Clinical trial NCT06570564: Upper Versus Lower Limb Exercises on Intermittent Claudication in Diabetic Patients
Official title: Upper Versus Lower Limb Exercises on Intermittent Claudication in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Claudication
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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).

Primary outcomes:
measure: maximum walking distance (MWD) in meter
timeFrame: three consecutive months
measure: pain free walking distance (PFWD) in meter
timeFrame: three consecutive months
measure: claudication score
timeFrame: three consecutive months
measure: Ankle/brachial indices (ABI) by doppler ultrasound
timeFrame: three consecutive months
measure: glycated haemoglobin (HbA1C)
timeFrame: three consecutive months
Secondary outcomes:
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour teaching hospital
state: Damanhour
Study officials:
References: