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Completed

NCT Number: NCT06570564

Upper Versus Lower Limb Exercises on Intermittent Claudication in Diabetic Patients

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.

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Key information

Age range

45 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damanhour teaching hospital

Damanhūr, Damanhour, Egypt

About this study

  • 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.

  • Equipment:

Measurement equipment:

  • The Treadmill:

All patients were tested Maximum walking distance and Pain free walking distance by walking in the treadmill.

  • Ankle/brachial indices (ABI) Doppler Ultrasound Machine
  • All patients were tested HbA1C before and after the treatment in medical analysis lab department at Damanhour Medical National Institute (DMNI).

Therapeutic equipment:

  • The arm crank ergometer
  • bicycle ergometer

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

The arm crank ergometer

Device

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

Device

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

Device

Supervised treadmill exercise as routine physiotherapy program

Primary outcomes

  1. maximum walking distance (MWD) in meter

    Time frame: three consecutive months

    the distance that had been walked on the treadmill when patients were unable to continue because of severe claudication pain

  2. pain free walking distance (PFWD) in meter

    Time frame: three consecutive months

    the distance that patients can walk on the treadmill before claudication pain begins

  3. claudication score

    Time frame: three consecutive months

    Claudication pain scale is a continuous scale from 1, indicating no pain, to 5 indicating severe pain

  4. Ankle/brachial indices (ABI) by doppler ultrasound

    Time frame: three consecutive months

  5. glycated haemoglobin (HbA1C)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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