Peripheral Arterial DiseaseNCT04302571
Effects of Combined Aerobic and Resistance Training in Patients With Intermittent Claudication
A study testing combined aerobic and resistance physical activity in people with Peripheral Arterial Disease and Endothelial Dysfunction, run by University Of Perugia at 1 site in Italy.
Trial summary
Exercise training improves walking capacity and regional perfusion in patients with Intermittent Claudication (IC). Endothelial Progenitor Cells (EPCs) and Endothelial Microparticles (EMPs) could play an important role in this process, promoting the healing of the diseased endothelium. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease, Endothelial Dysfunction
- What is being tested?
- combined aerobic and resistance physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2020to Jan 2021
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- history of stable intermittent claudication (PAD, stage II Fontaine)
- resting ankle-brachial index (ABI) <0,9 and the presence of occlusion or significant stenosis at the color-Doppler duplex ultrasound scanning
Who cannot join
- lower-limb ischemic rest pain or gangrene (Fontaine stages III and IV)
- inability to obtain the ABI value or to perform a walking test
- exercise tolerance limited by factors other than claudication (i.e., arrhythmias, cardiac symptoms or exaggerated blood pressure rise, severe obesity)
- end-stage liver or renal failure
- acute or chronic inflammatory conditions
- history of recent (<6 months) acute coronary syndrome, cerebrovascular event or inducible myocardial ischemia
- treatment with drugs known to affect walking capacity, including calcium-channel blockers, β-blockers and angiotensin-converting enzyme inhibitors.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ospedale "Santa Maria della Misericordia" di Perugia
Perugia, PG, 06132
About this study
Official title: Effects of Home-based Combined Aerobic and Resistance Training on Walking Capacity, Circulating Endothelial Progenitor Cells AND Endothelial Function in Patients With Intermittent Claudication
Exercise training improves walking capacity and regional perfusion in patients with Intermittent Claudication (IC). Endothelial Progenitor Cells (EPCs) and Endothelial Microparticles (EMPs) could play an important role in this process, promoting the healing of the diseased endothelium.
The investigators are going to measure EPCs and EMPs in a group of patients with IC and in a control group of healthy individuals before a treadmill test and 2, 24, and 48 hours after the test. Subsequently, a group of IC patients will be randomly assigned to perform a 12-week home-based exercise training program.
The investigators expect a significant increase of EMPs and EPCs after acute and chronic physical activity. We expect also a correlation between the increase of EMPs and EPCs and the improvement in walking capacity. Aim of the study is to demonstrate that acutely performed aerobic exercise could be able to promote the mobilization of EMPs and EPCs in patients with IC and that endothelial progenitor cells mobilization could play a pivotal role in exercise induced improvement of walking performance and endothelial function in subjects with IC.
- Being tested
- combined aerobic and resistance physical activity, sham exercise
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined aerobic and resistance physical activityBehavioural
Five training sessions weekly for 12 weeks are scheduled. Each session lasts 60 minutes divided into 45 minutes of aerobic workout and 15 minutes of circuit training. The aerobic workout consists of walking on a flat floor or on a slight uphill (maximum slope 3%): patients should walk until submaximal walking capacity (80% of their MWT) and rest as they would experience pain at the lower limbs; afterwards, they should start to walk again, once the pain was improved. Resistance training consists of calisthenics exercises focused on trunk and lower limbs muscles (bicycle, flutter kicks, squats, lunges, calf raises, wall sits and power press) with at least 3 repetitions for each exercise, interspersed by 30 seconds recovery. Duration of repetitions increases every 3 weeks.
sham exerciseBehavioural
general recommendation to perform regular aerobic physical activity
| Study group | Role | What they receive |
|---|---|---|
| Healthy control | No intervention | Voluntary subjects without peripheral arterial disease |
| IC patients, no exercise | Sham comparator | Patients with peripheral arterial disease stage II (intermittent claudication) on best medical treatment, given advices to perform regular aerobic activity Receives: Behavioral: sham exercise |
| IC patients, exercise | Active comparator | Patients with peripheral arterial disease stage II (intermittent claudication) on best medical treatment, home-based combined physical exercise Receives: Behavioral: combined aerobic and resistance physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Microparticles (EMPs)
hematological parameter, cells particles released by activated endothelium, measured by cytofluorimetry
Measured: week 0 - week 12
Endothelial Progenitor Cells (EPCs)
hematological parameter, immature bone-marrow derived cells which repair the damaged endothelium, measured by cytofluorimetry
Measured: week 0 - week 12
Maximum Walking Time
functional parameter, maximum walking capacity for an individual with IC measured through a treadmill walking test
Measured: week 0 - week 12
Pain-free Walking Time
maximum walking capacity for an individual with IC without experiencing pain measured through a treadmill walking test
Measured: week 0 - week 12
Flow-mediated Dilation
ultrasonographic evaluation of endothelial function
Measured: week 0 - week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Mar 2020
- Primary completion31 Dec 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rita Lombardini, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302571
- Sponsor's protocol ID
- APE-IC1
- Status last verified
- Mar 2020
- First submitted
- 5 Mar 2020
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pasqualini L, Bagaglia F, Ministrini S, Frangione MR, Leli C, Siepi D, Lombardini R, Marini E, Naeimi Kararoudi M, Piratinskiy A, Pirro M. Effects of structured home-based exercise training on circulating endothelial progenitor cells and endothelial function in patients with intermittent claudication. Vasc Med. 2021 Dec;26(6):633-640. doi: 10.1177/1358863X211020822. Epub 2021 Jun 21.
