Cardiovascular Disease, Diabetes Mellitus Type 2NCT06974422
Weight Off-loading Training, Cardiovascular Indices, Diabetes
A study testing Partial weight bearing during aerobic exercise training, Full weight bearing during aerobic exercise training and Regular oral anti-diabetic medications. in people with Cardiovascular Disease, Diabetes Mellitus Type 2 and Peripheral Vascular Disorder Due to Diabetes Mellitus, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 70 years
- Conditions the study is for
- Cardiovascular Disease, Diabetes Mellitus Type 2, Peripheral Vascular Disorder Due to Diabetes Mellitus
- What is being tested?
- Partial weight bearing during aerobic exercise training, Full weight bearing during aerobic exercise training and Regular oral anti-diabetic medications.
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Aug 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
Diabetes mellitus (DM) continues as a global alarming epidemic, with an increasingly growing health burden and complications across all socioeconomic levels. Type 2 diabetes mellitus (T2DM) is associated with wide peripheral vascular complications, manifested in deteriorated lower limb blood pressure and vascular endothelial dysfunction. Prevalence of peripheral vascular disorder varies with T2DM duration, ranging from 1.2% in newly discovered T2DM cases, to about 12.5% (after 18 years of T2DM affection), and reaches 20-30% in some reports.
The abnormally increased cardiovascular disease CVD (either through traditional risk factors or direct diabetes effects) is expected to continue rising alongside DM. Adequate management for DM and associated CVD risk factors is essential to ameliorate the progression of DM and CVD.
Being active is beneficial in alleviating the peripheral vascular disease burden in patients with disturbed peripheral vascular function. Supervised treadmill exercise training can improve functional performance in patients with peripheral arterial disorders. Increasing patients' activity level is a cornerstone item in patients with T2DM rehabilitation programs.
Patients may be challenged by the disease-related pathophysiological changes and treatment requirements. The hallmark of inactivity status that dominates in patients with T2DM negatively impacts their performance during weight-bearing activities. The existence of pain, peripheral vascular disturbances, abnormally increased and unequally distributed plantar stress, all limit patients' participation and compliance with the full weight-bearing training programs.
Introducing the well-controlled partial weight-bearing through the lower body positive pressure technology during exercise training programs augments patients' active participation, minimizes weight-bearing related musculoskeletal limitations, while maintaining normal locomotion dynamics and training-related physiological responses.
Conflicts arise regarding the benefits of full and partial weight-bearing exercise training for patients with T2DM. Previous studies investigated the effects of modulating the weight-bearing status during aerobic exercise training on different health aspects and concluded conflicting results. Quite recently published studies reported the safety and efficacy of the partial weight-bearing AET training in improving the T2DM-related musculoskeletal constraints.
To our knowledge, this study is the first to investigate the effects of partial weight bearing during AET on cardiovascular variables in patients with T2DM. The objectives of this study were to evaluate the effectiveness of partial weight off-loading during aerobic exercise training, using the antigravity treadmill, on the cardiovascular disease risk and the peripheral vascular health (presented by the ankle-brachial pressure index) in patients with T2DM.
- Conditions
- Cardiovascular Disease, Diabetes Mellitus Type 2, Peripheral Vascular Disorder Due to Diabetes Mellitus
- Being tested
- Partial weight bearing during aerobic exercise training, Full weight bearing during aerobic exercise training, Regular oral anti-diabetic medications.
- Keywords
- Exercise, Partial Weight-Bearing, Type 2 Diabetes Mellitus, Cardiovascular Disease, Ankle Brachial Index
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial weight bearing during aerobic exercise trainingBehavioural
Also called Antigravity treadmill aerobic exercise training, partial weight offloading during aerobic exercise training
Partial weight bearing (25% weight support) during the moderate intensity aerobic exercise training on the antigravity treadmill
Full weight bearing during aerobic exercise trainingBehavioural
Full weight bearing (100% weight loading, 0% weight support) during moderate intensity aerobic exercise training on the antigravity treadmill.
Regular oral anti-diabetic medications.Drug
Participants in the control group (group C) received regular oral anti-diabetic medications.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group-1 (group-A; 0% weight off-loading) | Active comparator | This group (100% weight-bearing group) 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. Participants also received regular oral anti-diabetic medications. Receives: Behavioral: Full weight bearing during aerobic exercise training |
| Experimental Group-2 (group-B; 25% weight off-loading) | Experimental | This group (27% weight-bearing group) 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. Participants also received regular oral anti-diabetic medications. Receives: Behavioral: Partial weight bearing during aerobic exercise training |
| Control group (Group; Non-exercising group) | Other | The control group participants received the same pre- and post-study evaluations as those for the study groups A and B, but did not participate in any aerobic exercise training on the antigravity treadmill. Participants only received regular oral anti-diabetic medications. Receives: Drug: Regular oral anti-diabetic medications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the cardiovascular disease risk at 12-week.
The cardiovascular disease risk was evaluated using the Atherosclerotic cardiovascular disease risk estimator plus tool, and was evaluated pre-study and at 12 weeks (end of the study).
Measured: From enrollment to the end of treatment at 12 weeks.
Change in the peripheral vascular function at 12-week.
The peripheral vascular function (presented by ankle-brachial pressure index) was calculated by dividing the ankle systolic blood pressure by the brachial systolic blood pressure, and was evaluated pre-study and at 12 weeks (end of the study).
