Upper Versus Lower Limb Exercises on Intermittent Claudication in Diabetic Patients

NCT06570564 | Completed

• 1 other identifier: 16122022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Claudication

Outcome Measures

Primary Outcomes (5)

• maximum walking distance (MWD) in meter

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

  three consecutive months

• pain free walking distance (PFWD) in meter

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

  three consecutive months

• claudication score

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

  three consecutive months

• Ankle/brachial indices (ABI) by doppler ultrasound

  three consecutive months

• glycated haemoglobin (HbA1C)

  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

  three consecutive months

Study Arms (3)

Upper limb exercises group.

EXPERIMENTAL

Upper limb exercises group consist of 20 patients. They received arm cranking exercise and routine physiotherapy program.

Device: The arm crank ergometer; Device: treadmill

Lower limb exercises group.

EXPERIMENTAL

Lower limb exercises group consist of 20 patients. They received bicycling exercise and routine physiotherapy program.

Device: bicycle ergometer; Device: treadmill

The control group.

EXPERIMENTAL

The control group consisted of 20 patients. They received only routine physiotherapy program.

Device: treadmill

Interventions

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

Upper limb exercises group.

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)

Lower limb exercises group.

treadmill DEVICE

Supervised treadmill exercise as routine physiotherapy program

Lower limb exercises group.; The control group.; Upper limb exercises group.

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Damanhour teaching hospital

Damanhūr, Damanhour, Egypt

Location

MeSH Terms

Conditions

Intermittent Claudication

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: August 26, 2024
• Study Start: February 20, 2023
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)