Cardiovascular Disease Risk ReductionNCT06974435
Interval Training and Electromagnetic Therapy on Cardiovascular Disease Risk in Diabetic Elderly
A study testing Interval training and electromagnetic therapy, Interval exercise training and Electromagnetic therapy in people with Cardiovascular Disease Risk Reduction and Diabetes, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial summary
Aims: To evaluate the combined effect of moderate intensity interval training and low frequency pulsed electromagnetic field therapy on cardiovascular disease risk and lower extremity functioning in the elderly with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Cardiovascular Disease Risk Reduction, Diabetes, Lower Extremity Dysfunction
- What is being tested?
- Interval training and electromagnetic therapy, Interval exercise training and Electromagnetic therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2024to 6 Apr 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Sedentary older adult (65-75 years old).
- Diagnosed with type 2 diabetes mellitus.
- Glycosylated hemoglobin ≥ 6.5%.
- Receiving oral anti-diabetic medications only.
- Cognitively competent and able to understand and follow instructions.
Who cannot join
- Patients younger than 65 or older than 75.
- Diagnosed with type 1 diabetes.
- Included in an active exercise training or physiotherapy program within the last 6 months.
- With serious cardiac insults as myocardial infarction, lower limbs metal implants (internal fixation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Interval Training and Low-Frequency Pulsed Electromagnetic Field Therapy on Improving Cardiovascular Disease Risk and Lower Extremity Function in Diabetic Elderly: Randomized Controlled Trial
Aims: To evaluate the combined effect of moderate intensity interval training and low frequency pulsed electromagnetic field therapy on cardiovascular disease risk and lower extremity functioning in the elderly with type 2 diabetes mellitus.
Methods: One hundred patients with type 2 diabetes mellitus were randomly allocated into four groups: group A (received moderate intensity interval training+low frequency pulsed electromagnetic field therapy; n=25), group-B (received low frequency pulsed electromagnetic field therapy only; n=25), group C (received moderate intensity interval training only; n=25), and (control group; no intervention; n=25). Treatment programs for groups A, B, and C were in the form of twice-weekly sessions for 8 weeks. Variables were evaluated at the beginning and the end of the study. The cardiovascular disease risk (evaluated using the Atherosclerotic Cardiovascular Disease risk estimator plus tool, Framingham Cardiovascular Disease risk estimation tool, and the mean arterial pressure methods). Lower extremity functioning was evaluated using the Short Physical Performance Battery. Within and between-subjects statistical comparisons were performed to test the hypothesis (to test whether the combined application of moderate intensity interval training+low frequency pulsed electromagnetic field therapy is effective in improving the cardiovascular disease risk and lower limbs functional status in ethe lderly with type 2 diabetes mellitus), A P-value of <0.05 was considered significant.
Read the detailed description
Diabetes mellitus is a continuously growing epidemic all over the world. The continuously increasing number of patients with diabetes mellitus and its complications is a serious challenge to patients and health care providers. Cardiovascular disease is the primary cause of death in patients with diabetes mellitus worldwide. The presence of diabetes mellitus in addition to getting older magnifies the cardiovascular disease risk and predisposes to its occurrence at an earlier age. The prevalence of different cardiovascular disease types within patients with diabetes reached 18 % in Saudi Arabia.
The Lower limb diabetes-related complications are common and usually associated with increased morbidity and mortality. Diabetes mellitus contributes significantly to the development of peripheral vascular disorders, ischemia, and even amputation. A strong correlation exists between Diabetes mellitus and cardiovascular disease, about 44% and 52% of deaths in patients with type 1 and type 2 diabetes mellitus, respectively, are due to cardiovascular disease. Diabetes mellitus magnifies the chance of dying from cardiovascular disorders by two to four times in patients with diabetes compared to those without diabetes. This fact highlights the importance of introducing cardiovascular disease risk-reduction strategies in the management programs.
