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Type 2 Diabetes Mellitus and Downhill Aerobic Exercise Training

7. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

34

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Tyrkia (Türkiye)
    • Maltepe
      • Istanbul, Maltepe, Tyrkia (Türkiye)
        • Rekruttering
        • Bezmialem Vakıf University Dragos Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Downhill Walking
Annen: Downhill Aerobic Walking Training
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.
Annen: Home exercise session
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.
Aktiv komparator: Level Walking
Annen: Home exercise session
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.
Annen: Level Aerobic Walking Training
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
6-Minute Walk Test (6MWT)
Tidsramme: 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
Measurement of Peripheral Muscle Strength
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
From baseline to the end of treatment at 8 weeks
Fatigue Severity Scale (FSS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

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Sponsor

Acibadem University

Samarbeidspartnere

Bezmialem Vakif University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

30. juni 2026

Først innsendt som oppfylte QC-kriteriene

7. juli 2026

Først lagt ut (Faktiske)

9. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026-06/254

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