Peripheral Arterial DiseaseNCT05126680
Moderate Intensity Functional Training as Adjuvant Treatment in Patients With Peripheral Arterial Disease
A study testing Supervised exercise therapy: intermittent treadmill walking exercise and moderate intensity functional training and Supervised exercise therapy: intermittent treadmill walking exercise in people with Peripheral Arterial Disease and Intermittent Claudication, run by European University Miguel de Cervantes at 1 site in Spain.
Trial summary
Traditional aerobic training and muscle resistance ('strength') training have been shown to be effective for improving functional and health-related quality of life (HRQoL) outcomes in peripheral arterial disease (PAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Intermittent Claudication
- What is being tested?
- Supervised exercise therapy: intermittent treadmill walking exercise and moderate intensity functional training and Supervised exercise therapy: intermittent treadmill walking exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 19 Nov 2021to 30 Jun 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with PAD in grade IIa (Leriche-Fontaine Classification).
Who cannot join
- Subjects with dementia.
- Institutionalized Subjects in social health centers.
- Subjects with recent major surgery in the last year or lower limb amputations.
- Subjects with revascularization surgery of the lower extremities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vascular-Fit: Efficacy of an In-hospital Physical Exercise Program on Functional Capacity and Quality of Life in Patients With Peripheral Artery Disease
Traditional aerobic training and muscle resistance ('strength') training have been shown to be effective for improving functional and health-related quality of life (HRQoL) outcomes in peripheral arterial disease (PAD). However, the transfer of the current resistance exercise modes proposed to other activities of daily living (ADLs) is questionable. Moderate intensity functional training (MIFT) has emerged with the aim of achieving cardiovascular and neuromuscular adaptations simultaneously with functional exercises typical of ADLs. The effect of MIFT in patients with PAD is not yet known. Our purpose is to verify the influence of the combination of intermittent treadmill walking exercise with MIFT compared with intermittent treadmill walking exercise on functional capacity, HRQoL, biochemical and hemodynamic parameters in patients with PAD.
- Being tested
- Supervised exercise therapy: intermittent treadmill walking exercise and moderate intensity functional training, Supervised exercise therapy: intermittent treadmill walking exercise
- Keywords
- Peripheral arterial disease, Supervised exercise therapy, Functional training, Intermittent claudication
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise therapy: intermittent treadmill walking exercise and moderate intensity functional trainingOther
Subjects will perform a 12-week supervised exercise therapy program based on intermittent treadmill walking exercise (15-30 min.) and moderate intensity functional training (MIFT) (15 min.). In intermittent treadmill walking exercise, the speed and incline of treadmill will be adjusted that patients achieve moderate claudication pain in the time interval between 3 and 5 min. In MIFT, subjects must complete in 15 min. the highest number of repetitions / rounds possible (AMRAP) to a circuit composed of 6 global functional exercises from which they performed 10 repetitions with a rating of perceived exertion (RPE) of 5-7 on a 1 to 10 scale in each exercise.
Supervised exercise therapy: intermittent treadmill walking exerciseOther
Subjects will perform a 12-week supervised exercise therapy program based on intermittent treadmill walking exercise (30-45 min.). In intermittent treadmill walking exercise, the speed and incline of treadmill will be adjusted that patients achieve moderate claudication pain in the time interval between 3 and 5 min.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent treadmill walking exercise and moderate intensity functional training | Experimental | Subjects belonging to this group perform a 12-week supervised exercise therapy consisted of intermittent treadmill walking exercise and moderate intensity functional training. Receives: Other: Supervised exercise therapy: intermittent treadmill walking exercise and moderate intensity functional training |
| Intermittent treadmill walking exercise | Active comparator | Subjects belonging to this group perform a 12-week supervised exercise therapy consisted of intermittent treadmill walking exercise. Receives: Other: Supervised exercise therapy: intermittent treadmill walking exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-Minute Walk Test
Changes in maximum walking distance (MWD) and claudication onset distance (COD).
Measured: 0 weeks, 6 weeks and 12 weeks.
Moderate intensity functional training Test
Changes in number of rounds/repetitions and total workload.
Measured: 0 weeks, 6 weeks and 12 weeks.
