Upper Versus Lower Limb Exercises on Intermittent Claudication in Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- glycated haemoglobin (HbA1C)
研究概览
简要总结
Sixty patients with intermittent claudication and type 2 diabetes mellitus. Their age will ranged from 45-55 years old. They recruited from internal department at Damanhour Medical National Institute (DMNI), Damanhour, Beheira Governorate, Egypt. Patients randomly assigned into three equal groups:
Group (A):
Upper limb exercises group consist of 20 patients. They received arm cranking exercise three times per week for three consecutive months plus routine physiotherapy program.
Group (B):
Lower limb exercises group consist of 20 patients. They received bicycling exercise three times per week for three consecutive months plus routine physiotherapy program.
Group (C):
The control group consisted of 20 patients. They received only routine physiotherapy program.
详细描述
- Subjects:
Sixty patients with intermittent claudication and type 2 diabetes mellitus. Their age ranged from 45-55 years old. They recruited from internal department at Damanhour Medical National Institute (DMNI), Damanhour, Beheira Governorate, Egypt. Patients randomly assigned into three equal groups:
Group (A):
Upper limb exercises group consist of 20 patients. They received arm cranking exercise three times per week for three consecutive months plus routine physiotherapy program.
Group (B):
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sixty patients with type 2 diabetes mellitus and intermittent claudication.
- •Patients with diabetes at least 5 years.
- •Both genders were included.
- •Their age will be ranged from 45-55 years old.
- •Patients referred from physician of internal medicine diagnosed as controlled type 2 diabetes (HbA1c 7-7.5%) for the previous 3 months.
- •Their body mass index will be ranged from 25.0 to 34.9 kg/m2.
排除标准
- •Pregnant women.
- •Malignancy.
- •Other medical conditions such as uncontrolled hypertension and osteoporosis.
- •Past medical history included conditions that may influence the provision of physiotherapy interventions such as (severe asthma, chronic airflow limitation, bronchiectasis, ankylosing spondylitis or lumbar disc prolapse).
结局指标
主要结局
glycated haemoglobin (HbA1C)
时间窗: three consecutive months
It is the average of blood glucose (sugar) levels for the last two to three months. If you have diabetes, an ideal HbA1c level is 48mmol/mol (6.5%) or below
maximum walking distance (MWD) in meter
时间窗: three consecutive months
the distance that had been walked on the treadmill when patients were unable to continue because of severe claudication pain
pain free walking distance (PFWD) in meter
时间窗: three consecutive months
the distance that patients can walk on the treadmill before claudication pain begins
claudication score
时间窗: three consecutive months
Claudication pain scale is a continuous scale from 1, indicating no pain, to 5 indicating severe pain
Ankle/brachial indices (ABI) by doppler ultrasound
时间窗: three consecutive months
次要结局
未报告次要终点
研究者
El-Sayed Essam
principle investigator
Cairo University