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.
Who can participate
Age range
60 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* The following condition resulted in the exclusion of the patients from the study at the initial screening stage:
* Patients with Type 1 diabetes, younger than 60 or older than 70 years.
* Participation in any previous training program or diet regimen within the last 6 months.
* Patients with disturbed nutritional status (Mini Nutritional Assessment score less than 11).
* Serious musculoskeletal or cardiopulmonary disorders that can affect patient safety or the study results.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the cardiovascular disease risk at 12-week.
Timeframe: From enrollment to the end of treatment at 12 weeks.
2
Change in the peripheral vascular function at 12-week.
Timeframe: From enrollment to the end of treatment at 12 weeks.