Type 2 Diabetes Mellitus and Downhill Aerobic Exercise Training
7 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
34
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Meryem Bektaş Karakuş
- Número de teléfono: +90216 500 41 95
- Correo electrónico: meryem.bektas@acibadem.edu.tr
Ubicaciones de estudio
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Maltepe
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Istanbul, Maltepe, Turquía (Türkiye)
- Reclutamiento
- Bezmialem Vakıf University Dragos Hospital
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Contacto:
- Yasin Baki Baydaş, M.D.
- Número de teléfono: +90216 251 65 65
- Correo electrónico: ybaydas@bezmialem.edu.tr
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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6-Minute Walk Test (6MWT)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: From baseline to the end of treatment at 8 weeks
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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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de abril de 2026
Finalización primaria (Estimado)
1 de junio de 2027
Finalización del estudio (Estimado)
1 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
30 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de julio de 2026
Publicado por primera vez (Actual)
9 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-06/254
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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