo de tiempo: Baseline and Week 12
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Spinal mobility will be assessed using the Spinal Mouse® system (Idiag AG, Fehraltorf, Switzerland).
Measurements will be obtained in neutral standing, maximal flexion, maximal extension, and maximal lateral flexion positions.
Two measurements will be recorded for each position, and the average value will be used for analysis.
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Baseline and Week 12
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Flexibility
Periodo de tiempo: Baseline and Week 12
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Flexibility of the lumbar region and lower extremities will be evaluated using the Sit-and-Reach Test.
Participants will perform three trials, and the best score (cm) will be recorded for analysis.
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Baseline and Week 12
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Musculoskeletal pain
Periodo de tiempo: Baseline and Week 12
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Musculoskeletal pain and discomfort will be assessed using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ).
The CMDQ evaluates the frequency, severity, and functional impact of discomfort in different body regions.
Total CMDQ scores will be used for analysis.
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Baseline and Week 12
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Balance
Periodo de tiempo: Baseline and Week 12
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Balance performance will be assessed using the HUR Balance® system.
Static and dynamic postural control parameters, including center-of-pressure sway and stability measures, will be recorded according to the standardized testing protocol.
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Baseline and Week 12
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SBUBBAT
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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