Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2017-01-31
2019-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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No intervention
160 men and women with PAD will be recruited.
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.
Control session
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 session
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.
Control session
40 patients (men and women) will complete this session.
Control session
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 session
40 patients (men and women) will complete this session.
Exercise session
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.
Interventions
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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.
Control session
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 session
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Cardiovascular autonomic neuropathy
* Use of beta-blocker
* Nondihydropyridine calcium antagonists or insulin and hormone replacement therapy
50 Years
80 Years
ALL
No
Sponsors
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KU Leuven
OTHER
Responsible Party
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Véronique Cornelissen
PhD
Central Contacts
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Other Identifiers
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13072016_Grenada
Identifier Type: -
Identifier Source: org_study_id
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