Upper Versus Lower Limb Exercises on Intermittent Claudication in Diabetic Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- maximum walking distance (MWD) in meter
Study Overview
Brief Summary
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.
Detailed Description
- 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):
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 45 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Arms & Interventions
Upper limb exercises group.
Upper limb exercises group consist of 20 patients. They received arm cranking exercise and routine physiotherapy program.
Intervention: 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.
Intervention: treadmill (Device)
Lower limb exercises group.
Lower limb exercises group consist of 20 patients. They received bicycling exercise and routine physiotherapy program.
Intervention: bicycle ergometer (Device)
Lower limb exercises group.
Lower limb exercises group consist of 20 patients. They received bicycling exercise and routine physiotherapy program.
Intervention: treadmill (Device)
The control group.
The control group consisted of 20 patients. They received only routine physiotherapy program.
Intervention: treadmill (Device)
Outcomes
Primary Outcomes
maximum walking distance (MWD) in meter
Time Frame: 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
Time Frame: three consecutive months
glycated haemoglobin (HbA1C)
Time Frame: 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
Time Frame: three consecutive months
the distance that patients can walk on the treadmill before claudication pain begins
claudication score
Time Frame: three consecutive months
Claudication pain scale is a continuous scale from 1, indicating no pain, to 5 indicating severe pain
Secondary Outcomes
No secondary outcomes reported
Investigators
El-Sayed Essam
principle investigator
Cairo University