- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07618143
The Effects of Somatic-Based Chair Exercises in the Elderly
The Effects of Somatic-Based Chair Exercises on Balance, Pain, and Quality of Life in the Elderly
The primary aim of this study is to investigate the effects of easily applicable somatic-based chair exercises on balance and pain in the elderly. Additionally, the study aims to reveal the impact of exercise on functionality and cognitive level, and the resulting changes in quality of life.
The main research questions addressed in this study are:
- What are the most suitable exercise models that can be applied to improve pain control and balance in the elderly?
- How do the results of different approaches aimed at improving the quality of life in the elderly differ?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Somatic education refers to a process of sensory-motor learning that enables individuals to develop greater conscious control over their physiological functions. In this study, Thomas Hanna's definition of somatics and Hanna Somatic Education will be used. Thomas Hanna (1976) introduced the term "somatics" to describe the discipline of movement reeducation (somatic education/somatic movement), which aims to promote inner awareness of an individual's body. The practice of somatic movement involves pandiculation. Pandiculation is a process that starts with deliberate muscle activation and transitions into a slow and controlled eccentric release. This is done with ongoing sensory focus, and the movements remain gentle, unforced, and require little effort.
The study design involves comparing the effects of structured somatic-based chair exercises with the effects of a conventional exercise method consisting of basic range of motion exercises combined with static stretching.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: İlkay Tuğçe Köse, M.Sc.
- Número de teléfono: +90 444 5 438
- Correo electrónico: tugce_kose@gedik.edu.tr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 65 years of age or older
- To be volunteered to participate
- To be able to speak and understand Turkish at a good level
Exclusion Criteria:
- Scoring <24 on the Mini-Mental State Examination
- Any neurological or orthopedic problem that would prevent the implementation of assessment and exercise methods
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Somatic-based Chair Exercise Group
This group will participate in a structured somatic-based chair exercise program.
The program will last for 8 weeks, with sessions held twice a week, each lasting 35 to 40 minutes.
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The intervention includes a structured somatic-based chair exercise program (SSCE) developed in accordance with Thomas Hanna's somatic education approach.
The program consists of gentle, slow, and controlled movements incorporating pandiculation techniques to improve body awareness and movement control.
Exercises target multiple body regions, including the neck, trunk, pelvis, shoulders, upper and lower extremities, wrists, hips, and ankles.
Sessions will be performed twice weekly for 8 weeks, with each session lasting approximately 35-40 minutes.
A total of 35 volunteers will be enrolled in the SSCE.
Otros nombres:
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Comparador activo: Conventional Exercise Group
The conventional exercise group will participate in a program that combines static stretching and range of motion (ROM) exercises.
The exercise program will last for 8 weeks, with sessions held twice a week, each lasting 35 to 40 minutes.
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A total of 35 volunteers will be enrolled in the conventional exercise program, which combines range of motion (ROM) exercises and passive stretching of the same body regions and muscle groups as those addressed in the somatic exercise group.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain Assessment
Periodo de tiempo: 1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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Pain will be assessed via the Brief Pain Inventory (BPI).
BPI measures two objectives: the subjective severity of pain and the causal effect of pain.
The questions include numerical rating scales from 0 to 10 (0: none; 1-4: mild; 5-6: moderate, and 7-10: severe).
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1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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Balance Ability Assessment
Periodo de tiempo: 1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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Balance ability will be assessed by using the Berg Balance Test (BBT). The BBT measures balance ability (static and dynamic) among older adults. It is a qualitative measure that assesses balance by performing functional activities such as reaching, bending, transferring, and standing, including most components of postural control. The test contains 14 items. A higher score indicates better balance and a lower risk of falling. |
1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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Objective Balance Assessment via Becure Balance System
Periodo de tiempo: 1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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Objective balance performance will be assessed using the Becure Balance System.
The system utilizes the Nintendo WiiFit balance board integrated with computer-based software to evaluate static standing balance, center of gravity distribution, and postural oscillations.
