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

Summary

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.

Conditions

• Sarcopenia

Interventions

DEVICE

electroacupuncture

Participants are required to be in the supine position. Routine disinfection first. Participants are then subjected to acupuncture and achieve deqi sensation at all acupuncture points. Four paired of acupuncture points (i.e. Biguan acupoints and Futu points; Yanglingquan acupoints and Zusanli acupoints, identical on both sides) are connected to the EA devices. EA parameter is set as sparse wave and frequency is 2Hz. The intensity of the EA is determined by the patients' tolerance. Needles will be left in place and each session of EA will last 30 minutes. Participants will undergo a total of 36 EA sessions, with the frequency of 3 sessions every week for 12 weeks.

BEHAVIORAL

Rehabilitation Training

The rehabilitation training group will be only treated with the Otago exercise program(OEP). Otago Exercise combines resistance exercise, balance training and aerobic walking and is an exercise prescription for elderly patients with sarcopenia. 1. Exercise: including warm-up exercise (5 minutes) + resistance exercise (20 minutes) + balance training (5 minutes). Training intensity: 30 minutes a day, 3 times a week, once every other day, 12 weeks of training period; resistance exercise gradually increases the load. 2. Walking program: Take a walk. Activity intensity: 30 minutes each time, 2 times a week, combined with exercise (walking during the interval between exercise sessions), 12 weeks of training period

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University

  lead OTHER

Principal Investigators

• Wenzhe Wu, Master · The Third Affiliated hospital of Zhejiang Chinese Medical University

• Ming Guo, Doctor · Xiyuan Hospital of China Academy of Chinese Medical Sciences

• Hantong Hu, Doctor · The Third Affiliated hospital of Zhejiang Chinese Medical University

• Hong Gao, Master · The Third Affiliated hospital of Zhejiang Chinese Medical University

• Jinkuo Pang, Bachelor · The Third Affiliated hospital of Zhejiang Chinese Medical University

• Yanfei Cao, Master · The Third Affiliated hospital of Zhejiang Chinese Medical University

• Yiting Zhang, Master · The Third Affiliated hospital of Zhejiang Chinese Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

95 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-02

Primary Completion

2025-12-31

Completion

2026-12-31

Countries

• China

Study Locations