Upper Versus Lower Limb Exercises on Intermittent Claudication in Diabetic Patients

Not Applicable

Completed

• Conditions: Intermittent Claudication
• Interventions: Device: The arm crank ergometer; Device: bicycle ergometer; Device: treadmill

• Registration Number: NCT06570564
• Lead Sponsor: Cairo University

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

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

Study Timeline

• Study Start: 2023-02-20
• Primary Completion: 2024-02-20
• Study Completion: 2024-02-20
• Status Verified: 2024-04
• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-22
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Upper limb exercises group.	treadmill	Upper limb exercises group consist of 20 patients. They received arm cranking exercise and routine physiotherapy program.
The control group.	treadmill	The control group consisted of 20 patients. They received only routine physiotherapy program.
Upper limb exercises group.	The arm crank ergometer	Upper limb exercises group consist of 20 patients. They received arm cranking exercise and routine physiotherapy program.
Lower limb exercises group.	treadmill	Lower limb exercises group consist of 20 patients. They received bicycling exercise and routine physiotherapy program.
Lower limb exercises group.	bicycle ergometer	Lower limb exercises group consist of 20 patients. They received bicycling exercise and routine physiotherapy program.

Primary Outcome Measures

Name	Time	Method
glycated haemoglobin (HbA1C)	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	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	three consecutive months	the distance that patients can walk on the treadmill before claudication pain begins
claudication score	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	three consecutive months

Trial Locations

Locations (1)

Damanhour teaching hospital; 🇪🇬 Damanhūr, Damanhour, Egypt