Furthermore, cardiovascular disease risk is proportionally increased and correlated with the hyperglycemia status even before diabetes diagnosis. The existence of other factors, such as hypertension, dyslipidemia, and obesity, accelerates the development of cardiovascular disease in patients with diabetes. So, early identification and management of cardiovascular disease risk is a major concern during diabetes mellitus management. Diabetes mellitus is tightly correlated as a causative agent to peripheral circulatory disturbances, limb ischemia, and even amputation. Early and proper management of the diabetes-related lower limb abnormalities is crucial for minimizing complications and dysfunction.
Moderate to high-intensity interval training is commonly included in the management programs for patients with type 2 diabetes mellitus. Studies demonstrated favorable effects of exercise training on cardiovascular and metabolic parameters in patients with diabetes mellitus. Physical training can improve cardiopulmonary and metabolic variables that, in turn, can ameliorate complications' progression and improve disease prognosis.
Engagement in regular physical training can significantly reduce the cardiovascular disease risk. An increase of weekly activity hours by 11.25 metabolic equivalents can reduce cardiovascular disease mortality by 23%. Increased physical activity has a positive impact on cardiovascular, musculoskeletal, metabolic, and psychosocial function in patients with DM, resulting in a lower mortality rate.
Low-frequency pulsed electromagnetic field therapy has beneficial and prognostic impacts on metabolic profile in patients with type 2 diabetes mellitus due to its favorable, vasoactive, neuro-stimulatory, and analgesic effects. Studies clarified favorable effects of therapeutic pulsed electromagnetic field application on different musculoskeletal, cardiovascular, and metabolic parameters in patients with type 2 diabetes mellitus. A Recent study demonstrated significant effects of cross-over application of the electromagnetic field therapy and interval exercise training on the balance and peripheral vascular status in patients with diabetes mellitus.
To our knowledge and recent literature, no study has investigated the effects of combined application of both interval training and low-frequency pulsed electromagnetic field therapy on cardiovascular disease risk and lower extremity function in older adults with type 2 diabetes mellitus.
- Being tested
- Interval training and electromagnetic therapy, Interval exercise training, Electromagnetic therapy, Control group (No intervention group)
- Keywords
- Cardiovascular disease risk, Exercise, Magnetic Therapy, Lower Limb Function, Diabetes
- Medical subject headings
- Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval training and electromagnetic therapyBehavioural
Combined application of moderate intensity interval training and low frequency pulsed electromagnetic field therapy, in addition to pharmacotherapy.
Interval exercise trainingBehavioural
Application of moderate intensity interval training, in addition to pharmacotherapy.
Electromagnetic therapyBehavioural
Application of low-frequency pulsed electromagnetic field therapy, in addition to pharmacotherapy.
Control group (No intervention group)Other
Only Pharmacotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Group-A (interval training and electromagnetic therapy group; n=25) | Experimental | Group A: received moderate intensity interval training in addition to low-frequency pulsed electromagnetic field therapy. The treatment program was in the form of twice-weekly sessions for 8 weeks, in addition to medical treatment. Receives: Behavioral: Interval training and electromagnetic therapy |
| Group-B (electromagnetic therapy group; n=25) | Experimental | Group B: received low-frequency pulsed electromagnetic field therapy only. The treatment program was in the form of twice-weekly sessions for 8 weeks, in addition to medical treatment. Receives: Behavioral: Electromagnetic therapy |
| Group-C (interval training group; n=25) | Experimental | Group C: received moderate intensity interval training. The treatment program was in the form of twice-weekly sessions for 8 weeks, in addition to medical treatment. Receives: Behavioral: Interval exercise training |
| Control group (Group; No-intervention group) | Other | Control group (Group; No-intervention group): received only the medical treatment. Receives: Other: Control group (No intervention group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the cardiovascular disease risk at 8-week.
The cardiovascular disease risk was evaluated using the Atherosclerotic Cardiovascular Disease risk estimator plus tool, the Framingham Cardiovascular Disease risk estimation tool, and the mean arterial pressure methods.
Measured: From enrollment to the end of treatment at 8 weeks.
Change in the lower extremity functioning at 8-week.
Lower extremity functioning was evaluated using the Short Physical Performance Battery.
