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Идёт набор NCT07152509

The Effect of Body Weight on Physical Activity Level, Functional Capacity, Balance, and Quality of Life in Individuals With Type 2 Diabetes Mellitus

— Наблюдательное Type 2 Diabetes Mellitus (T2DM) Body Mass Index Functional Capacity Balance

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: Observational Assessment.
Кому может быть актуально
Состояния в реестре: Type 2 Diabetes Mellitus (T2DM), Body Mass Index, Functional Capacity, Balance. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Обзор

This study aims to investigate the effects of body weight on physical activity level, functional capacity, balance, and quality of life in patients with type 2 diabetes mellitus (T2DM). A total of 50 volunteer patients who meet the inclusion criteria will be recruited from the Internal Medicine and Nutrition outpatient clinics of Bezmialem Vakıf University Hospital. Participants will be prospectively evaluated through face-to-face interviews. Assessments will include body composition analysis (Omron Body Composition Monitor), waist-to-hip ratio, lower extremity muscle strength (Muscle Hand-Held Dynamometer), grip strength (Hand Grip Dynamometer), physical activity level (International Physical Activity Questionnaire-Short Form), functional capacity (6-Minute Walk Test), balance (Biodex Balance System), clinical balance (Berg Balance Scale), and quality of life (Nottingham Health Profile). All statistical analyses will be performed using IBM SPSS Statistics 20. With this study, we aim to comprehensively evaluate multiple parameters in individuals with T2DM and investigate their interrelationships, thereby contributing to the current body of knowledge in the literature.

Вмешательства

  • Другое Observational Assessment
    The demographic, clinical, and personal characteristics of the individuals will be collected and recorded through a questionnaire. For all participants, body fat percentage (%), skeletal muscle mass percentage (%), visceral fat percentage (%), and resting metabolic rate (kcal), measured using the Omron Body Composition Monitor, will be recorded. Waist and hip circumference will be measured with a tape measure; lower extremity muscle strength (M. Quadriceps) will be assessed with a muscle hand-he

Первичные конечные точки

  • Functional capacity [Срок оценки: At baseline (single assessment)]
  • Assessment of Quality of Life Using the Nottingham Health Profile [Срок оценки: At baseline (single assessment)]
Вторичные конечные точки (7)
  • Body Composition [Срок оценки: At baseline (single assessment)]
  • waist-to-hip ratio [Срок оценки: At baseline (single assessment)]
  • Lower Extremity Muscle Strength Assessment [Срок оценки: At baseline (single assessment)]
  • Handgrip Strength [Срок оценки: At baseline (single assessment)]
  • Physical Activity Assessment [Срок оценки: At baseline (single assessment)]
  • Assessment of Functional Balance [Срок оценки: At baseline (single assessment)]
  • Postural stability assessment [Срок оценки: At baseline (single assessment)]

Критерии участия

Критерии включения

  • Having a diagnosis of Type 2 Diabetes Mellitus for at least 1 year
  • Being between 18 and 65 years of age
  • Having an HbA1c value between 6.5% and 11% at the time of diagnosis
  • No cognitive or mental problems
  • Ability to walk independently
  • Willingness to participate in the study

Критерии исключения

  • Presence of uncontrolled cardiovascular and pulmonary disease
  • Presence of vertigo or various vestibular system disorders
  • Presence of severe neurological or respiratory disease
  • History of stroke or myocardial infarction
  • Presence of a major musculoskeletal problem
  • Presence of chronic renal failure
  • Presence of diabetic ulcer or neuropathy
  • Pregnancy
  • Presence of hemolytic or renal anemia
  • Presence of serious visual, hearing, or speech impairments leading to lack of cooperation

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Turkey (Türkiye) · 1 центр
  • Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Re — Istanbul

Публикации

  • Rejeski WJ, Lang W, Neiberg RH, Van Dorsten B, Foster GD, Maciejewski ML, Rubin R, Williamson DF; Look AHEAD Research Group. Correlates of health-related quality of life in overweight and obese adults with type 2 diabetes. Obesity (Silver Spring). 2006 May;14(5):870-83. doi: 10.1038/oby.2006.101. PMID 16855197
  • Awotidebe TO, Adedoyin RA, Yusuf AO, Mbada CE, Opiyo R, Maseko FC. Comparative functional exercise capacity of patients with type 2-diabetes and healthy controls: a case control study. Pan Afr Med J. 2014 Nov 7;19:257. doi: 10.11604/pamj.2014.19.257.4798. eCollection 2014. PMID 25852800

Идентификаторы

NCT: NCT07152509 · BezmialemUNV2025

Первоисточники (государственные реестры)

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