Peripheral Artery DiseaseGrEnADaNCT02878954
Exercise in Peripheral Artery Disease
A study testing Exercise session in people with Peripheral Artery Disease and Intermittent Claudication, run by KU Leuven.
Trial summary
This research project aims to investigate the gender-based difference in patients with peripheral artery disease. To attend this, this study has two specific objectives: Objective 1: To identify gender-specific barriers towards exercise and physical activity in patients with peripheral artery disease (PAD). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Peripheral Artery Disease, Intermittent Claudication
- What is being tested?
- Exercise session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2019
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ankle-brachial index (ABI) ≤ 0.9 in one or two legs
- Fontaine stage II of PAD
- Body mass index <35 kg/m2
- Resting systolic blood pressure (BP) <160 mmHg and diastolic BP <105 mmHg
- Ability to walk at least 2min at 3.2 km/h
- Ability to undertake an incremental treadmill test
- Decrease of at least 15% in ABI after a maximal treadmill test
- Not currently engaging in any regular exercise program
Who cannot join
- Exercise induced signs of myocardial ischemia or complex ventricular arrhythmias
- Cardiovascular autonomic neuropathy
- Use of beta-blocker
- Nondihydropyridine calcium antagonists or insulin and hormone replacement therapy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Exercise in Peripheral Artery Disease - Gender-specific Differences and Unexplored Opportunities in Women: the GrEnADa-project
This research project aims to investigate the gender-based difference in patients with peripheral artery disease. To attend this, this study has two specific objectives:
Objective 1: To identify gender-specific barriers towards exercise and physical activity in patients with peripheral artery disease (PAD).
Objective 2: To evaluate gender-specific differences in functional capacity and cardiovascular function and regulation in patients with PAD at rest, during and following a single session of maximal exercise.
- Being tested
- No intervention (Observational study), Control session, Exercise session
- 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.
No intervention (Observational study)Other
160 patients will be recruited to:
- Fill in questionnaires related to demographic characteristics, severity of disease and physical activity.
- Perform a six-minute walk test Comparison between men and women will be performed.
Control sessionOther
Out of the 160 participants of the observational study, at least 40 (20 men and 20 women) will be recruited.
In the control session participants will be seated in resting position for 15 minutes.
Exercise sessionOther
40 patients will perform a single maximal exercise test on a treadmill. Speed will be maintained at 3.2 km/h and the grade will be increased with 2% every 2 min following Gardner's protocol.
| Study group | Role | What they receive |
|---|---|---|
| No intervention | Other | 160 men and women with PAD will be recruited. Receives: Other: No intervention (Observational study); Other: Control session; Other: Exercise session |
| Control session | Other | 40 patients (men and women) will complete this session. Receives: Other: Control session |
| Exercise session | Other | 40 patients (men and women) will complete this session. Receives: Other: Exercise session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barriers towards exercise assessed by questionnaires in patients with peripheral artery disease.
After completion of the 6-minute walking test, patients will be asked to fill in the following questionnaires: walking impairment questionnaire, walking estimated-limitation calculated by history (WELCH), San Diego Claudication Questionnaire, SF-36 and two questionnaires for personal and environmental barriers to physical activity.
Measured: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Gender-specific differences in walk capacity in patients with peripheral artery disease
The measurements of this outcome will be performed in a second visit day, separated by at least 48h from visit 1 (outcome 1).
Patients will perform a maximal exercise test to determine claudication onset distance (m) defined as the distance walked until the patients first reported pain in the leg during the treadmill test and total walk distance (m) defined as the total distance that the patient was able to walk during the test.
Measured: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Gender-specific differences in functional capacity in patients with peripheral artery disease
Walking economy defined as VO2 measured during the first stage of the treadmill test and functional capacity defined as VO2 peak obtained during the test will be obtained.
Measured: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Secondary outcomes (3)
Gender-specific differences in physical activity level measured by accelerometer
Measured: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Gender-specific differences in autonomic modulation at rest and after a maximal exercise test
Autonomic modulation: assessed by spectral analysis of heart rate and systolic blood pressure variabilities. Heart rate (electrocardiogram) and beat-by-beat blood pressure (finometer) will be recorded for 10 min at a sample frequency of 500Hz/channel.
