Type 2 Diabetes Mellitus and Downhill Aerobic Exercise Training
7 lipca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Warunki
Typ studiów
Interwencyjne
Zapisy (Szacowany)
34
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Meryem Bektaş Karakuş
- Numer telefonu: +90216 500 41 95
- E-mail: meryem.bektas@acibadem.edu.tr
Lokalizacje studiów
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Maltepe
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Istanbul, Maltepe, Turcja (Türkiye)
- Rekrutacyjny
- Bezmialem Vakıf University Dragos Hospital
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Kontakt:
- Yasin Baki Baydaş, M.D.
- Numer telefonu: +90216 251 65 65
- E-mail: ybaydas@bezmialem.edu.tr
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Aktywny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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6-Minute Walk Test (6MWT)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: From baseline to the end of treatment at 8 weeks
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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)
Ramy czasowe: 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
Ramy czasowe: 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
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Heart Rate Variability (HRV) - LF/HF Ratio
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: From baseline to the end of treatment at 8 weeks
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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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Współpracownicy i badacze
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Sponsor
Współpracownicy
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 kwietnia 2026
Zakończenie podstawowe (Szacowany)
1 czerwca 2027
Ukończenie studiów (Szacowany)
1 czerwca 2027
Daty rejestracji na studia
Pierwszy przesłany
30 czerwca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
7 lipca 2026
Pierwszy wysłany (Rzeczywisty)
9 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
9 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
7 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2026-06/254
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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