Impact of Peripheral Neuropathy in Type-II Diabetes Mellitus on Outcome Measures of Weight-Bearing Aerobic Training in Post-Myocardial Infarction Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 主要终点
- Duke Activity Status Index (DASI) questionnaire
研究概览
简要总结
Cardiac rehabilitation (CR) is categorized by the American College of Cardiology "class IA recommendation" in the management of patients with cardiovascular disease (CVD) including post-myocardial infarction (MI) patients, who have reduced functional capacity and impaired quality of life. Studies have reported that post-MI patients enrolled in exercise-based CR (EB-CR) show improved functional capacity, significant decrease risk of re-infarction, and 25% reduction in mortality. Aim: To define the effect of diabetic peripheral neuropathy (DPN) on the outcome measures of exercise based-cardiac rehabilitation (EB-CR) program in post-myocardial infarction (MI) patients with type-II diabetes mellitus (DM).
Methods: Thirty-seven post-MI patients with type-II DM were enrolled in the study within 1-6 months of MI from those referred for cardiac rehabilitation in the cardiac rehabilitation unit, Alexandria Teaching Hospital. Seven patients were lost. Fifteen patients attended 8 weeks of aerobic training program (exercise group; 12 men and 3 women) while 15 patients did not (control group; 11 men and 4 women). The exercise group was assessed for the presence of peripheral neuropathy and patients were accordingly subdivided into those with DPN "group A" and those without "group B". All groups were evaluated at baseline and at the end of the study. Evaluation included Duke Activity Status Index (DASI) questionnaire, 6-minute walk test, and symptom-limited treadmill exercise stress test (EST).
Outcome measures included: DASI score; 6-minute walk test distance (6MWD); and heart rate (HR), blood pressure (BP), rate pressure product (RPP), and functional capacity in metabolic equivalents (METs) measured during EST.
详细描述
The study population included post-MI patients with type-II DM within 1 to 6 months from onset of MI from those referred for cardiac rehabilitation in the cardiac rehabilitation unit, Alexandria Teaching Hospital. Patients were diagnosed as having MI according to the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of MI and DM according to the 2016 American Diabetes Association guidelines.
All patients were assessed by a cardiologist by clinical examination, electrocardiogram and echocardiography. Patients were excluded if they had any contraindication to exercise stress test (EST) or CR,systemic illness other than DM or hypertension, neurological disorders other than DPN, or had loss of protective sensation (anesthesia) and/or ulcerations in the lower limbs.
All patients were informed about the nature of the study and an informed consent was obtained from all of them. The protocol was approved by the ethics committee.
Patients were divided into 2 groups; those enrolled in EB-CR program "exercise group" and those not enrolled in EB-CR program "control group".
Baseline evaluation for both groups included: demographic data collection, history taking, clinical examination, electrophysiological studies to confirm the presence or absence of neuropathy (sural sensory, posterior tibial and deep peroneal motor conduction studies), total neuropathy score to assess the clinical severity of DPN, Duke Activity Status Index questionnaire (DASI) to assess patients' physical activity level, Six-Minute Walk Test, and symptom-limited treadmill EST using Bruce protocol. All patients were on their regular medications including B-blockers during the EST.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed as having MI according to the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of MI
- •DM according to the 2016 American Diabetes Association guidelines
排除标准
- •contraindication to exercise stress test (EST)
- •contraindication to cardiac rehabilitation,
- •systemic illness other than DM or hypertension,
- •neurological disorders other than DPN,
- •had loss of protective sensation (anesthesia)
- •had ulcerations in the lower limbs.
研究组 & 干预措施
Neuropathy group
post-myocardial infarction patients with type-II diabetes mellitus enrolled in the study within 1-6 months of myocardial infarction with peripheral neuropathy , enrolled into exercise program From those referred for cardiac rehabilitation in the cardiac rehabilitation unit, Alexandria Teaching Hospital
干预措施: Exercise based-cardiac rehabilitation (EB-CR) program (Other)
Non-Neuropathy group
post-myocardial infarction patients with type-II diabetes mellitus enrolled in the study within 1-6 months of myocardial infarction without peripheral neuropathy , enrolled into exercise program From those referred for cardiac rehabilitation in the cardiac rehabilitation unit, Alexandria Teaching Hospital
干预措施: Exercise based-cardiac rehabilitation (EB-CR) program (Other)
Control group
post-myocardial infarction patients with type-II diabetes mellitus enrolled in the study within 1-6 months of myocardial infarction, not enrolled into exercise program.
结局指标
主要结局
Duke Activity Status Index (DASI) questionnaire
时间窗: 8 weeks
12 questions of self-administered questionnaire that measures a patient's functional capacity, The index included questions about activities of daily living as personal care, house hold activities and recreational activities. It also correlated activities with peak oxygen uptake. Maximum value 58.2 and Minimum value 0, higher values indicate better functional capacity. Estimated peak oxygen uptake in mL/min = (0.43 \* (duke activity status index) + 9.6
heart rate (HR)
时间窗: 8 weeks
number of heart beats per minute,
rate pressure product (RPP),
时间窗: 8 weeks
is a measure of the stress put on the cardiac muscle based on the number of times it needs to beat per minute (HR) and the arterial blood pressure that it is pumping against
blood pressure (BP),
时间窗: 8 weeks
systolic and diastolic blood pressure in mmHg
Six minute walk test distance
时间窗: 8 weeks
It is used to estimate the functional capacity of the study group. It was done according to the American Thoracic Society (ATS) guidelines for the 6MWT. The 6MWT was performed in an indoors flat straight corridor of 30 meters in length. A stopwatch was used to measure the 6 minutes. Patients were instructed that the target of the test was to: WALK AS FAR AS POSSIBLE for 6 minutes, WITHOUT RUNNING OR JOGGING
次要结局
未报告次要终点
研究者
Yousra Hisham Abdel Fattah
Principle investigator
University of Alexandria