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临床试验/NCT06974435
NCT06974435已完成不适用

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

Umm Al-Qura University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Change in the cardiovascular disease risk at 8-week.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 75 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •Patients younger than 65 or older than
  • •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).

研究组 & 干预措施

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.

干预措施: Interval training and electromagnetic therapy (Behavioral)

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.

干预措施: Electromagnetic therapy (Behavioral)

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.

干预措施: Interval exercise training (Behavioral)

Control group (Group; No-intervention group)

Other

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

干预措施: Control group (No intervention group) (Other)

结局指标

主要结局

Change in the cardiovascular disease risk at 8-week.

时间窗: 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.

时间窗: From enrollment to the end of treatment at 8 weeks.

Lower extremity functioning was evaluated using the Short Physical Performance Battery.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ashraf Abdelaal

Associate Professor

Umm Al-Qura University

研究点 (1)

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