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临床试验/NCT06401733
NCT06401733已完成不适用

Metabolic, Inflammatory, Cognitive Risk Stratification, and Intensive Aerobic and Resistance Exercise Intervention for Middle-aged and Older Adults With Type 2 Diabetes Mellitus

National University of Singapore1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2023年7月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Change in Cognitive Function Based on Risk Stratification Score (RSS)

研究概览

简要总结

A 12-week Intensive Aerobic and Resistance Exercise Program (IAREP) intervention was implemented on high-risk and low-risk subjects with cognitive impairment in type 2 Diabetes Mellitus. The study aims to evaluate the effectiveness of IAREP on cognition, metabolic and inflammatory health, physical function, vascular health, and health practice behaviour in the Type 2 Diabetes Mellitus population (T2DM).

详细描述

Background and Significance: T2DM is a leading cause of morbidity and mortality among adults worldwide, with approximately 5 million diabetes-related deaths accounting for 12.8% of all-cause mortality in 2015. The prevalence of T2DM in Asia is on the rise, with an anticipated increase from 78 million in 2015 to 140 million by 2040. Asia, therefore, is emerging as the "diabetes epicentre" due to rapid economic development, urbanisation, and nutrition transition. T2DM is a complex disease with environmental and genetic contributions that cause many severe complications in middle-aged and older adults, including a higher susceptibility to mild cognitive impairment (MCI) and dementia. The prevalence of cognitive impairment in T2DM ranges from 21.8% to 67.5% worldwide in all adults. Our previous study developed a risk stratification score (RSS) to quickly screen the T2DM population for high-risk or low-risk cognitive impairment. Exercise intervention plays a crucial role inof T2DM the management . Aerobic exercise has multiple benefits to metabolic functions, including increasing cardiovascular fitness, improving skeletal muscle capillary density, and reducing body fat. Resistance training is considered a promising intervention for reversing the loss of muscle function and deterioration of muscle structure associated with ageing. Intervention strategies, such as the proposed combined aerobic and resistance training program, will provide a guideline to prescribe exercise dosage for individuals with T2DM who are at risk of cognitive impairment.

Methods: A mixed-methods study was conducted, comprising a quasi-experimental control trial followed by a process evaluation through focus group discussions. The study screened 150 subjects, and 58 were recruited. Participants were assigned to either the exercise intervention group or the non-exercise control group according to their availability. The intervention group received a 12-week Intensive Aerobic and Resistance Exercise Program (IAREP), while the control group received usual care from Jurong National University Polyclinics without participating in the IAREP exercise.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 40 to 85
  • Living in the community
  • Diagnosed with type 2 diabetes mellitus (T2DM)
  • Literate in English or Mandarin
  • Activities of daily living (ADL)-independent
  • Obtain at least a score of 5 in short physical performance battery (SPPB) test

排除标准

  • Severe cognitive (e.g., dementia) or psychiatric disorders (e.g., schizophrenia or severe depression)
  • Severe hearing or vision impairments
  • Terminally ill medical conditions (e.g., end stage cancer), severe cardiovascular, respiratory (e.g., respiratory failure), or orthopedic conditions (e.g., freeze shoulder)
  • Absolute contraindications to aerobic exercise and resistance training programs (e.g., recent myocardial infarction or electrocardiography changes, complete heart block, acute congestive heart failure, unstable angina, uncontrolled hypertension)
  • Pregnant or breastfeeding women
  • Uncomfortable with video-recording of intervention sessions

研究组 & 干预措施

Intervention Group

Experimental

12-week Intensive Aerobic and Resistance Exercise Program (IAREP) intervention group

干预措施: Intensive Aerobic and Resistance Exercise Program (IAREP) (Other)

Control Group

No Intervention

Subjects that receive their usual care in Jurong polyclinic.

结局指标

主要结局

Change in Cognitive Function Based on Risk Stratification Score (RSS)

时间窗: Baseline and 12 weeks

Pre- and post-intervention measurements were conducted to assess the Risk Stratification Score (RSS). RSS scores range from -3.4 to 6.8; higher scores represent worse outcomes.

Number of Participants With Change in Cognitive Function (Cognitive Impairment) Based on Vascular Dementia Battery (VDB)

时间窗: Baseline and 12 weeks

Pre- and post-intervention measurements were conducted to assess the number of participants with change in cognitive function (Cognitive Impairment). This outcome reports the count of participants with Cognitive Impairment (CI) in each group at both assessments. A decrease in this count from Pre to Post indicates improved group cognitive function; an increase indicates worsened function. CI was diagnosed per Vascular Dementia Battery (VDB) criteria as a score below the clinical cutoff in any of its seven domains: executive function (score range 0-18), attention (score range 0-60), language (score range 0-15), verbal memory (score range 0-110), visual memory (score range 0-117), visuoconstruction (score range 0-97), and visuomotor speed (score range 0-150), where a higher score means a better outcome.

Change in Cognitive Function Based on the Montreal Cognitive Assessment (MoCA)

时间窗: Baseline and 12 weeks

Pre- and post-intervention measurements were conducted to assess the Montreal Cognitive Assessment (MoCA). MoCA scores range from 0 to 30, with higher scores indicating better outcomes.

次要结局

  • Change in Short Physical Performance Battery (SPPB)(Baseline and 12 weeks)
  • Change in Metabolic Health(Baseline and 12 weeks)
  • Change in Inflammatory Condition(Baseline and 12 weeks)
  • Change in Sarcopenia Risk(Baseline and 12 weeks)
  • Change in Blood Pressure(Baseline and 12 weeks)
  • Change in Physical Activity: International Physical Activity Questionnaire - Short Form(Baseline and 12 weeks)
  • Change in Self-care of Diabetes Index (SCODI)(Baseline and 12 weeks)
  • Change in Self-related and Health Practice (SRAHP)(Baseline and 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vivien Xi WU, PhD

Assistant Professor

National University of Singapore

研究点 (1)

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