Interval Training and Electromagnetic Therapy on Cardiovascular Disease Risk in Diabetic Elderly

NCT06974435 | Completed DMC

• 1 other identifier: HAPO-02-K-012-2022-03-997
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiovascular Disease Risk Reduction; Diabetes; Lower Extremity Dysfunction

Keywords

Cardiovascular disease risk; Exercise; Magnetic Therapy; Lower Limb Function; Diabetes

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From enrollment to the end of treatment at 8 weeks.

Study Arms (4)

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.

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.

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.

Behavioral: Interval exercise training

Control group (Group; No-intervention group)

OTHER

Control group (Group; No-intervention group): received only the medical treatment.

Other: Control group (No intervention group)

Interventions

Interval training and electromagnetic therapy BEHAVIORAL

Combined application of moderate intensity interval training and low frequency pulsed electromagnetic field therapy, in addition to pharmacotherapy.

Group-A (interval training and electromagnetic therapy group; n=25)

Interval exercise training BEHAVIORAL

Application of moderate intensity interval training, in addition to pharmacotherapy.

Group-C (interval training group; n=25)

Electromagnetic therapy BEHAVIORAL

Application of low-frequency pulsed electromagnetic field therapy, in addition to pharmacotherapy.

Group-B (electromagnetic therapy group; n=25)

Control group (No intervention group) OTHER

Only Pharmacotherapy.

Control group (Group; No-intervention group)

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Umm Al-Qura University

Mecca, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity

Interventions

Magnetic Field Therapy; Control Groups

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• ASHRAF AM ABDELAAL, Ph.D.

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: September 1, 2024
• Primary Completion: March 7, 2025
• Study Completion: April 6, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)