Efficacy on Walking Ability of Electroacupuncture Therapy in Elderly Patients with Sarcopenia

The Third Affiliated hospital of Zhejiang Chinese Medical University

Status: Enrolling

Conditions: Sarcopenia

Treatments: Device: electroacupuncture; Behavioral: Rehabilitation Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05431010

2022ZB186

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 60 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 60 years ≤ age ≤ 95 years, male or female;
2. Patients are able to walk and communicate independently, and can complete required rehabilitation training;
3. Patients meet the diagnostic criteria proposed by the Asian Working Group for Sarcopenia(AWGS);
4. Patients volunteer to participate in this study and sign the informed consent.

Exclusion criteria

1. Patients with serious primary diseases of heart, brain, liver, kidney and hematopoietic system;
2. Patients with severe mental illness, cognitive impairment, and disorientation;
3. Patients have trauma and unsuitable for sports;
4. Patients with electronic devices or metal objects implanted in the body;
5. Patients can't complete the required rehabilitation training;
6. Patients cannot receive EA treatment due to any reasons
7. Patients are participating in other drugs, acupuncture and massage trials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

electroacupuncture and rehabilitation training

Experimental group

Description:

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

Treatment:

Behavioral: Rehabilitation Training

Device: electroacupuncture

rehabilitation training only

Active Comparator group

Description:

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).

Treatment:

Behavioral: Rehabilitation Training