Pilot Study On Pulsed Electromagnetic Field Therapy For Osteosarcopenia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Lower limb strength
研究概览
简要总结
This prospective, single-site, single arm pilot study aims to assess the efficacy of Pulsed Electromagnetic Field (PEMF) exposure in the reduction of the decline in muscle strength, function and bone mineral density (BMD) in osteosarcopenia.
详细描述
This prospective, single-site, single-arm pilot study aims to assess the efficacy of Pulsed Electromagnetic Field (PEMF) exposure in the reduction of the decline in muscle strength, function and bone mineral density (BMD) in osteo-sarcopenia. For this pilot study, we will recruit 80 participants aged 65 years old and greater with osteo-sarcopenia, to receive PEMF therapy, at 1.5mT, once a week for 10 min to alternate lower limb (10 mins each week) weekly for 16 weeks. Participants will be followed up at baseline, 4, 8 and 12 and 17 weeks. At each follow-up, falls risk will be assessed by Short Physical Performance Battery (SPPB), including 6-minute walk and 5 sit-to-stand tests, Falls Efficacy Scale International (FESI), 3min-NS (3 minute Nutritional Screening) and SARC-F (Strength, Assistance with Walking, Rise from Chair, Climb Stairs and Falls) questionnaires. Muscle strength (hand grip and leg extension) and calf diameter are measured. Blood tests, saliva tests, and DEXA scans will be done at baseline, immediately after first PEMF exposure and week 17 to determine changes in biomarkers for senescence, bone/fat/muscle composition and skeletal muscle mass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years old and above, which corresponds to the geriatric patient population seen at the Healthy Ageing clinics and wards
- •Diagnosed with primary osteopenia, including primary osteoporosis, by BMD measurements on DEXA scans
- •Diagnosed with sarcopenia by SARC-F
- •Willing and able to give written informed consent
排除标准
- •Presence of metallic implants, pacemakers or insulin pumps
- •Presence of rheumatological disease (such as osteoarthritis or rheumatoid arthritis)
- •Presence of secondary osteoporosis (such as hyperparathyroidism, steroid-induced osteoporosis)
- •Presence of end-stage organ failure, including severe dementia or cancer
- •Pregnant women
结局指标
主要结局
Lower limb strength
时间窗: 18 weeks
Lower limb strength measurement measured by dynamometer
Handgrip strength
时间窗: 18 weeks
Handgrip strength measurement measured by dynamometer
Short Physical Performance Battery (SPPB)
时间窗: 18 weeks
Validated assessment tool for balance and lower limb strength (Score from 0 to 12)
6 minute walk test (6MWT)
时间窗: 18 weeks
Distance walked in a time of 6 minutes (units of meters)
次要结局
- Lean muscle and fat mass(18 weeks)
研究者
Louis Tee
Senior Resident
Alexandra Hospital