Upper Versus Lower Limb Exercises on Intermittent Claudication in Diabetic Patients

Cairo University (CU)

Status: Completed

Conditions: Intermittent Claudication

Treatments: Device: treadmill; Device: bicycle ergometer; Device: The arm crank ergometer

Study type: Interventional

Funder types: Other

Identifiers

NCT06570564

16122022

Details and patient eligibility

About

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.

Full description

1. 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):

   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.

2. Equipment:

Measurement equipment:

1. The Treadmill:

   All patients were tested Maximum walking distance and Pain free walking distance by walking in the treadmill.

2. Ankle/brachial indices (ABI) Doppler Ultrasound Machine

3. All patients were tested HbA1C before and after the treatment in medical analysis lab department at Damanhour Medical National Institute (DMNI).

Therapeutic equipment:

1. The arm crank ergometer
2. bicycle ergometer

Enrollment: 60 patients

Sex: All

Ages: 45 to 55 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Upper limb exercises group.

Experimental group

Description:

Upper limb exercises group consist of 20 patients. They received arm cranking exercise and routine physiotherapy program.

Treatment:

Device: The arm crank ergometer

Device: treadmill

Lower limb exercises group.

Experimental group

Description:

Lower limb exercises group consist of 20 patients. They received bicycling exercise and routine physiotherapy program.

Treatment:

Device: bicycle ergometer

Device: treadmill

The control group.

Experimental group

Description:

The control group consisted of 20 patients. They received only routine physiotherapy program.

Treatment:

Device: treadmill