Efficacy on Walking Ability of Electroacupuncture Therapy in Elderly Patients With Sarcopenia：a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 6min walk test
研究概览
简要总结
Introduction: The efficacy of existing therapies for the treatment of sarcopenia is still not satisfactory. Therefore, this randomized controlled, assessor-blinded study was designed to investigate the efficacy and safety of electroacupuncture(EA) therapy in elderly patients with sarcopenia.
Methods and analysis: This randomized controlled trial will enroll 120 elderly patients with sarcopenia. Subjects will be randomly assigned in a 1:1 ratio to either EA combined with rehabilitation training group or rehabilitation training group through a central computerized randomization system. Primary outcome measure is lower limb mobility, including 6-minute walk test、timed get up and go test, and short physical performance battery. Secondary outcome measures include lower limb muscle mass and lower limb muscle strength. Outcome assessment will be conducted before the intervention, at 12 weeks after the intervention and at the end of the 12-week follow-up. Adverse reactions will be evaluated during the trial.
Conclusion: This research will provide evidence to clarify whether EA is effective and safe in the treatment of sarcopenia.
详细描述
Introduction
The efficacy of existing therapies for the treatment of sarcopenia is still not satisfactory. Therefore, this randomized controlled, assessor-blinded study was designed to investigate the efficacy and safety of electroacupuncture(EA) therapy in elderly patients with sarcopenia.
Methods and analysis: This randomized controlled trial will enroll 120 elderly patients with sarcopenia. The experimental group is EA combined with rehabilitation training group, while the control group is rehabilitation training group. Rehabilitation training is the more recognized treatment method for sarcopenia all over the world. Eligible subjects will be randomly assigned to two group in a 1:1 allocation ratio. All participants will undergo 12 weeks of treatments in two groups. This protocol is based on the standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) and the SPIRIT reporting guidelines. Primary outcome measure is lower limb mobility, including 6-minute walk test、timed get up and go test, and short physical performance battery. Secondary outcome measures include lower limb muscle mass and lower limb muscle strength, such as lower extremity skeletal muscle mass、appendicular skeletal muscle mass、calf circumference、knee flexion and extension strength and grip strength. Outcome assessment will be conducted before the intervention, at 12 weeks after the intervention and at the end of the 12-week follow-up. Adverse reactions will be evaluated during the trial.
Conclusion: This research will provide evidence to clarify whether EA is effective and safe in the treatment of sarcopenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 years ≤ age ≤ 95 years, male or female;
- •Patients are able to walk and communicate independently, and can complete required rehabilitation training;
- •Patients meet the diagnostic criteria proposed by the Asian Working Group for Sarcopenia(AWGS);
- •Patients volunteer to participate in this study and sign the informed consent.
排除标准
- •Patients with serious primary diseases of heart, brain, liver, kidney and hematopoietic system;
- •Patients with severe mental illness, cognitive impairment, and disorientation;
- •Patients have trauma and unsuitable for sports;
- •Patients with electronic devices or metal objects implanted in the body;
- •Patients can't complete the required rehabilitation training;
- •Patients cannot receive EA treatment due to any reasons
- •Patients are participating in other drugs, acupuncture and massage trials.
研究组 & 干预措施
electroacupuncture and rehabilitation training
Participants in this group will received electroacupuncture（EA） combined with Otago exercise program(OEP). Acupuncture will be executed with size 0.30×40mm needle. EA will be performed with electronic acupuncture instruments
干预措施: electroacupuncture (Device)
electroacupuncture and rehabilitation training
Participants in this group will received electroacupuncture（EA） combined with Otago exercise program(OEP). Acupuncture will be executed with size 0.30×40mm needle. EA will be performed with electronic acupuncture instruments
干预措施: Rehabilitation Training (Behavioral)
rehabilitation training only
The rehabilitation group will be only treated with the Otago exercise program(OEP). The Otago Exercise is a program developed by the research group of fall prevention in the elderly led by Campbell of Otago Medical University in the 1990s. It is a home exercise program aimed at strengthening lower extremity muscle, balance and preventing falls in the elderly. Otago Exercise combines resistance exercise, balance training and aerobic walking and is an exercise prescription for elderly patients with sarcopenia (details are as follows).
干预措施: Rehabilitation Training (Behavioral)
结局指标
主要结局
6min walk test
时间窗: 12 weeks
The 6-min walking test setup is a straight line of 20 meters on a flat floor, and a chair is placed at each end as a sign. The subjects walk back and forth between them. The pace of walking is determined according to their own physical fitness, and they walk as fast as possible. In this way, the maximum walking distance that an individual can reach within 6 minutes will be texted
time to get up and go(TGUG)
时间窗: 12 weeks
The TGUG test measures the time it takes for an individual to get up from a chair, complete a short 3 meters round-trip walk, and finally sit back in the chair.
short physical performance battery (SPPB)
时间窗: 12 weeks
SPPB is a comprehensive test instrument that includes a walking speed test, a sit-to-stand test, and a balance test. The Walking Speed Test measures the time to pass a distance of 4 meters at daily walking speed. Sit-to-stand test is to calculate the time to complete 5 consecutive sets of getting up-sit down. The balance test includes 3 parts: 10 seconds for standing on the left and right side of both feet; standing on half front and half rear feet and standing on front and rear feet
次要结局
- calf circumference(12 weeks)
- lower extremity skeletal muscle mass(12 weeks)
- knee flexion and extension strength(12 weeks)
- appendicular skeletal muscle mass(ASMM)(12 weeks)
- grip strength(12 weeks)
研究者
Wenzhe Wu
Attending Physician
The Third Affiliated hospital of Zhejiang Chinese Medical University