NCT06974422Completed
Weight Off-loading Training, Cardiovascular Indices, Diabetes
Efficacy of Aerobic Training Using Lower Body Positive Pressure Technology on Cardiovascular Disease Risk and Peripheral Vascular Health in Patients With Type 2 Diabetes Mellitus. Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 15 May 2025
Brief summary (registry, in English)
Aims: To evaluate the effectiveness of partial weight-bearing during aerobic exercise training on cardiovascular disease risk and peripheral vascular function in patients with type 2 diabetes mellitus. Study design: A Randomized controlled study was conducted in the outpatient rehabilitation unit. Population: Forty-six participants (age 60 -70) with type 2 diabetes mellitus were recruited and randomly allocated into three groups: group A (100% weight-bearing; n=16), group B (75% weight-bearing; n=16), and group C (control group; n=14). Methods: The 2 study groups A and B, received three sessions per week of moderate intensity (60-75% heart rate reserve) aerobic exercise training, for 12 weeks, 50-60 minutes session duration (including warm-up and cool-down), on the antigravity treadmill. The cardiovascular disease risk (evaluated using the Atherosclerotic cardiovascular disease risk estimator plus tool) and peripheral vascular function (presented by ankle-brachial pressure index, calculated by subdividing the ankle systolic blood pressure by the brachial systolic blood pressure) are the main study outcomes. Variables were evaluated pre-study and post-study. Ethical concepts and institutional regulations were adhered during the study. Data were described as mean and standard deviation. Paired samples t-test and one-way ANOVA were used to test within and between-subjects assumptions, respectively, considering p\< 0.05 as the significance level.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 7 May 2025
- Start date
- 1 Aug 2024
- Primary completion date
- 1 Mar 2025
- Lead sponsor
- Umm Al-Qura University
- Diseases
- Type 2 diabetes
- NCT number
- NCT06974422
What you commit to
- Study type: Interventional
- Participants enrolled: 46
- From 1 Aug 2024 to the primary completion date, 1 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in any previous training program or diet regimen within the last 6 months.
Other illness
- The following condition resulted in the exclusion of the patients from the study at the initial screening stage:
- Serious musculoskeletal or cardiopulmonary disorders that can affect patient safety or the study results.
Age
- Patients with Type 1 diabetes, younger than 60 or older than 70 years.
Other
- Patients with disturbed nutritional status (Mini Nutritional Assessment score less than 11).
Who the study is looking for
- Type 2 diabetes mellitus patients with 0.6\< ankle brachial index ≤ 0.9, treated only with oral hypoglycemic medications (Biguanide or Sulfonylureas + Biguanide), oral anti-diabetic drugs combination, with stable pharmacological treatment for at least 3 months before the study.
- Cognitively competent patients, able to walk independently with or without walking aids, assuming a Sedentary lifestyle (less than 30 minutes daily activity) during the last 6 months.
- Type 2 diabetes mellitus for more than 10 years, with glycosylated hemoglobin (HbA1c% %) level more than 7%, and fasting glucose level more than 7.0 mmol/L.
- Age range from 60 to 70 years, with normal/ accepted nutritional status (Mini Nutritional Assessment score more than 11).
Age in the registry: 60 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Umm Al-Qura University Coordinator of this site? Confirm its status | Mecca | Saudi Arabia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.