- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07568691
Comparing Whole-Body Vibration vs. Balance Board Exercise for Pain, Function, and Quality of Life in Obese Adults With Knee Osteoarthritis
28 de abril de 2026 actualizado por: Tirza Z Tamin, Indonesia University
Comparison of the Effectiveness of Balance Training Using Stochastic Resonance Therapy-Whole Body Vibration and Balanced Board in Obese Patients With Knee Osteoarthritis: A Randomized Controlled Trial
Background: Osteoarthritis (OA) is a joint disease commonly found in the knee.
Therapeutic exercise has been known as the most common therapy to treat OA, however, therapy only focuses on reducing symptoms, not on treatment of the disease which help reduce cost and improve long term quality of life.
Objective: This randomized controlled trial aim was to compare the effectiveness of Stochastic Resonance Therapy-Whole Body Vibration (SRT-WBV) vs. Balance Board (BB) training on knee pain, knee function and quality of life in obese patients with osteoarthritis.
Design: Randomized controlled trial.
Methods: Forty-four subjects diagnosed with Grade I-II Osteoarthritis Kellgren Lawrence and Grade I obesity were included, randomized to two treatment groups, the SRT-WBV (n=22) or BB (n=22) to complete a series of exercises over eight weeks.
Evaluation using the following clinical outcomes: Visual Analog Scale (VAS), Timed Up and Go test (TUG), Single leg stance (SLS) test, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Short Form 12 Health Survey Questions (SF-12).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
44
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Universitas Indonesia, Cipto Mangunkusumo General Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- 45-65 years old patient
- VAS score ranged from 4 - 6
- Diagnosed with knee OA KL Grade I - II based on American College of Rheumatology Classification
- Grade I obesity
- Understand Bahasa Indonesia
Exclusion Criteria:
- Used assistive devices or can't walk
- Diagnosed with other medical conditions or mentally unstable
- Diagnosed with advanced stage of osteoporosis
- Had history of knee surgery
- Were currently taking analgesic or anti-inflammatory medications
- Pregnant
- Unwilling to participate
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Stochastic Resonance Therapy-Whole Body Vibration
Subjects assigned to the SRT-WBV group were required to stand on the footboard of the SRT-WBV (SR Therapiesysteme GmbH & Co. Lifescience KG, Berlin) device with shoulder width stance, and knees bent at 30 degrees, facing forward.
The trim settings progressed from weak (45 seconds with 8 repetitions), to mild (55 seconds with 8 repetitions), average (60 seconds with 6 repetitions), and strong (60 seconds with 6 repetitions), with intensity increased at two-week intervals.
Each repetition was separated by a resting period that had the same duration as the trim settings (weak: 45 seconds, mild: 55 seconds, average and strong: 60 seconds).
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A total of 16 therapeutic exercise sessions were conducted during the intervention where 2 sessions were conducted every week, separated by at least one day.
Specifically, subjects assigned to either group, with each session began with standardized warm-up exercises lasting approximately 5-10 minutes, followed by specific therapeutic exercises such as SRT-WBV and Balance Board.
Otros nombres:
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Comparador activo: Balance Board
Subjects were required to stand on the balance board with knees bent at 30 degrees and both hands placed on the chest with eyes opened.
The balance board intervention used different durations as its intensity, such as 7.5 minutes, 10 minutes, 12.5 minutes, and 15 minutes continuously without resting period.
The intensity of exercise was progressively increased every 2 weeks until completion of the program.
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The balance board intervention used different durations as its intensity, such as 7.5 minutes, 10 minutes, 12.5 minutes, and 15 minutes continuously without resting period.
The intensity of exercise was progressively increased every 2 weeks until completion of the program.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Knee function (WOMAC Total Score)
Periodo de tiempo: 8 weeks
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Knee function was assessed using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) questionnaire where pain score, stiffness, and physical function were evaluated on a scale of 0-4, with higher scores indicating worse pain, stiffness, and functional limitations.
The questionnaire contains 24 items and the WOMAC Osteoarthritis Index scores were then derived from the sum of the scores for the three subscales It was administered at the beginning and completion of the intervention, as well as every 4 weeks during the intervention.
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8 weeks
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Timed Up and Go Test (Balance)
Periodo de tiempo: 8 weeks
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Balance and mobility will be assessed using the Timed Up and Go Test.
The time (in seconds) taken to stand up from a chair, walk 3 meters, turn, return, and sit down will be recorded.
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8 weeks
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Straight Leg Raise Test
Periodo de tiempo: 8 weeks
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Balance/flexibility will be assessed using the Straight Leg Raise test.
The maximum angle (in degrees) achieved during leg elevation will be recorded.
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8 weeks
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Knee Pain (VAS Score)
Periodo de tiempo: 8 weeks
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Knee pain will be measured using the Visual Analog Scale ranging from 0 to 10, with higher scores indicating greater pain.
Participants will rate their pain at rest while seated.
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8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quality of Life (SF-12 Score)
Periodo de tiempo: 8 weeks
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Quality of life will be assessed using the SF-12.
Scores will be calculated according to standard scoring procedures.
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8 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Tirza Z Tamin, MD, Indonesia University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de marzo de 2023
Finalización primaria (Actual)
30 de septiembre de 2023
Finalización del estudio (Actual)
15 de octubre de 2023
Fechas de registro del estudio
Enviado por primera vez
21 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de abril de 2026
Publicado por primera vez (Actual)
6 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades musculoesqueléticas
- Trastornos Nutricionales
- Artritis
- Enfermedades Articulares
- Enfermedades reumáticas
- Sobrenutrición
- Peso corporal
- Exceso de peso
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Obesidad
- Osteoartritis
- Artrosis, Rodilla
Otros números de identificación del estudio
- SRTKneeOsteoarthritis
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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