Measured: From enrollment to the end of treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Aug 2024
- Primary completion1 Mar 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease, Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Abdelaal, Umm Al-Qura University
- Investigators
- ASHRAF AM ABDELAAL, Ph.D., Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974422
- Sponsor's protocol ID
- SNEZ070525
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For privacy reasons, data can not be exposed until results' publication. Data summary will be confidentially provided upon request under limited situations.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06974422
- Acronym / sponsor ID
- SNEZ070525
- Conditions
- Cardiovascular Disease, Diabetes Mellitus Type 2, Peripheral Vascular Disorder Due to Diabetes Mellitus
- Keywords
- Exercise, Partial Weight-Bearing, Type 2 Diabetes Mellitus, Cardiovascular Disease, Ankle Brachial Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Diabetes mellitus (DM) continues as a global alarming epidemic, with an increasingly growing health burden and complications across all socioeconomic levels. Type 2 diabetes mellitus (T2DM) is associated with wide peripheral vascular complications, manifested in deteriorated lower limb blood pressure and vascular endothelial dysfunction. Prevalence of peripheral vascular disorder varies with T2DM duration, ranging from 1.2% in newly discovered T2DM cases, to about 12.5% (after 18 years of T2DM affection), and reaches 20-30% in some reports.
The abnormally increased cardiovascular disease CVD (either through traditional risk factors or direct diabetes effects) is expected to continue rising alongside DM. Adequate management for DM and associated CVD risk factors is essential to ameliorate the progression of DM and CVD.
Being active is beneficial in alleviating the peripheral vascular disease burden in patients with disturbed peripheral vascular function. Supervised treadmill exercise training can improve functional performance in patients with peripheral arterial disorders. Increasing patients' activity level is a cornerstone item in patients with T2DM rehabilitation programs.
Patients may be challenged by the disease-related pathophysiological changes and treatment requirements. The hallmark of inactivity status that dominates in patients with T2DM negatively impacts their performance during weight-bearing activities. The existence of pain, peripheral vascular disturbances, abnormally increased and unequally distributed plantar stress, all limit patients' participation and compliance with the full weight-bearing training programs.
Introducing the well-controlled partial weight-bearing through the lower body positive pressure technology during exercise training programs augments patients' active participation, minimizes weight-bearing related musculoskeletal limitations, while maintaining normal locomotion dynamics and training-related physiological responses.
Conflicts arise regarding the benefits of full and partial weight-bearing exercise training for patients with T2DM. Previous studies investigated the effects of modulating the weight-bearing status during aerobic exercise training on different health aspects and concluded conflicting results. Quite recently published studies reported the safety and efficacy of the partial weight-bearing AET training in improving the T2DM-related musculoskeletal constraints.
To our knowledge, this study is the first to investigate the effects of partial weight bearing during AET on cardiovascular variables in patients with T2DM. The objectives of this study were to evaluate the effectiveness of partial weight off-loading during aerobic exercise training, using the antigravity treadmill, on the cardiovascular disease risk and the peripheral vascular health (presented by the ankle-brachial pressure index) in patients with T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group-1 (group-A; 0% weight off-loading) | Active comparator | Behavioral: Full weight bearing during aerobic exercise trainingThis group (100% weight-bearing group) 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. Participants also received regular oral anti-diabetic medications. |
| Experimental Group-2 (group-B; 25% weight off-loading) | Experimental | Behavioral: Partial weight bearing during aerobic exercise trainingThis group (27% weight-bearing group) 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. Participants also received regular oral anti-diabetic medications. |
| Control group (Group; Non-exercising group) | Other | Drug: Regular oral anti-diabetic medications.The control group participants received the same pre- and post-study evaluations as those for the study groups A and B, but did not participate in any aerobic exercise training on the antigravity treadmill. Participants only received regular oral anti-diabetic medications. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial weight bearing during aerobic exercise trainingAlso: Antigravity treadmill aerobic exercise training, partial weight offloading during aerobic exercise trainingPartial weight bearing (25% weight support) during the moderate intensity aerobic exercise training on the antigravity treadmill | Behavioural | Experimental Group-2 (group-B; 25% weight off-loading) |
| Full weight bearing during aerobic exercise trainingFull weight bearing (100% weight loading, 0% weight support) during moderate intensity aerobic exercise training on the antigravity treadmill. | Behavioural | Experimental Group-1 (group-A; 0% weight off-loading) |
| Regular oral anti-diabetic medications.Participants in the control group (group C) received regular oral anti-diabetic medications. | Drug | Control group (Group; Non-exercising group) |
Primary outcome
Change in the cardiovascular disease risk at 12-week.
Time frame: From enrollment to the end of treatment at 12 weeks.
The cardiovascular disease risk was evaluated using the Atherosclerotic cardiovascular disease risk estimator plus tool, and was evaluated pre-study and at 12 weeks (end of the study).
Change in the peripheral vascular function at 12-week.
Time frame: From enrollment to the end of treatment at 12 weeks.
The peripheral vascular function (presented by ankle-brachial pressure index) was calculated by dividing the ankle systolic blood pressure by the brachial systolic blood pressure, and was evaluated pre-study and at 12 weeks (end of the study).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No. For privacy reasons, data can not be exposed until results' publication. Data summary will be confidentially provided upon request under limited situations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ASHRAF AM ABDELAAL, Ph.D. principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial weight bearing during aerobic exercise training, Full weight bearing during aerobic exercise training and Regular oral anti-diabetic medications. in people with Cardiovascular Disease, Diabetes Mellitus Type 2 and Peripheral Vascular Disorder Due to Diabetes Mellitus, run by Umm Al-Qura University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the cardiovascular disease risk at 12-week. (time frame: From enrollment to the end of treatment at 12 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.