PubMed 34151646
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home-based Combined Aerobic and Resistance Training on Walking Capacity, Circulating Endothelial Progenitor Cells AND Endothelial Function in Patients With Intermittent Claudication
- ClinicalTrials.gov ID
- NCT04302571
- Acronym / sponsor ID
- APE-IC1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 10 Mar 2020 (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.
Exercise training improves walking capacity and regional perfusion in patients with Intermittent Claudication (IC). Endothelial Progenitor Cells (EPCs) and Endothelial Microparticles (EMPs) could play an important role in this process, promoting the healing of the diseased endothelium.
The investigators are going to measure EPCs and EMPs in a group of patients with IC and in a control group of healthy individuals before a treadmill test and 2, 24, and 48 hours after the test. Subsequently, a group of IC patients will be randomly assigned to perform a 12-week home-based exercise training program.
The investigators expect a significant increase of EMPs and EPCs after acute and chronic physical activity. We expect also a correlation between the increase of EMPs and EPCs and the improvement in walking capacity. Aim of the study is to demonstrate that acutely performed aerobic exercise could be able to promote the mobilization of EMPs and EPCs in patients with IC and that endothelial progenitor cells mobilization could play a pivotal role in exercise induced improvement of walking performance and endothelial function in subjects with IC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control | No intervention | –Voluntary subjects without peripheral arterial disease |
| IC patients, no exercise | Sham comparator | Behavioral: sham exercisePatients with peripheral arterial disease stage II (intermittent claudication) on best medical treatment, given advices to perform regular aerobic activity |
| IC patients, exercise | Active comparator | Behavioral: combined aerobic and resistance physical activityPatients with peripheral arterial disease stage II (intermittent claudication) on best medical treatment, home-based combined physical exercise |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- history of stable intermittent claudication (PAD, stage II Fontaine)
- resting ankle-brachial index (ABI) <0,9 and the presence of occlusion or significant stenosis at the color-Doppler duplex ultrasound scanning
Key exclusion criteria (7 listed)
- lower-limb ischemic rest pain or gangrene (Fontaine stages III and IV)
- inability to obtain the ABI value or to perform a walking test
- exercise tolerance limited by factors other than claudication (i.e., arrhythmias, cardiac symptoms or exaggerated blood pressure rise, severe obesity)
- end-stage liver or renal failure
- acute or chronic inflammatory conditions
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 |
|---|---|---|
| combined aerobic and resistance physical activityFive training sessions weekly for 12 weeks are scheduled. Each session lasts 60 minutes divided into 45 minutes of aerobic workout and 15 minutes of circuit training. The aerobic workout consists of walking on a flat floor or on a slight uphill (maximum slope 3%): patients should walk until submaximal walking capacity (80% of their MWT) and rest as they would experience pain at the lower limbs; afterwards, they should start to walk again, once the pain was improved. Resistance training consists of calisthenics exercises focused on trunk and lower limbs muscles (bicycle, flutter kicks, squats, lunges, calf raises, wall sits and power press) with at least 3 repetitions for each exercise, interspersed by 30 seconds recovery. Duration of repetitions increases every 3 weeks. | Behavioural | IC patients, exercise |
| sham exercisegeneral recommendation to perform regular aerobic physical activity | Behavioural | IC patients, no exercise |
Primary outcome
Endothelial Microparticles (EMPs)
Time frame: week 0 - week 12
hematological parameter, cells particles released by activated endothelium, measured by cytofluorimetry
Endothelial Progenitor Cells (EPCs)
Time frame: week 0 - week 12
hematological parameter, immature bone-marrow derived cells which repair the damaged endothelium, measured by cytofluorimetry
Maximum Walking Time
Time frame: week 0 - week 12
functional parameter, maximum walking capacity for an individual with IC measured through a treadmill walking test
Pain-free Walking Time
Time frame: week 0 - week 12
maximum walking capacity for an individual with IC without experiencing pain measured through a treadmill walking test
Flow-mediated Dilation
Time frame: week 0 - week 12
ultrasonographic evaluation of endothelial function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Derived from this study: PubMed 34151646Pasqualini L, Bagaglia F, Ministrini S, Frangione MR, Leli C, Siepi D, Lombardini R, Marini E, Naeimi Kararoudi M, Piratinskiy A, Pirro M. Effects of structured home-based exercise training on circulating endothelial progenitor cells and endothelial function in patients with intermittent claudication. Vasc Med. 2021 Dec;26(6):633-640. doi: 10.1177/1358863X211020822. Epub 2021 Jun 21.
- Individual participant dataSharing planned: No
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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 combined aerobic and resistance physical activity in people with Peripheral Arterial Disease and Endothelial Dysfunction, run by University Of Perugia at 1 site in Italy.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Mar 2020. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Endothelial Microparticles (EMPs) (time frame: week 0 - week 12). 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?
On the ClinicalTrials.gov record for NCT04302571, which also lists 1 linked publication.
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 27 Mar 2020.