Short Form-36 Health Survey (SF-36)
Changes in the eight domains of health status.
Measured: 0 weeks, 6 weeks and 12 weeks.
Vascular Quality of Life Questionnaire-6 (VascuQol-6)
Changes in total punctuation of questionnaire.
Measured: 0 weeks, 6 weeks and 12 weeks.
Secondary outcomes (10)
Biochemical analysis
Changes in complete lipid profile
Measured: 0 weeks, 6 weeks and 12 weeks.
Biochemical analysis
Changes in lactate dehydrogenase
Measured: 0 weeks, 6 weeks and 12 weeks.
Biochemical analysis
Changes in c-reactive protein
Measured: 0 weeks, 6 weeks and 12 weeks.
Biochemical analysis
Changes in tumor necrosis factor alpha
Measured: 0 weeks, 6 weeks and 12 weeks.
Biochemical analysis
Changes in serum apolipoproteins
Measured: 0 weeks, 6 weeks and 12 weeks.
Biochemical analysis
Analysis of the complete oxidative profile
Measured: 0 weeks, 6 weeks and 12 weeks.
Hemodynamic measurements
Changes in mean, systolic and diastolic blood pressure.
Measured: 0 weeks, 6 weeks and 12 weeks.
Hemodynamic measurements
Changes in flow-mediated dilation of the brachial artery
Measured: 0 weeks, 6 weeks and 12 weeks.
Hemodynamic measurements
Changes in ankle-brachial index
Measured: 0 weeks, 6 weeks and 12 weeks.
Hemodynamic measurements
Changes in pulse wave velocity
Measured: 0 weeks, 6 weeks and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start19 Nov 2021
- Primary completion30 Apr 2023
- Study completion30 Jun 2023
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University Miguel de Cervantes
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valladolid
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126680
- Sponsor's protocol ID
- PI-DOC001-PAD
- Status last verified
- Jan 2024
- First submitted
- 8 Nov 2021
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Penin-Grandes S, Lopez-Ortiz S, de la Fuente Gomez M, Pinto-Fraga J, Lista S, Maroto-Izquierdo S, Lucia A, Del Rio Sola ML, Martin-Hernandez J, Santos-Lozano A. Move Better, Live Better: A Novel Supervised Combined Training for Peripheral Arterial Disease: A Quasi-experimental Approach. Am J Phys Med Rehabil. 2025 Sep 1;104(9):771-779. doi: 10.1097/PHM.0000000000002706. Epub 2025 Jan 6.
PubMed 39792377
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular-Fit: Efficacy of an In-hospital Physical Exercise Program on Functional Capacity and Quality of Life in Patients With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT05126680
- Acronym / sponsor ID
- PI-DOC001-PAD
- Keywords
- Peripheral arterial disease, Supervised exercise therapy, Functional training, Intermittent claudication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- European University Miguel de CervantesUniversity, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valladolid
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Nov 2021 (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.
Traditional aerobic training and muscle resistance ('strength') training have been shown to be effective for improving functional and health-related quality of life (HRQoL) outcomes in peripheral arterial disease (PAD). However, the transfer of the current resistance exercise modes proposed to other activities of daily living (ADLs) is questionable. Moderate intensity functional training (MIFT) has emerged with the aim of achieving cardiovascular and neuromuscular adaptations simultaneously with functional exercises typical of ADLs. The effect of MIFT in patients with PAD is not yet known. Our purpose is to verify the influence of the combination of intermittent treadmill walking exercise with MIFT compared with intermittent treadmill walking exercise on functional capacity, HRQoL, biochemical and hemodynamic parameters in patients with PAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent treadmill walking exercise and moderate intensity functional training | Experimental | Other: Supervised exercise therapy: intermittent treadmill walking exercise and moderate intensity functional trainingSubjects belonging to this group perform a 12-week supervised exercise therapy consisted of intermittent treadmill walking exercise and moderate intensity functional training. |
| Intermittent treadmill walking exercise | Active comparator | Other: Supervised exercise therapy: intermittent treadmill walking exerciseSubjects belonging to this group perform a 12-week supervised exercise therapy consisted of intermittent treadmill walking exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with PAD in grade IIa (Leriche-Fontaine Classification).
