Intermittent Claudication
Conditions
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
Interventions
DEVICEThe 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
DEVICEbicycle 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)
DEVICEtreadmill
Supervised treadmill exercise as routine physiotherapy program
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 55 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 |
Countries
Egypt
Outcome results
None listed