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
- maximum walking distance (MWD) in meter
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).
研究组 & 干预措施
Upper limb exercises group.
Upper limb exercises group consist of 20 patients. They received arm cranking exercise and routine physiotherapy program.
干预措施: The arm crank ergometer (Device)
Upper limb exercises group.
Upper limb exercises group consist of 20 patients. They received arm cranking exercise and routine physiotherapy program.
干预措施: treadmill (Device)
Lower limb exercises group.
Lower limb exercises group consist of 20 patients. They received bicycling exercise and routine physiotherapy program.
干预措施: bicycle ergometer (Device)
Lower limb exercises group.
Lower limb exercises group consist of 20 patients. They received bicycling exercise and routine physiotherapy program.
干预措施: treadmill (Device)
The control group.
The control group consisted of 20 patients. They received only routine physiotherapy program.
干预措施: treadmill (Device)
结局指标
主要结局
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
Ankle/brachial indices (ABI) by doppler ultrasound
时间窗: three consecutive months
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
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
次要结局
未报告次要终点
研究者
El-Sayed Essam
principle investigator
Cairo University