Type 2 Diabetes Mellitus and Downhill Aerobic Exercise Training
7 de julho de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
34
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Meryem Bektaş Karakuş
- Número de telefone: +90216 500 41 95
- E-mail: meryem.bektas@acibadem.edu.tr
Locais de estudo
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Maltepe
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Istanbul, Maltepe, Turquia (Türkiye)
- Recrutamento
- Bezmialem Vakıf University Dragos Hospital
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Contato:
- Yasin Baki Baydaş, M.D.
- Número de telefone: +90216 251 65 65
- E-mail: ybaydas@bezmialem.edu.tr
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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6-Minute Walk Test (6MWT)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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 (%).
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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)
Prazo: 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
Prazo: 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).
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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
Prazo: 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
Prazo: 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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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de abril de 2026
Conclusão Primária (Estimado)
1 de junho de 2027
Conclusão do estudo (Estimado)
1 de junho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
30 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de julho de 2026
Primeira postagem (Real)
9 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-06/254
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