NCT06570564

Upper Versus Lower Limb Exercises on Intermittent Claudication in Diabetic Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 45 Years – 55 Years
• Healthy volunteers: Not accepted

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

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

Conditions

• Intermittent Claudication

Interventions

Type	Name	Description
DEVICE	The arm crank ergometer	Before starting the program, patients will perform an adaptation session for familiarization with the ergometer and also to identify the training load. For this, patients will perform 10 bouts of two minutes of exercising with a minimum load and two minute passive intervals between bouts. Patients will be instructed to maintain 50 revolutions per minute (RPM) during the exercise. Subsequently, to determine the training load for each session, patients will perform a progressive test where the load will be increased by 10 watts every minute of the test, following the protocol of two minutes of exercise with two minutes of interval
DEVICE	bicycle ergometer	bicycle ergometer program will consist of a bicycling exercise 3 days per week. Exercise intensity was set at 70% of maximal load with 30 minutes per session. The exercise protocol also incorporated warm-up and cool-down sessions that involved stretches of the major lower limb muscle groups (total exercise time, 40-60 minutes)
DEVICE	treadmill	Supervised treadmill exercise as routine physiotherapy program

Timeline

• Start date: 2023-02-20
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2024-08-26
• Last updated: 2024-08-26

Locations

1 site across 1 country: Egypt