Key exclusion criteria (4 listed)
- Subjects with dementia.
- Institutionalized Subjects in social health centers.
- Subjects with recent major surgery in the last year or lower limb amputations.
- Subjects with revascularization surgery of the lower extremities.
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 |
|---|---|---|
| Supervised exercise therapy: intermittent treadmill walking exercise and moderate intensity functional trainingSubjects will perform a 12-week supervised exercise therapy program based on intermittent treadmill walking exercise (15-30 min.) and moderate intensity functional training (MIFT) (15 min.). In intermittent treadmill walking exercise, the speed and incline of treadmill will be adjusted that patients achieve moderate claudication pain in the time interval between 3 and 5 min. In MIFT, subjects must complete in 15 min. the highest number of repetitions / rounds possible (AMRAP) to a circuit composed of 6 global functional exercises from which they performed 10 repetitions with a rating of perceived exertion (RPE) of 5-7 on a 1 to 10 scale in each exercise. | Other | Intermittent treadmill walking exercise and moderate intensity functional training |
| Supervised exercise therapy: intermittent treadmill walking exerciseSubjects will perform a 12-week supervised exercise therapy program based on intermittent treadmill walking exercise (30-45 min.). In intermittent treadmill walking exercise, the speed and incline of treadmill will be adjusted that patients achieve moderate claudication pain in the time interval between 3 and 5 min. | Other | Intermittent treadmill walking exercise |
Primary outcome
Six-Minute Walk Test
Time frame: 0 weeks, 6 weeks and 12 weeks.
Changes in maximum walking distance (MWD) and claudication onset distance (COD).
Moderate intensity functional training Test
Time frame: 0 weeks, 6 weeks and 12 weeks.
Changes in number of rounds/repetitions and total workload.
Short Form-36 Health Survey (SF-36)
Time frame: 0 weeks, 6 weeks and 12 weeks.
Changes in the eight domains of health status.
Vascular Quality of Life Questionnaire-6 (VascuQol-6)
Time frame: 0 weeks, 6 weeks and 12 weeks.
Changes in total punctuation of questionnaire.
10 secondary outcomes
Biochemical analysis
Time frame: 0 weeks, 6 weeks and 12 weeks.
Biochemical analysis
Time frame: 0 weeks, 6 weeks and 12 weeks.
Biochemical analysis
Time frame: 0 weeks, 6 weeks and 12 weeks.
Biochemical analysis
Time frame: 0 weeks, 6 weeks and 12 weeks.
Biochemical analysis
Time frame: 0 weeks, 6 weeks and 12 weeks.
Biochemical analysis
Time frame: 0 weeks, 6 weeks and 12 weeks.
Hemodynamic measurements
Time frame: 0 weeks, 6 weeks and 12 weeks.
Hemodynamic measurements
Time frame: 0 weeks, 6 weeks and 12 weeks.
Hemodynamic measurements
Time frame: 0 weeks, 6 weeks and 12 weeks.
Hemodynamic measurements
Time frame: 0 weeks, 6 weeks and 12 weeks.
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 11 Jan 2024.
- Derived from this study: PubMed 39792377Penin-Grandes S, Lopez-Ortiz S, de la Fuente Gomez M, Pinto-Fraga J, Lista S, Maroto-Izquierdo S, Lucia A, Del Rio Sola ML, Martin-Hernandez J, Santos-Lozano A. Move Better, Live Better: A Novel Supervised Combined Training for Peripheral Arterial Disease: A Quasi-experimental Approach. Am J Phys Med Rehabil. 2025 Sep 1;104(9):771-779. doi: 10.1097/PHM.0000000000002706. Epub 2025 Jan 6.
- 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 Supervised exercise therapy: intermittent treadmill walking exercise and moderate intensity functional training and Supervised exercise therapy: intermittent treadmill walking exercise in people with Peripheral Arterial Disease and Intermittent Claudication, run by European University Miguel de Cervantes at 1 site in Spain.
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 1 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 11 Jan 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 Spain. 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?
Six-Minute Walk Test (time frame: 0 weeks, 6 weeks and 12 weeks.). The study lists 4 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 NCT05126680, 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 11 Jan 2024.