Measured: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Gender-specific differences in vascular function in patients with peripheral artery disease at rest and after a maximal exercise test
Blood flow and blood flow response after reactive hyperemia.
Measured: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startJan 2017
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Véronique Cornelissen, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878954
- Sponsor's protocol ID
- 13072016_Grenada
- Acronym
- GrEnADa
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise in Peripheral Artery Disease - Gender-specific Differences and Unexplored Opportunities in Women: the GrEnADa-project
- ClinicalTrials.gov ID
- NCT02878954
- Acronym / sponsor ID
- GrEnADa / 13072016_Grenada
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 25 Aug 2016 (estimated)
- 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.
This research project aims to investigate the gender-based difference in patients with peripheral artery disease. To attend this, this study has two specific objectives:
Objective 1: To identify gender-specific barriers towards exercise and physical activity in patients with peripheral artery disease (PAD).
Objective 2: To evaluate gender-specific differences in functional capacity and cardiovascular function and regulation in patients with PAD at rest, during and following a single session of maximal exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No intervention | Other | Other: No intervention (Observational study), Other: Control session, Other: Exercise session160 men and women with PAD will be recruited. |
| Control session | Other | Other: Control session40 patients (men and women) will complete this session. |
| Exercise session | Other | Other: Exercise session40 patients (men and women) will complete this session. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ankle-brachial index (ABI) ≤ 0.9 in one or two legs
- Fontaine stage II of PAD
- Body mass index <35 kg/m2
- Resting systolic blood pressure (BP) <160 mmHg and diastolic BP <105 mmHg
- Ability to walk at least 2min at 3.2 km/h
Key exclusion criteria (4 listed)
- Exercise induced signs of myocardial ischemia or complex ventricular arrhythmias
- Cardiovascular autonomic neuropathy
- Use of beta-blocker
- Nondihydropyridine calcium antagonists or insulin and hormone replacement therapy
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 |
|---|---|---|
| No intervention (Observational study)160 patients will be recruited to: * Fill in questionnaires related to demographic characteristics, severity of disease and physical activity. * Perform a six-minute walk test Comparison between men and women will be performed. | Other | No intervention |
| Control sessionOut of the 160 participants of the observational study, at least 40 (20 men and 20 women) will be recruited. In the control session participants will be seated in resting position for 15 minutes. | Other | Control session, No intervention |
| Exercise session40 patients will perform a single maximal exercise test on a treadmill. Speed will be maintained at 3.2 km/h and the grade will be increased with 2% every 2 min following Gardner's protocol. | Other | Exercise session, No intervention |
Primary outcome
Barriers towards exercise assessed by questionnaires in patients with peripheral artery disease.
Time frame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
After completion of the 6-minute walking test, patients will be asked to fill in the following questionnaires: walking impairment questionnaire, walking estimated-limitation calculated by history (WELCH), San Diego Claudication Questionnaire, SF-36 and two questionnaires for personal and environmental barriers to physical activity.
Gender-specific differences in walk capacity in patients with peripheral artery disease
Time frame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
The measurements of this outcome will be performed in a second visit day, separated by at least 48h from visit 1 (outcome 1). Patients will perform a maximal exercise test to determine claudication onset distance (m) defined as the distance walked until the patients first reported pain in the leg during the treadmill test and total walk distance (m) defined as the total distance that the patient was able to walk during the test.
Gender-specific differences in functional capacity in patients with peripheral artery disease
Time frame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Walking economy defined as VO2 measured during the first stage of the treadmill test and functional capacity defined as VO2 peak obtained during the test will be obtained.
3 secondary outcomes
Gender-specific differences in physical activity level measured by accelerometer
Time frame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Gender-specific differences in autonomic modulation at rest and after a maximal exercise test
Time frame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Gender-specific differences in vascular function in patients with peripheral artery disease at rest and after a maximal exercise test
Time frame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise session in people with Peripheral Artery Disease and Intermittent Claudication, run by KU Leuven.
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 8 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: status not confirmed, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veronique Cornelissen, PhD (003216329152, veronique.cornelissen@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barriers towards exercise assessed by questionnaires in patients with peripheral artery disease. (time frame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.). The study lists 3 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 25 Aug 2016.