Intermittent ClaudicationNCT06570564
Upper Versus Lower Limb Exercises on Intermittent Claudication in Diabetic Patients
A study testing The arm crank ergometer, bicycle ergometer and treadmill in people with Intermittent Claudication, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 55 years
- Conditions the study is for
- Intermittent Claudication
- What is being tested?
- The arm crank ergometer, bicycle ergometer and treadmill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2023to 20 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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):
Read more
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.
Read the detailed description
- 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
- Conditions
- Intermittent Claudication
- Being tested
- The arm crank ergometer, bicycle ergometer, treadmill
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The arm crank ergometerDevice
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 ergometerDevice
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)
treadmillDevice
Supervised treadmill exercise as routine physiotherapy program
| Study group | Role | What they receive |
|---|---|---|
| Upper limb exercises group. | Experimental | Upper limb exercises group consist of 20 patients. They received arm cranking exercise and routine physiotherapy program. Receives: 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. Receives: Device: bicycle ergometer; Device: treadmill |
| The control group. | Experimental | The control group consisted of 20 patients. They received only routine physiotherapy program. Receives: Device: treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: three consecutive months
pain free walking distance (PFWD) in meter
the distance that patients can walk on the treadmill before claudication pain begins
Measured: three consecutive months
claudication score
Claudication pain scale is a continuous scale from 1, indicating no pain, to 5 indicating severe pain
Measured: three consecutive months
Ankle/brachial indices (ABI) by doppler ultrasound
Measured: 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
Measured: three consecutive months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start20 Feb 2023
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, El-Sayed Essam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570564
- Sponsor's protocol ID
- 16122022
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Versus Lower Limb Exercises on Intermittent Claudication in Diabetic Patients
- ClinicalTrials.gov ID
- NCT06570564
- Acronym / sponsor ID
- 16122022
- Conditions
- Intermittent Claudication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Upper limb exercises group. | Experimental | Device: The arm crank ergometer, Device: treadmillUpper limb exercises group consist of 20 patients. They received arm cranking exercise and routine physiotherapy program. |
| Lower limb exercises group. | Experimental | Device: bicycle ergometer, Device: treadmillLower limb exercises group consist of 20 patients. They received bicycling exercise and routine physiotherapy program. |
| The control group. | Experimental | Device: treadmillThe control group consisted of 20 patients. They received only routine physiotherapy program. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The arm crank ergometerBefore 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 | Device | Upper limb exercises group. |
| bicycle ergometerbicycle 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) | Device | Lower limb exercises group. |
| treadmillSupervised treadmill exercise as routine physiotherapy program | Device | Lower limb exercises group., The control group., Upper limb exercises group. |
Primary outcome
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
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
claudication score
Time frame: 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
Time frame: three consecutive months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Intermittent Claudication
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The arm crank ergometer, bicycle ergometer and treadmill in people with Intermittent Claudication, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum walking distance (MWD) in meter (time frame: three consecutive months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.