Peripheral Artery DiseaseGrEnADaNCT02879019
Walking Training in Peripheral Artery Disease (GrEnADa Sub-study)
A study testing Stretching exercise group and Walking training group in people with Peripheral Artery Disease and Intermittent Claudication, run by KU Leuven.
Trial summary
Whereas the efficacy of exercise interventions has been abundantly proven in male with peripheral artery disease (PAD), it remains to be determined whether these interventions are effective in women. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women only
- Conditions the study is for
- Peripheral Artery Disease, Intermittent Claudication
- What is being tested?
- Stretching exercise group and Walking training group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2017to Oct 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aankle-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.
About this study
Official title: 12 Weeks of Walking Exercise Training in Women With Peripheral Artery Disease: A Sub-study of GrEnADa-project
Whereas the efficacy of exercise interventions has been abundantly proven in male with peripheral artery disease (PAD), it remains to be determined whether these interventions are effective in women. The aim of this randomized controlled trial which will be performed with 34 PAD women will be to investigating the effects of 12 weeks of supervised walking on functional capacity and cardiovascular function and regulation at rest and during exercise.
- Being tested
- Stretching exercise group, Walking training group
- 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.
Stretching exercise groupOther
In each stretching class, approximately 20 exercises will be performed. The total duration of the session will be approximately 30 minutes.
Walking training groupOther
Patients will perform two walking session per week, each consisting of 15*2-min walking bouts, with 2-min of rest in between. The intensity will be set at heart rate corresponding to the pain threshold.
| Study group | Role | What they receive |
|---|---|---|
| Stretching exercise group | Sham comparator | Patients will receive two session per week of stretching classes. Receives: Other: Stretching exercise group |
| Walking training group | Experimental | Patients will perform two walking sessions per week. Receives: Other: Walking training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in walking capacity at 12 weeks of follow-up
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 will be performed before and after 12 weeks of follow-up.
Measured: 12 weeks
Change in functional capacity at 12 weeks of follow-up
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 measured to determine the cardiopulmonary response after 12 weeks of walking training.
Measured: 12 weeks
Change in heart rate pain threshold at 12 weeks of follow-up
The heart rate obtained at claudication onset distance during the treadmill test will be evaluate before and after 12 weeks of follow-up.
Measured: 12 weeks
Secondary outcomes (5)
Change in Ankle-Brachial Index decrease at 12 weeks of follow-up
Will defined by the difference in ankle-brachial index measured immediately after the exercise and pre-exercise.
Measured: 12 weeks
Change in ischemic window at 12 weeks of follow-up
Calculated by area under the curve of the ankle systolic blood pressure measured during the first 10 min of recovery after the test divided by total walk distance.
Measured: 12 weeks
Change in autonomic modulation at 12 weeks of follow-up
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: 12 weeks
Change in cardiac output at 12 weeks of follow-up
Cardiac output will be estimated at baseline and after 12 weeks of follow-up bu the indirect Fick method using the CO2 rebreathing technique and a metabolic card.
Measured: 12 weeks
Change in vascular function at 12 weeks of follow-up
Blood flow and blood flow in response to hyperemia will be obtained.
Measured: 12 weeks
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 startNov 2017 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionOct 2019 (estimated)
Why it stopped: Study was not started due to lack of funding
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
- 0 participants (actual)
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
- NCT02879019
- Sponsor's protocol ID
- 150716_GrenSub
- Acronym
- GrEnADa
- Status last verified
- Jun 2019
- First submitted
- 11 Aug 2016
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12 Weeks of Walking Exercise Training in Women With Peripheral Artery Disease: A Sub-study of GrEnADa-project
- ClinicalTrials.gov ID
- NCT02879019
- Acronym / sponsor ID
- GrEnADa / 150716_GrenSub
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not started due to lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Oct 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.
Whereas the efficacy of exercise interventions has been abundantly proven in male with peripheral artery disease (PAD), it remains to be determined whether these interventions are effective in women. The aim of this randomized controlled trial which will be performed with 34 PAD women will be to investigating the effects of 12 weeks of supervised walking on functional capacity and cardiovascular function and regulation at rest and during exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stretching exercise group | Sham comparator | Other: Stretching exercise groupPatients will receive two session per week of stretching classes. |
| Walking training group | Experimental | Other: Walking training groupPatients will perform two walking sessions per week. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- aankle-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 (3 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 |
|---|---|---|
| Stretching exercise groupIn each stretching class, approximately 20 exercises will be performed. The total duration of the session will be approximately 30 minutes. | Other | Stretching exercise group |
| Walking training groupPatients will perform two walking session per week, each consisting of 15*2-min walking bouts, with 2-min of rest in between. The intensity will be set at heart rate corresponding to the pain threshold. | Other | Walking training group |
Primary outcome
Change in walking capacity at 12 weeks of follow-up
Time frame: 12 weeks
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 will be performed before and after 12 weeks of follow-up.
Change in functional capacity at 12 weeks of follow-up
Time frame: 12 weeks
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 measured to determine the cardiopulmonary response after 12 weeks of walking training.
Change in heart rate pain threshold at 12 weeks of follow-up
Time frame: 12 weeks
The heart rate obtained at claudication onset distance during the treadmill test will be evaluate before and after 12 weeks of follow-up.
5 secondary outcomes
Change in Ankle-Brachial Index decrease at 12 weeks of follow-up
Time frame: 12 weeks
Change in ischemic window at 12 weeks of follow-up
Time frame: 12 weeks
Change in autonomic modulation at 12 weeks of follow-up
Time frame: 12 weeks
Change in cardiac output at 12 weeks of follow-up
Time frame: 12 weeks
Change in vascular function at 12 weeks of follow-up
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
Related trials for Peripheral Artery Disease
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching exercise group and Walking training group 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 3 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: withdrawn, as of the sponsor's last update on 24 Jun 2019. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in walking capacity at 12 weeks of follow-up (time frame: 12 weeks). 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 24 Jun 2019.