NCT07797140

Brief Summary

Sarcopenia is defined by the European Working Group on Sarcopenia in Older People (EWGSOP) as "a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength, carrying a risk of adverse outcomes such as physical disability, fractures, falls, impaired quality of life, and death. Obesity is classified according to the Body Mass Index (BMI), which is calculated by dividing weight in kilograms by the square of height in meters. According to the World Health Organization and most current guidelines for Western societies, obesity is defined as a BMI ≥ 30 kg/m². Sarcopenic obesity was first defined by Baumgartner as the co-occurrence of sarcopenia and obesity, measured using DEXA (10). Sarcopenic obesity is defined as the co-occurrence of high adiposity and sarcopenia; a term originally coined to describe low skeletal muscle mass, strength, and physical function, initially diagnosed in the elderly but present across the entire age spectrum. Combining the effects of both sarcopenia and obesity, sarcopenic obesity has been found to be associated with lower quality of life and greater disability, morbidity, and mortality compared to obesity or sarcopenia alone. Acupuncture is derived from the Latin words for needle (acus) and piercing (punctura). In Western languages, it is written as acupuncture. In traditional Chinese medicine, it is believed that diseases are caused by disturbances in the flow of life energy (Qi) circulating in channels called meridians in the body. Acupuncture aims to correct this disrupted energy flow by inserting needles into specific points along the meridians in the body. Numerous studies have reported that acupuncture is widely used in the treatment of obesity. Current evidence-based reviews have shown that acupuncture is effective in treating obesity. It has been suggested that acupuncture is an effective treatment for simple obesity rather than a placebo effect. The literature contains many studies on acupuncture in the treatment of obesity. However, there are no studies on acupuncture in sarcopenic obesity. Our study aimed to determine the effect of acupuncture on sarcopenia and obesity in patients with sarcopenic obesity.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 21, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2026

Completed
Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

2.3 years

First QC Date

August 21, 2026

Last Update Submit

September 23, 2026

Conditions

Keywords

Sarcopenic Obesityacupunctureexercisesarcopeniaobesity

Outcome Measures

Primary Outcomes (3)

  • Appendicular skeletal muscle mass

    Body composition was assessed using a DEXA scanner (Lunar iDXA; GE Healthcare, 3030 Ohmeda Drive, Madison, WI 53718, USA). Participants' weight, muscle mass and lean mass values were recorded. ASM was calculated as the sum of the bone-free lean mass of the four limbs.

    baseline-Week 6-Week 12

  • weight

    The weight was measured with a standardized weight scale.

    baseline-week 6-week 12

  • body mass index

    BMI was calculated as weight in kilograms divided by height in meters squared (kg/m²).

    baseline-week 6-week 12

Secondary Outcomes (6)

  • hand grip strength

    baseline-week 6-week 12

  • waist circumference and hip circumference measurement

    baseline-week 6-week 12

  • Sit-Up and Stand-Up Test (from a Chair)

    baseline-week 6-week 12

  • Walking speed of 4 meters

    baseline-week 6-week 12

  • Sarcopenia Quality of Life Scale (SarQoL)

    baseline-week 6-week 12

  • +1 more secondary outcomes

Study Arms (2)

exercise+diet

ACTIVE COMPARATOR

This group will receive a total of 10 sessions per week, 2 days a week consisting of aerobic exercises, resistance exercises, posture and balance exercises, and breathing exercises, as well as a diet program targeting sarcopenic obesity.

Other: Diet and exercise

acupuncture+exercise+diet

ACTIVE COMPARATOR

The second group will receive acupuncture treatment in addition to diet and exercise. Acupuncture treatment will be administered twice a week for a total of 10 sessions, with each session lasting at least 20 minutes. The acupuncture points used in the treatment have been determined based on previous research and are as follows: body acupuncture points ST25, ST36, SP15, LI4, Ren12, Ren6, Ki3, GB34, SP3, SP6, Liv8, SJ-6, Du 20, Yin Tang, Tai Yin; ear acupuncture points are shenmen, large intestine, hunger, and mouth points.

Other: Acupuncture

Interventions

This group will receive a total of 10 sessions per week, 2 days a week consisting of aerobic exercises, resistance exercises, posture and balance exercises, and breathing exercises, as well as a diet program targeting sarcopenic obesity.

exercise+diet

The second group will receive acupuncture treatment in addition to diet and exercise. Acupuncture treatment will be applied twice a week for a total of 10 sessions, with each session lasting at least 20 minutes. The acupuncture points the investigators will use in the treatment have been determined based on previous research and are as follows: body acupuncture points ST25, ST36, SP15, LI4, Ren12, Ren6, Ki3, GB34, SP3, SP6, Liv8, SJ-6, Du 20, Yin Tang, Tai Yin; ear acupuncture points are shenmen, large intestine, hunger, and mouth points.

acupuncture+exercise+diet

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having the mental and physical capacity to adapt to the work process
  • Being between 18-75 years of age
  • Being able to ambulate independently or with support
  • Having a body mass index (BMI) ≥ 30 kg/m2

You may not qualify if:

  • Pregnancy
  • Infection
  • Pacemaker
  • Peripheral circulatory disorder
  • Known concomitant malignancy, end-stage organ failure
  • Known concomitant central nervous system and/or peripheral nervous system disease
  • History of genetic disease
  • Coagulopathy
  • Having received acupuncture within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivitySarcopeniaObesity

Interventions

DietExerciseAcupuncture Therapy

Condition Hierarchy (Ancestors)

BehaviorMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaComplementary TherapiesTherapeutics

Study Officials

  • Ayşe U Baykut, M.D

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study was planned as a single-center, prospective, randomized controlled trial. Patients diagnosed with sarcopenic obesity according to WHO, FNIH, and EWGSOP2 guidelines will be included in the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

August 21, 2026

First Posted

September 1, 2026

Study Start

April 30, 2024

Primary Completion

August 20, 2026

Study Completion

September 25, 2026

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

I haven't decided yet.

Locations