Type 2 Diabetes Mellitus and Downhill Aerobic Exercise Training
2026年7月7日 更新者：Meryem BEKTAŞ KARAKUŞ、Acibadem University
The Effect of Downhill Walking Training on Functional Capacity, Peripheral Muscle Strength, and Cardiovascular Responses in Individuals With Type 2 Diabetes Mellitus
The purpose of this study is to compare the effects of an 8-week supervised downhill walking training program, prescribed based on the 6-minute walk test, on functional capacity, peripheral muscle strength, and cardiovascular responses in individuals with type 2 diabetes mellitus, as compared to a level walking training program.
Participants who agree to take part in the study will be randomly assigned to either the downhill or the level-ground walking group. Both groups will undergo a 6-minute walk test (6MWT) at the beginning of the study, and participants will then undergo an 8-week walking training program-conducted twice a week on a treadmill under the supervision of a physical therapist-in which their walking speed is determined based on their average speed during the 6MWT and gradually increased, with the duration of the sessions also being extended.
Participants will do the following:
- They will participate in walking training sessions at a center twice a week for 8 weeks, under the supervision of a physical therapist.
- Once a week for 8 weeks, they will walk the same distance they walked with their supervisor that week as a homework assignment.
- They will come to the facility where they conducted their exercise sessions for evaluations at the beginning of the program and after the 8th week.
研究概览
地位
招聘中
研究类型
介入性
注册 (估计的)
34
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：Meryem Bektaş Karakuş
- 电话号码：+90216 500 41 95
- 邮箱：meryem.bektas@acibadem.edu.tr
学习地点
-
-
Maltepe
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Istanbul、Maltepe、土耳其（türkiye）
- 招聘中
- Bezmialem Vakıf University Dragos Hospital
-
接触：
- Yasin Baki Baydaş, M.D.
- 电话号码：+90216 251 65 65
- 邮箱：ybaydas@bezmialem.edu.tr
-
-
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:
- Have been diagnosed with Type 2 diabetes mellitus according to the American Diabetes Association (ADA) diagnostic criteria
- Be able to walk independently and be physically capable of walking on a treadmill
- Have no acute cardiovascular, neurological, or orthopedic conditions that would prevent participation in the exercise program
- No major changes to antidiabetic or cardiometabolic treatments within the last 3 months
- To be under regular follow-up and in a stable clinical condition
- To have been informed about the study and to provide written informed consent
Exclusion Criteria:
- Patients with severe peripheral neuropathy or a lack of protective sensation
- Lower extremity amputation
- Diabetic foot ulcer or the presence of severe skin lesions that impair walking
- Proliferative diabetic retinopathy or advanced retinopathy that could pose a risk of complications during exercise
- Severe diabetic nephropathy (eGFR <30 mL/min/1.73 m² or macroalbuminuria >300 mg/g)
- Uncontrolled hypertension (systolic blood pressure >200 mmHg and/or diastolic blood pressure >110 mmHg)
- Fasting blood glucose level >250 mg/dL with signs of ketosis
- Unstable angina pectoris, a history of myocardial infarction within the past 6 months, or a history of clinically significant severe arrhythmia
- Advanced heart failure (NYHA Class III-IV)
- Having a chronic respiratory disease
- Having participated in a regular exercise, sports, or physical therapy program within the past 6 months
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：Downhill Walking
|
This involves performing a progressive aerobic exercise program-prescribed based on the results of a 6-minute walk test-twice a week for 8 weeks, at a constant 10-degree downhill, under the supervision of a physical therapist.
It involves assigning the distance walked during that week's exercise session-conducted under the supervision of a physical therapist-as homework to be walked at home on one day of the same week.
|
|
有源比较器：Level Walking
|
It involves assigning the distance walked during that week's exercise session-conducted under the supervision of a physical therapist-as homework to be walked at home on one day of the same week.
This involves performing a progressive aerobic exercise program-prescribed based on the results of a 6-minute walk test-twice a week for 8 weeks, at a constant 0-degree (i.e., level) slope, under the supervision of a physical therapist.
