Downhill walking training for type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study randomizes adults with type 2 diabetes to either downhill treadmill walking or level-ground walking for 8 weeks, with sessions twice weekly supervised by a physical therapist. Baseline 6-minute walk tests guide the initial walking speed and progression, and outcomes include functional capacity, peripheral muscle strength, and cardiovascular responses. Both groups progressively increase duration and pace based on initial performance, while adherence and safety are monitored. Exclusion criteria include severe neuropathy, significant retinopathy, nephropathy, amputations, and other conditions that limit safe exercise. The study is conducted at Bezmialem Vakıf University Dragos Hospital in Istanbul, with Acibadem University as lead sponsor and Bezmialem Vakif University as collaborator.

Why it matters

Who can join: the full rules

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

Where it's running

• Bezmialem Vakıf University Dragos Hospital
  Istanbul, Maltepe, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Meryem Bektaş Karakuş
• Email: meryem.bektas@acibadem.edu.tr
• Phone: +90216 500 41 95

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.