Measured: From enrollment to the end of treatment at 8 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 Sep 2024
- Primary completion7 Mar 2025
- Study completion6 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease Risk ReductionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 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
- NCT06974435
- Sponsor's protocol ID
- HAPO-02-K-012-2022-03-997
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 16 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 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Interval Training and Low-Frequency Pulsed Electromagnetic Field Therapy on Improving Cardiovascular Disease Risk and Lower Extremity Function in Diabetic Elderly: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06974435
- Acronym / sponsor ID
- HAPO-02-K-012-2022-03-997
- Keywords
- Cardiovascular disease risk, Exercise, Magnetic Therapy, Lower Limb Function, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 6 Apr 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 combined effect of moderate intensity interval training and low frequency pulsed electromagnetic field therapy on cardiovascular disease risk and lower extremity functioning in the elderly with type 2 diabetes mellitus.
Methods: One hundred patients with type 2 diabetes mellitus were randomly allocated into four groups: group A (received moderate intensity interval training+low frequency pulsed electromagnetic field therapy; n=25), group-B (received low frequency pulsed electromagnetic field therapy only; n=25), group C (received moderate intensity interval training only; n=25), and (control group; no intervention; n=25). Treatment programs for groups A, B, and C were in the form of twice-weekly sessions for 8 weeks. Variables were evaluated at the beginning and the end of the study. The cardiovascular disease risk (evaluated using the Atherosclerotic Cardiovascular Disease risk estimator plus tool, Framingham Cardiovascular Disease risk estimation tool, and the mean arterial pressure methods). Lower extremity functioning was evaluated using the Short Physical Performance Battery. Within and between-subjects statistical comparisons were performed to test the hypothesis (to test whether the combined application of moderate intensity interval training+low frequency pulsed electromagnetic field therapy is effective in improving the cardiovascular disease risk and lower limbs functional status in ethe lderly with type 2 diabetes mellitus), A P-value of <0.05 was considered significant.
Detailed description
Diabetes mellitus is a continuously growing epidemic all over the world. The continuously increasing number of patients with diabetes mellitus and its complications is a serious challenge to patients and health care providers. Cardiovascular disease is the primary cause of death in patients with diabetes mellitus worldwide. The presence of diabetes mellitus in addition to getting older magnifies the cardiovascular disease risk and predisposes to its occurrence at an earlier age. The prevalence of different cardiovascular disease types within patients with diabetes reached 18 % in Saudi Arabia.
The Lower limb diabetes-related complications are common and usually associated with increased morbidity and mortality. Diabetes mellitus contributes significantly to the development of peripheral vascular disorders, ischemia, and even amputation. A strong correlation exists between Diabetes mellitus and cardiovascular disease, about 44% and 52% of deaths in patients with type 1 and type 2 diabetes mellitus, respectively, are due to cardiovascular disease. Diabetes mellitus magnifies the chance of dying from cardiovascular disorders by two to four times in patients with diabetes compared to those without diabetes. This fact highlights the importance of introducing cardiovascular disease risk-reduction strategies in the management programs.
Furthermore, cardiovascular disease risk is proportionally increased and correlated with the hyperglycemia status even before diabetes diagnosis. The existence of other factors, such as hypertension, dyslipidemia, and obesity, accelerates the development of cardiovascular disease in patients with diabetes. So, early identification and management of cardiovascular disease risk is a major concern during diabetes mellitus management. Diabetes mellitus is tightly correlated as a causative agent to peripheral circulatory disturbances, limb ischemia, and even amputation. Early and proper management of the diabetes-related lower limb abnormalities is crucial for minimizing complications and dysfunction.
Moderate to high-intensity interval training is commonly included in the management programs for patients with type 2 diabetes mellitus. Studies demonstrated favorable effects of exercise training on cardiovascular and metabolic parameters in patients with diabetes mellitus. Physical training can improve cardiopulmonary and metabolic variables that, in turn, can ameliorate complications' progression and improve disease prognosis.
