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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    120
  • sponsor
    The Third Affiliated hospital of Zhejiang Chinese Medical University
Updated on 4 October 2022
balance training
timed up and go test

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.

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.

Details
Condition Sarcopenia
Treatment Electroacupuncture, Rehabilitation training
Clinical Study IdentifierNCT05431010
SponsorThe Third Affiliated hospital of Zhejiang Chinese Medical University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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