Clinical trial NCT05431010: Efficacy on Walking Ability of Electroacupuncture Therapy in Elderly Patients with Sarcopenia
Official title: Efficacy on Walking Ability of Electroacupuncture Therapy in Elderly Patients with Sarcopenia：a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Keywords: sarcopenia；electroacupuncture; geriatric
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 6min walk test
timeFrame: 12 weeks
measure: time to get up and go(TGUG)
timeFrame: 12 weeks
measure: short physical performance battery (SPPB)
timeFrame: 12 weeks
Secondary outcomes:
measure: lower extremity skeletal muscle mass
timeFrame: 12 weeks
measure: appendicular skeletal muscle mass(ASMM)
timeFrame: 12 weeks
measure: calf circumference
timeFrame: 12 weeks
measure: knee flexion and extension strength
timeFrame: 12 weeks
measure: grip strength
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Wenzhe Wu, Master
role: STUDY_DIRECTOR
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Ming Guo, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Hantong Hu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Hong Gao, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Jinkuo Pang, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Yanfei Cao, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Yiting Zhang, Master
role: PRINCIPAL_INVESTIGATOR
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