Periodization-Based Strength Exercise Training in İndividuals With Type 2 Diabetes (T2DM_NLP)
2026年6月17日 更新者：Neslihan Duruturk、Baskent University
A Comparison of the Effects of Different Periodization-Based Strength Training Programs in Individuals With Type 2 Diabetes Mellitus
This randomized controlled study aims to compare the effects of different periodization-based strength training approaches in individuals with type 2 diabetes mellitus.
Participants will be allocated to non-linear periodization, linear periodization, or control groups.
The intervention program will be conducted for 8 weeks and will evaluate exercise capacity, muscle strength, quality of life, body composition, and metabolic parameters.
研究概览
地位
招聘中
条件
详细说明
Type 2 diabetes mellitus is associated with reduced exercise capacity, decreased muscle strength, impaired quality of life, and metabolic dysfunction. Exercise training is recommended as an important component of diabetes management; however, the comparative effectiveness of different strength training periodization approaches remains unclear.
This randomized controlled trial aims to compare the effects of non-linear periodization and linear periodization strength training programs in individuals with type 2 diabetes mellitus. Participants will be randomized into three groups: a non-linear periodization training group, a linear periodization training group, and a control group receiving usual care.
The intervention will be conducted for 8 weeks, three times per week. Outcomes including exercise capacity, muscle strength, body composition, quality of life, and metabolic parameters will be evaluated before and after the intervention period.
研究类型
介入性
注册 (估计的)
48
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ayşegül Erkoç, PT
- 电话号码：+90 553-301-36-73
- 邮箱：erkcaysegl@gmail.com
学习地点
-
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Ankara
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Ankara、Ankara、土耳其（türkiye）、06790
- 招聘中
- Baskent University Hospital
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接触：
- Ayşegül Erkoç, PT
- 电话号码：+90 553-301-36-73
- 邮箱：erkcaysegl@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Adults aged between 18 to 65 years
- Diagnosis of Type 2 Diabetes Mellitus (T2DM)
- Not having participated in any structured exercise program within the last 6 months
- Willingness to participate in the study and provide written informed consent
Exclusion Criteria:
- Presence of nephropathy, retinopathy, or peripheral neuropathy
- Presence of neurological, cognitive, or orthopedic disorders that may affect outcome measurements
- Severe respiratory disease (Forced Expiratory Volume in the first second [FEV1] <35% or Forced Vital Capacity [FVC] <50%)
- Presence of ischemic heart disease or peripheral arterial disease
- History of any cardiovascular event within the last 6 months
- Current malignancy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Non-linear Periodization Group
Participants will receive non-linear periodization-based strength training three times per week for 8 weeks.
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Participants will perform supervised non-linear periodization-based strength training three times per week for 8 weeks.
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实验性的：Linear Periodization Group
Participants will receive linear periodization-based strength training three times per week for 8 weeks.
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Participants will perform supervised linear periodization-based strength training three times per week for 8 weeks.
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有源比较器：Control Group
Participants will receive usual care and no structured exercise intervention during the study period.
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Participants will receive usual care and no structured exercise intervention during the study period.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Exercise Capacity
大体时间：Baseline and after 8 week
|
Exercise capacity will be assessed using the 6-Minute Walk Test (6MWT)
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Baseline and after 8 week
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Peripheral Muscle Strength
大体时间：Baseline and after 8 weeks
|
Peripheral muscle strength will be assessed using handheld dynamometry for upper and lower extremity muscle groups and reported in Newton (N).
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Baseline and after 8 weeks
|
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Change in Hand Grip Strength
大体时间：Baseline and after 8 weeks
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Hand grip strength will be assessed using a hand dynamometer and reported in kilograms (kg).
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Baseline and after 8 weeks
|
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Change in Diabetes Quality of Life Questionnaire Score
大体时间：Baseline and after 8 weeks
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Change in the Turkish version of the Diabetes Quality of Life Questionnaire (DQOL) total score and subscale scores from baseline to 8 weeks will be evaluated.
The DQOL consists of 45 items assessing treatment satisfaction, psychological impact, concerns about future effects of diabetes, and social/vocational concerns.
Each item is scored on a 1-5 scale, and higher scores indicate better diabetes-related quality of life.
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Baseline and after 8 weeks
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Change in Body Fat Percentage
大体时间：Baseline and after 8 weeks
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Body fat percentage (%) will be assessed using bioelectrical impedance analysis (BIA).
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Baseline and after 8 weeks
|
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Change in Skeletal Muscle Mass
大体时间：Baseline and after 8 weeks
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Skeletal muscle mass (kg) will be assessed using bioelectrical impedance analysis (BIA).
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Baseline and after 8 weeks
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Change in Resting Metabolic Rate
大体时间：Baseline and after 8 weeks
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Resting metabolic rate (kcal/day) will be assessed using indirect calorimetry (COSMED Fitmate Pro, Rome, Italy).
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Baseline and after 8 weeks
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Change in Hemoglobin A1c (HbA1c)
大体时间：Baseline and after 8 weeks
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Glycemic control will be assessed by measuring glycated hemoglobin (HbA1c) levels (%).
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Baseline and after 8 weeks
|
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Change in Fasting Blood Glucose
大体时间：Baseline and after 8 weeks
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Glycemic control will be assessed by measuring fasting blood glucose levels (mg/dL).
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Baseline and after 8 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Neslihan Duruturk, PhD、Baskent University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月1日
初级完成 (估计的)
2026年11月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年6月6日
首先提交符合 QC 标准的
2026年6月17日
首次发布 (实际的)
2026年6月22日
研究记录更新
最后更新发布 (实际的)
2026年6月22日
上次提交的符合 QC 标准的更新
2026年6月17日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.