Engagement in regular physical training can significantly reduce the cardiovascular disease risk. An increase of weekly activity hours by 11.25 metabolic equivalents can reduce cardiovascular disease mortality by 23%. Increased physical activity has a positive impact on cardiovascular, musculoskeletal, metabolic, and psychosocial function in patients with DM, resulting in a lower mortality rate.
Low-frequency pulsed electromagnetic field therapy has beneficial and prognostic impacts on metabolic profile in patients with type 2 diabetes mellitus due to its favorable, vasoactive, neuro-stimulatory, and analgesic effects. Studies clarified favorable effects of therapeutic pulsed electromagnetic field application on different musculoskeletal, cardiovascular, and metabolic parameters in patients with type 2 diabetes mellitus. A Recent study demonstrated significant effects of cross-over application of the electromagnetic field therapy and interval exercise training on the balance and peripheral vascular status in patients with diabetes mellitus.
To our knowledge and recent literature, no study has investigated the effects of combined application of both interval training and low-frequency pulsed electromagnetic field therapy on cardiovascular disease risk and lower extremity function in older adults with type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group-A (interval training and electromagnetic therapy group; n=25) | Experimental | Behavioral: Interval training and electromagnetic therapyGroup A: received moderate intensity interval training in addition to low-frequency pulsed electromagnetic field therapy. The treatment program was in the form of twice-weekly sessions for 8 weeks, in addition to medical treatment. |
| Group-B (electromagnetic therapy group; n=25) | Experimental | Behavioral: Electromagnetic therapyGroup B: received low-frequency pulsed electromagnetic field therapy only. The treatment program was in the form of twice-weekly sessions for 8 weeks, in addition to medical treatment. |
| Group-C (interval training group; n=25) | Experimental | Behavioral: Interval exercise trainingGroup C: received moderate intensity interval training. The treatment program was in the form of twice-weekly sessions for 8 weeks, in addition to medical treatment. |
| Control group (Group; No-intervention group) | Other | Other: Control group (No intervention group)Control group (Group; No-intervention group): received only the medical treatment. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Sedentary older adult (65-75 years old).
- Diagnosed with type 2 diabetes mellitus.
- Glycosylated hemoglobin ≥ 6.5%.
- Receiving oral anti-diabetic medications only.
- Cognitively competent and able to understand and follow instructions.
Key exclusion criteria (4 listed)
- Patients younger than 65 or older than 75.
- Diagnosed with type 1 diabetes.
- Included in an active exercise training or physiotherapy program within the last 6 months.
- With serious cardiac insults as myocardial infarction, lower limbs metal implants (internal fixation).
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 |
|---|---|---|
| Interval training and electromagnetic therapyCombined application of moderate intensity interval training and low frequency pulsed electromagnetic field therapy, in addition to pharmacotherapy. | Behavioural | Group-A (interval training and electromagnetic therapy group; n=25) |
| Interval exercise trainingApplication of moderate intensity interval training, in addition to pharmacotherapy. | Behavioural | Group-C (interval training group; n=25) |
| Electromagnetic therapyApplication of low-frequency pulsed electromagnetic field therapy, in addition to pharmacotherapy. | Behavioural | Group-B (electromagnetic therapy group; n=25) |
| Control group (No intervention group)Only Pharmacotherapy. | Other | Control group (Group; No-intervention group) |
Primary outcome
Change in the cardiovascular disease risk at 8-week.
Time frame: From enrollment to the end of treatment at 8 weeks.
The cardiovascular disease risk was evaluated using the Atherosclerotic Cardiovascular Disease risk estimator plus tool, the Framingham Cardiovascular Disease risk estimation tool, and the mean arterial pressure methods.
Change in the lower extremity functioning at 8-week.
Time frame: From enrollment to the end of treatment at 8 weeks.
Lower extremity functioning was evaluated using the Short Physical Performance Battery.
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 16 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 Interval training and electromagnetic therapy, Interval exercise training and Electromagnetic therapy in people with Cardiovascular Disease Risk Reduction and Diabetes, 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 5 inclusion and 4 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 16 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 8-week. (time frame: From enrollment to the end of treatment at 8 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 16 May 2025.