IMAT Quality in Aging
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Calf muscle strengthening.
- Кому может быть актуально
- Состояния в реестре: Aging. Базовые параметры: 65 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Targeting Intramuscular Adipose Quality in Aging
Обзор
This study will test the central hypothesis that fat within the muscle, or intramuscular adipose tissue (IMAT), exhibits elevated damage and pro-inflammatory signaling with aging, both of which are reduced by progressive resistance exercise (PRE). Sixteen older adults 65-80 years old will be recruited and complete a 12 week calf PRE intervention. Calf muscle strength, composition (measured by computed tomography) and muscle biopsies will be collected before and after the intervention. Histology, transcriptomic and secretomic tests will be completed to assess signs of damage and inflammation.
Подробное описание
Sixteen older adult (65-80 years) will be recruited from existing databases and screened for potential participation by phone. The Rapid Assessment of Physical Activity (RAPA) will be completed, to include those who are underactive (scores 3-5). Individuals who meet the inclusion criteria will attend an in-person screening where their calf muscle strength, physical performance and safety for muscle biopsy (via complete blood count with differential and prothrombin time/international normalized raio on blood draw) will be assessed. Individuals deemed safe to participate and who give informed consent will attend a second visit which will include a computed tomography (CT) scan of the lower leg and ultrasound-guided gastrocnemius muscle+IMAT biopsy. One week later, participants will begin the ankle plantarflexor-targeted progressive resistance exercise (PRE) program which will be delivered in a group Zoom format with a trained therapist 3 times per week for 12 weeks. One week following completion of the PRE program, participants will return for follow-up strength measures, CT, and biopsy. This will complete their participation. In the lab, biopsies will be subdivided for bulk ribonucleic acid sequencing (RNAseq), explant culture and histology. Bulk RNAseq will be used to identify age- and exercise-responsive genes that encode secreted proteins. These putative secreted signals will be validated by protein quantification in explant culture. The cellular origin of validated signals will then be mapped by RNA in situ hybridization (RNAscope) on the portion of the biopsy allocated to histology. Sections will also used to identify senescent cells, inflammatory macrophages and beige adipocytes.
Вмешательства
- Другое Calf muscle strengthening
The calf intervention will be delivered 3x/wk for 12 weeks over zoom, in small groups. There are 3 exercises 1) standing heel rise, 2) seated heel rise, and 3) long sitting ankle plantarflexion. The exercises will be overloaded using a weighted vest, body weight, and/or theraband. Exercises will be progressed as strength improves.
Первичные конечные точки
- Biopsy: Senescent cell density [Срок оценки: Baseline and post-intervention (approximately 14 weeks after baseline)]
Вторичные конечные точки (12)
- Total plantarflexor muscle volume (CT) (Cm^3) [Срок оценки: Baseline and post-intervention (approximately 14 weeks after baseline)]
- Plantarflexor Compartment Intramuscular Fat Volume (cm^3) [Срок оценки: Baseline and post-intervention (approximately 14 weeks after baseline)]
- Plantarflexor peak torque (Newton-meters) [Срок оценки: Baseline and post-intervention (approximately 14 weeks after baseline)]
- Stair Climb Power (W) [Срок оценки: Baseline and post-intervention (approximately 14 weeks after baseline)]
- Walking Speed (meters/second) [Срок оценки: Baseline and post-intervention (approximately 14 weeks after baseline)]
- Physical Performance Test Total Score [Срок оценки: Baseline and post-intervention (approximately 14 weeks after baseline)]
- Biopsy: Adipocyte size [Срок оценки: Baseline and post-intervention (approximately 14 weeks after baseline)]
- Biopsy: Macrophage density [Срок оценки: Baseline and post-intervention (approximately 14 weeks after baseline)]
- Biopsy: Beige adipocyte density [Срок оценки: Baseline and post-intervention (approximately 14 weeks after baseline)]
- Biopsy: Differentially expressed genes and pathways [Срок оценки: Baseline and post-intervention (approximately 14 weeks after baseline)]
- Biopsy: cytokine secretion [Срок оценки: Baseline and post-intervention (approximately 14 weeks after baseline)]
- Biopsy: Spatially resolved gene expression [Срок оценки: Baseline and post-intervention (approximately 14 weeks after baseline)]
Критерии участия
Критерии включения
- Rapid Assessment of Physical Activity scores between 3 and 5
- Able to don and doff the weighted vest
- Access to a smart phone and ability to navigate the phone to enter and manage a zoom intervention
- Commitment and availability to attend a virtual 40-minute intervention 3x per week for 12 weeks
Критерии исключения
- Contraindications to radiation exposure (e.g. Women who are pregnant, previous high radiation exposure)
- Bleeding disorders
- Lower extremity trauma/surgery/injury or neuropathy that would impact muscle structure and function or ability to complete exercise intervention
- Diabetes mellitus, cardiovascular disease, peripheral vascular disease, cancer, stage 4 hypertension, anemia, connective tissue disorder
- Neurological disorder (e.g. stroke, Parkinson's disease, multiple sclerosis, spinal cord injury)
- Medications: insulin, glucagon-like peptide-1 (GLP1) agonists, sex hormone replacement therapy, chronic NSAIDs, anticoagulation therapy, cholesterol lowering medications such as statins
- Unable to safely perform the progressive resistance exercise (e.g. Vestibular or balance issues that make performing the intervention unsafe, severe osteoporosis or general fragility that limits weighted vest tolerance)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Washington University — St Louis
Идентификаторы
NCT: NCT07506681 · 202512046 · 1R21AG091159-01A1