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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 |
|---|---|---|
|
6-Minute Walk Test (6MWT)
大体时间：From baseline to the end of treatment at 8 weeks
|
The 6DYT is a walking test used to assess a participant's submaximal exercise capacity, during which the participant walks for six minutes at a self-determined pace.
The patient walks as far as possible along a 30-meter corridor for six minutes.
The total distance walked during the test will be recorded in meters as the primary outcome measure.
|
From baseline to the end of treatment at 8 weeks
|
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Measurement of Peripheral Muscle Strength
大体时间：From baseline to the end of treatment at 8 weeks
|
Muscle strength measurements for hip extension, knee extension, knee flexion, and ankle plantar flexion will be performed using a handheld dynamometer.
A dynamometer is a device that enables more quantitative measurements; the person conducting the test holds it in their hand to perform manual muscle testing.
Different body segments have different pads.
The muscles will be properly positioned and assessed.
For each muscle group, measurements will be performed 3 to 5 times on both the right and left extremities, and the peak force will be recorded for each muscle group.
Results will be recorded in Newtons.
|
From baseline to the end of treatment at 8 weeks
|
|
Heart Rate Variability (HRV) - Root Mean Square of Successive Differences (RMSSD)
大体时间：From baseline to the end of treatment at 8 weeks
|
Heart Rate Variability (HRV) analysis will be conducted to assess participants' autonomic nervous system responses and cardiovascular adaptability.
A high-precision Polar H10 (Polar Electro Oy, Kempele, Finland) heart rate chest strap will be used for data collection.
After participants rest for 5 minutes in a supine (on their back) position in a quiet environment, 5-minute short-term R-R interval recordings will be taken.
The collected data will be analyzed using the Kubios HRV (v1.7.13,
Kubios Oy, Kuopio, Finland) mobile app.
The software's automatic artifact correction algorithm will be used to remove signal noise.
The RMSSD values will be recorded in milliseconds (ms) as a key indicator of parasympathetic activity.
|
From baseline to the end of treatment at 8 weeks
|
|
Heart Rate Variability (HRV) - Standard Deviation of NN Intervals (SDNN)
大体时间：From baseline to the end of treatment at 8 weeks
|
Heart Rate Variability (HRV) analysis will be conducted to assess participants' autonomic nervous system responses and cardiovascular adaptability.
A high-precision Polar H10 (Polar Electro Oy, Kempele, Finland) heart rate chest strap will be used for data collection.
After participants rest for 5 minutes in a supine (on their back) position in a quiet environment, 5-minute short-term R-R interval recordings will be taken.
The collected data will be analyzed using the Kubios HRV (v1.7.13,
Kubios Oy, Kuopio, Finland) mobile app.
The software's automatic artifact correction algorithm will be used to remove signal noise.
The SDNN values will be recorded in milliseconds (ms) to reflect overall autonomic variability.
|
From baseline to the end of treatment at 8 weeks
|
|
Heart Rate Variability (HRV) - Mean RR Interval
大体时间：From baseline to the end of treatment at 8 weeks
|
Heart Rate Variability (HRV) analysis will be conducted to assess participants' autonomic nervous system responses and cardiovascular adaptability.
A high-precision Polar H10 (Polar Electro Oy, Kempele, Finland) heart rate chest strap will be used for data collection.
After participants rest for 5 minutes in a supine (on their back) position in a quiet environment, 5-minute short-term R-R interval recordings will be taken.
The collected data will be analyzed using the Kubios HRV (v1.7.13,
Kubios Oy, Kuopio, Finland) mobile app.
The software's automatic artifact correction algorithm will be used to remove signal noise.
The Mean RR values will be recorded in milliseconds (ms) to indicate the average time between heartbeats.
|
From baseline to the end of treatment at 8 weeks
|
|
Heart Rate Variability (HRV) - LF/HF Ratio
大体时间：From baseline to the end of treatment at 8 weeks
|
Heart Rate Variability (HRV) analysis will be conducted to assess participants' autonomic nervous system responses and cardiovascular adaptability.