The validity and reliability of the system have previously been established.
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1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cognitive Assessment
Periodo de tiempo: 1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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The Montreal Cognitive Assessment Scale (MoCA) will be used to assess changes in cognitive levels after the exercise program.
The scale is scored between 0 and 30, and includes 6 cognitive functions (memory, visual-spatial skills, executive functions, attention, concentration and working memory tasks, language, and orientation).
Higher scores indicate better cognitive performance.
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1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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Quality of Life Assessment
Periodo de tiempo: 1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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The Quality of Life Scale in the Elderly (CASP-19) will be used to determine changes in the volunteers' quality of life after the exercise program.
CASP-19 consists of 19 items and 4 sub-dimensions as 'Control', 'Autonomy', 'Enjoyment', and 'Self-actualization'.
Each item of the scale is rated on a 4-point Likert scale (0-3).
Higher scores indicate better perceived quality of life and well-being in older adults.
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1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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Assessment of Mobility
Periodo de tiempo: 1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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The Timed Up and Go test (TUG) will be used to assess mobility along with fall risk. TUG correlates well with balance, gait speed, and functional capacity. In this test, participants are instructed to stand up from a standard chair, walk 3 meters at a comfortable, safe pace, turn around, walk back to the chair, and sit down again. The total time required to complete the task is recorded in seconds. Shorter completion times indicate better functional mobility and dynamic balance, whereas longer times indicate poorer mobility and increased fall risk. |
1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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Upper Extremity Muscle Strength Assessment
Periodo de tiempo: 1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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The Weight Lifting Test (Arm Curl Test) will be used to assess upper extremity muscle strength. Participants perform as many arm curls as possible within 30 seconds while holding a standardized weight [5 lbs (2.3 kg) for women and 8 lbs (3.6 kg) for men]. Higher repetition counts indicate better upper extremity muscle strength. |
1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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Upper Extremity Flexibility Assessment
Periodo de tiempo: 1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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Upper extremity flexibility will be assessed using the Back Scratch Test (Apley Scratch Test).
The test measures the distance between or the overlap of the middle fingers behind the back.
An overlap between the fingers is recorded as a positive value, whereas a gap between the fingers is recorded as a negative value.
Higher positive values indicate better upper extremity flexibility.
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1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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Lower Extremity Muscle Strength Assessment
Periodo de tiempo: 1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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Lower extremity muscle strength will be assessed using the 30-Second Sit-to-Stand Test.
Participants perform as many sit-to-stand repetitions as possible within 30 seconds.
Higher repetition counts indicate better lower extremity muscle strength.
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1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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Lower Extremity Flexibility Assessment
Periodo de tiempo: 1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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Lower extremity flexibility will be assessed using the Chair Sit-and-Reach Test.
The test measures the distance between the fingertips and toes while reaching toward the foot from a seated position.
The distance between the fingertips and the toes is measured in centimeters.
Reaching beyond the toes is recorded as a positive value, whereas the inability to reach the toes is recorded as a negative value.
Higher positive values indicate better lower extremity flexibility.
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1 week before the study (T0); at week 4 (T1) and at week 8 (T2)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Mini-Mental State Examination (MMSE)
Periodo de tiempo: 1 week before the study (T0)
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The Mini-Mental State Examination (MMSE) will be used to identify the volunteers to be included in the study, as volunteers scoring 24-point or higher on the MMSE will be included in the study. The MMSE is a 30-point questionnaire commonly used to evaluate cognitive function, including orientation, attention, memory, language, and visuospatial skills. Scores range from 0 to 30, with higher scores indicating better cognitive function. |
1 week before the study (T0)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Pınar Kaya Sarıbaş, Assoc. Prof., Medipol University
- Investigador principal: İlkay Tuğçe Köse, M.Sc., Istanbul Gedik University
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
Otros números de identificación del estudio
- IGUN-ITKOSE-001
Información sobre medicamentos y dispositivos, documentos del estudio
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