- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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?
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: İlkay Tuğçe Köse, M.Sc.
- Telefonní číslo: +90 444 5 438
- E-mail: tugce_kose@gedik.edu.tr
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
Ostatní jména:
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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Pain Assessment
Časové okno: 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
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Cognitive Assessment
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The Mini-Mental State Examination (MMSE)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Pınar Kaya Sarıbaş, Assoc. Prof., Medipol University
- Vrchní vyšetřovatel: İlkay Tuğçe Köse, M.Sc., Istanbul Gedik University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- IGUN-ITKOSE-001
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