A high-precision Polar H10 (Polar Electro Oy, Kempele, Finland) heart rate chest strap will be used for data collection.
After participants rest for 5 minutes in a supine (on their back) position in a quiet environment, 5-minute short-term R-R interval recordings will be taken.
The collected data will be analyzed using the Kubios HRV (v1.7.13,
Kubios Oy, Kuopio, Finland) mobile app.
The software's automatic artifact correction algorithm will be used to remove signal noise.
The LF/HF ratio will be recorded as a dimensionless value summarizing the sympathovagal balance.
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From baseline to the end of treatment at 8 weeks
|
|
Fatigue Severity Scale (FSS)
大体时间：From baseline to the end of treatment at 8 weeks
|
The Fatigue Severity Scale is a 9-item measure that assesses the severity of fatigue and how it affects a person's activities.
Participants respond to each item on a Likert scale ranging from 1: "I strongly disagree" to 7: "I strongly agree."
The total score on the scale ranges from a minimum of 9 to a maximum of 63.
Higher scores indicate more severe fatigue and greater impairment.
The use of this scale is recommended for assessing fatigue in patients with type 2 diabetes.
|
From baseline to the end of treatment at 8 weeks
|
|
Blood Test Results: Glycated Hemoglobin (HbA1c)
大体时间：From baseline to the end of treatment at 8 weeks
|
HbA1c levels will be measured to assess participants' long-term glycemic control and the metabolic effects of the exercise training.
The blood sample will be ordered by the attending physician and analyzed using standard laboratory methods.
Results will be reported as a percentage (%).
|
From baseline to the end of treatment at 8 weeks
|
|
Blood Test Results: Fasting Blood Glucose (FBG)
大体时间：From baseline to the end of treatment at 8 weeks
|
Fasting blood glucose levels will be measured to assess participants' current metabolic status.
The blood sample will be ordered by the attending physician after an overnight fast and analyzed using standard laboratory methods.
Results will be reported in milligrams per deciliter (mg/dL).
|
From baseline to the end of treatment at 8 weeks
|
|
Lipid Profile: Low-Density Lipoprotein (LDL) Cholesterol
大体时间：From baseline to the end of treatment at 8 weeks
|
LDL cholesterol levels will be measured for the purposes of cardiovascular risk management and monitoring metabolic adaptation.
The blood sample will be ordered by the attending physician and analyzed using standard laboratory methods.
Results will be reported in milligrams per deciliter (mg/dL).
|
From baseline to the end of treatment at 8 weeks
|
|
Lipid Profile: High-Density Lipoprotein (HDL) Cholesterol
大体时间：From baseline to the end of treatment at 8 weeks
|
HDL cholesterol levels will be measured for the purposes of cardiovascular risk management and monitoring metabolic adaptation.
The blood sample will be ordered by the attending physician and analyzed using standard laboratory methods.
Results will be reported in milligrams per deciliter (mg/dL).
|
From baseline to the end of treatment at 8 weeks
|
|
Lipid Profile: Triglycerides
大体时间：From baseline to the end of treatment at 8 weeks
|
Triglyceride levels will be measured for the purposes of cardiovascular risk management and monitoring metabolic adaptation.
The blood sample will be ordered by the attending physician and analyzed using standard laboratory methods.
Results will be reported in milligrams per deciliter (mg/dL).
|
From baseline to the end of treatment at 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。
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4月1日
初级完成 (估计的)
2027年6月1日
研究完成 (估计的)
2027年6月1日
研究注册日期
首次提交
2026年6月30日
首先提交符合 QC 标准的
2026年7月7日
首次发布 (实际的)
2026年7月9日
研究记录更新
最后更新发布 (实际的)
2026年7月9日
上次提交的符合 QC 标准的更新
2026年7月7日
最后验证
2026年7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.