Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
NCT ID:
NCT05088993
Eligibility Criteria:
Inclusion Criteria:
* Elderly Saudi men with diabetic polyneuropathy with history of 2 or more falls within the past 12 months
* Diagnosed as having uncontrolled Type 2 Diabetes Mellitus, with glycosylated hemoglobin (HbA1c) level between 7 and 11 and fasting glucose level ranged from 7.0 -11.1 mmol/L.
* Treated only with oral anti-diabetic agents (not taking insulin),
* Pharmacological treatment had to be stable for at least 3 months before the study.
* They will be selected among old subjects that were able to walk independently with or without assistive device, but with poor balance
Exclusion Criteria:
* Type 1 Diabetes Mellitus,
* Patients who had got a score over 19 according to Tinetti scale of balance assessment,
* Patient with malnutrition (BMI \< 21 kg/m2 or with recent weight loss \> 5% body weight in the last month or \> 10% in six months),
* Patients with established hypertension (resting systolic blood pressure \> 140 mm Hg and diastolic blood pressure \> 90 mm Hg,
* With any severe chronic or uncontrolled comorbid condition as recent myocardial infarction, unstable angina, acute congestive heart failure, third degree heart block and uncontrolled arrhythmia.
* Patients will be excluded also if they have abnormal skin integrity e.g. wound or scar tissues or are on other complementary treatment,
* History of serious cerebrovascular or cardiovascular diseases, and severe debilitating musculoskeletal problems).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT05088993
Study Brief:
Protocol Section:
NCT05088993