Upper Versus Lower Limb Exercises on Intermittent Claudication in Diabetic Patients
NCT ID: NCT06570564
Last Updated: 2024-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2023-02-20
2024-02-20
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Upper limb exercises group.
Upper limb exercises group consist of 20 patients. They received arm cranking exercise and routine physiotherapy program.
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
treadmill
Supervised treadmill exercise as routine physiotherapy program
Lower limb exercises group.
Lower limb exercises group consist of 20 patients. They received bicycling exercise and routine physiotherapy program.
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)
treadmill
Supervised treadmill exercise as routine physiotherapy program
The control group.
The control group consisted of 20 patients. They received only routine physiotherapy program.
treadmill
Supervised treadmill exercise as routine physiotherapy program
Interventions
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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
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)
treadmill
Supervised treadmill exercise as routine physiotherapy program
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
45 Years
55 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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El-Sayed Essam
principle investigator
Locations
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Damanhour teaching hospital
Damanhūr, Damanhour, Egypt
Countries
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Other Identifiers
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16122022
Identifier Type: -
Identifier Source: org_study_id
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