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Идёт набор NCT07472881

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

Без фазы С лечением Menopause Perimenopause Obesity Overweight

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Multi-acupoint low-level laser therapy, Sham Laser irradiation, Diet and exercise guidance.
Кому может быть актуально
Состояния в реестре: Menopause, Perimenopause, Obesity, Overweight. Базовые параметры: 45 лет — 55 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
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Официальное название

Effects of a Multi-acupoint Laser Therapy Device on Body Shape and Body Composition in Obese Menopausal Women

Обзор

The purpose of this study is to integrate Traditional Chinese Medicine (TCM) theory and therapeutic methods with modern low-level laser stimulation on corresponding acupoints, applying this combined approach to the field of weight management in menopausal women. The trial aims to investigate whether lifestyle modifications in accordance with WHO guidelines (dietary control and exercise), combined with adjunctive low-level laser acupuncture, can enhance weight reduction and improve body composition more effectively than standard lifestyle interventions alone.

Подробное описание

\*Study Objective: Investigate the effects of multi-acupoint low-level laser therapy on body composition in obese menopausal women, combining traditional Chinese medicine theory with laser stimulation of specific acupoints, alongside lifestyle interventions including diet and exercise according to WHO guidelines.

\*Participants: Total: 40 women, aged 45-55 years BMI \> 24 kg/m² or waist-to-hip ratio \> 0.88 Recruited from the outpatient clinic Randomly assigned to either the laser acupuncture group or control group

\*Intervention: Experimental group: 12 sessions of laser acupuncture over 6 weeks Each session: 30 minutes, targeting 10 acupoints related to weight management Both groups: standardized diet and exercise guidance per WHO recommendations

\*Primary Endpoints: Body composition changes:Body fat mass, Body fat percentage, Skeletal muscle mass, Total body weight, Limb muscle mass, Waist-to-hip ratio

* Secondary Endpoints: Menopausal symptoms (Menopause Rating Scale, MRS), Satiety levels (Visual Analog Scale, VAS) * Assessments:

Conducted at baseline, mid-treatment, and post-treatment Safety and tolerability monitored throughout the study

\*Statistical Analysis: Software: SPSS Methods: Independent t-tests, paired t-tests, Chi-square tests, correlation, regression analyses Significance: p \< 0.05

Вмешательства

  • Устройство Multi-acupoint low-level laser therapy
    Low-level laser therapy, 780 nm wavelength, 30 minutes per session, 12 sessions over 6 weeks, targeting 10 acupoints: bilateral Shenshu (BL23), Sanyinjiao (SP6), Tianshu (ST25), Shuifen (CV9), Guanyuan (CV4), and Dàdài (GB26).
  • Устройство Sham Laser irradiation
    Sham laser treatment that mimics the appearance and procedure of active low-level laser therapy but does not emit therapeutic laser energy. Sessions are conducted twice weekly for 6 weeks (12 sessions total).
  • Поведенческое Diet and exercise guidance
    WHO guideline-based diet and exercise counseling; weekly 5-10 minute sessions including waist, hip, and body composition monitoring.

Первичные конечные точки

  • Change in body fat mass [Срок оценки: Baseline, Week 3, Week 4, and Week 6]
Вторичные конечные точки (7)
  • Change in body weight [Срок оценки: Baseline, Week 3, Week 4, and Week 6]
  • Change in menopausal symptoms (Menopause Rating Scale score) [Срок оценки: Baseline and Week 6]
  • Change in satiety level (Visual Analog Scale) [Срок оценки: Baseline and Week 6]
  • Menopausal constitution classification score [Срок оценки: Baseline]
  • Change in skeletal muscle mass [Срок оценки: Baseline, Week 3, Week 4, and Week 6]
  • Change in body fat percentage [Срок оценки: Baseline, Week 3, Week 4, and Week 6]
  • Change in waist-to-hip ratio [Срок оценки: Baseline, Week 3, Week 4, and Week 6]

Критерии участия

Критерии включения

  • Female participants aged 45 to 55 years
  • No cognitive impairment or major psychiatric disorder
  • Able to understand the study procedures and communicate with research staff
  • Body mass index (BMI) > 24 kg/m² OR waist-to-hip ratio > 0.88

Критерии исключения

  • Pregnant or possibly pregnant women
  • Diagnosed chronic diseases currently under active treatment, including hepatitis, chronic kidney disease, chronic gastrointestinal disease, cardiovascular disease, or cancer
  • Systemic diseases such as hyperthyroidism, hypothyroidism, compensated liver cirrhosis, or autoimmune disorders
  • Currently receiving weight control treatment, including bariatric surgery or weight-loss medications
  • History of epilepsy or seizure disorder
  • Coagulation disorders or current use of anticoagulant therapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Тайвань · 1 центр
  • Chang Gung Memorial Hospital, Keelung Medical Center — Keelung

Публикации

  • 衛生福利部國民健康署. 婦女更年期保健手冊 - 更年期不適症狀評估量表. (Taipei: 國民健康署). Year.
  • Gong Y-Y, Guo B-Z, et al. 更年期證型與自律神經相關性研究. 中醫藥雜誌. 2012;23(1). DOI: 10.6940/JCM.201206_23(1).01.
  • Comparing the Efficacy of a Dual-Frequency LLLT Device With a Sham Device as a Therapy for Adipose Tissue Loss. ClinicalTrials.gov Identifier: NCT03811093.
  • Croghan IT, Hurt RT, Schroeder DR, Fokken SC, Jensen MD, Clark MM, Ebbert JO. Low-level laser therapy for weight reduction: a randomized pilot study. Lasers Med Sci. 2020 Apr;35(3):663-675. doi: 10.1007/s10103-019-02867-5. Epub 2019 Aug 31. PMID 31473867
  • Heinemann LA, Potthoff P, Schneider HP. International versions of the Menopause Rating Scale (MRS). Health Qual Life Outcomes. 2003 Jul 30;1:28. doi: 10.1186/1477-7525-1-28. PMID 12914663
  • El-Mekawy HS, ElDeeb AM, Ghareib HO. Effect of laser acupuncture combined with a diet-exercise intervention on metabolic syndrome in post-menopausal women. J Adv Res. 2015 Sep;6(5):757-63. doi: 10.1016/j.jare.2014.08.002. Epub 2014 Aug 19. PMID 26425364
  • Kamal WM, Maged AM, AbdelAziz S, Mahmoud SI, Mohsen RA. The effects of laser acupuncture on metabolic syndrome in obese postmenopausal women: a randomized controlled study. Lasers Med Sci. 2024 Aug 14;39(1):215. doi: 10.1007/s10103-024-04158-0. PMID 39138739

Идентификаторы

NCT: NCT07472881 · 202501462A3

Первоисточники (государственные реестры)

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