Type 2 Diabetes Mellitus and Downhill Aerobic Exercise Training
2026년 7월 7일 업데이트: 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.
연구 개요
상태
모병
연구 유형
중재적
등록 (추정된)
34
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Meryem Bektaş Karakuş
- 전화번호: +90216 500 41 95
- 이메일: meryem.bektas@acibadem.edu.tr
연구 장소
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Maltepe
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Istanbul, Maltepe, 터키 (Türkiye)
- 모병
- Bezmialem Vakıf University Dragos Hospital
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연락하다:
- Yasin Baki Baydaş, M.D.
- 전화번호: +90216 251 65 65
- 이메일: ybaydas@bezmialem.edu.tr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Downhill Walking
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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.
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활성 비교기: Level Walking
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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6-Minute Walk Test (6MWT)
기간: From baseline to the end of treatment at 8 weeks
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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.
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From baseline to the end of treatment at 8 weeks
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Measurement of Peripheral Muscle Strength
기간: From baseline to the end of treatment at 8 weeks
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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.
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From baseline to the end of treatment at 8 weeks
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Heart Rate Variability (HRV) - Root Mean Square of Successive Differences (RMSSD)
기간: 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.
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From baseline to the end of treatment at 8 weeks
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Heart Rate Variability (HRV) - Standard Deviation of NN Intervals (SDNN)
기간: 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.
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From baseline to the end of treatment at 8 weeks
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Heart Rate Variability (HRV) - Mean RR Interval
기간: 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.
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From baseline to the end of treatment at 8 weeks
|
|
Heart Rate Variability (HRV) - LF/HF Ratio
기간: 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
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Fatigue Severity Scale (FSS)
기간: From baseline to the end of treatment at 8 weeks
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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.
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From baseline to the end of treatment at 8 weeks
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Blood Test Results: Glycated Hemoglobin (HbA1c)
기간: From baseline to the end of treatment at 8 weeks
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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 (%).
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From baseline to the end of treatment at 8 weeks
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Blood Test Results: Fasting Blood Glucose (FBG)
기간: From baseline to the end of treatment at 8 weeks
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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).
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From baseline to the end of treatment at 8 weeks
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Lipid Profile: Low-Density Lipoprotein (LDL) Cholesterol
기간: From baseline to the end of treatment at 8 weeks
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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).
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From baseline to the end of treatment at 8 weeks
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Lipid Profile: High-Density Lipoprotein (HDL) Cholesterol
기간: 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).
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From baseline to the end of treatment at 8 weeks
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Lipid Profile: Triglycerides
기간: 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).
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From baseline to the end of treatment at 8 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 4월 1일
기본 완료 (추정된)
2027년 6월 1일
연구 완료 (추정된)
2027년 6월 1일
연구 등록 날짜
최초 제출
2026년 6월 30일
QC 기준을 충족하는 최초 제출
2026년 7월 7일
처음 게시됨 (실제)
2026년 7월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 7일
마지막으로 확인됨
2026년 7월 1일
추가 정보
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