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Trial record 15 of 30 for:    Recruiting, Not yet recruiting, Available Studies | "Intermittent Claudication"

Exercise in Peripheral Artery Disease (GrEnADa)

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ClinicalTrials.gov Identifier: NCT02878954
Recruitment Status : Not yet recruiting
First Posted : August 25, 2016
Last Update Posted : August 25, 2016
Sponsor:
Information provided by (Responsible Party):
Véronique Cornelissen, Katholieke Universiteit Leuven

Brief 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).

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.


Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Intermittent Claudication Other: No intervention (Observational study) Other: Control session Other: Exercise session Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise in Peripheral Artery Disease - Gender-specific Differences and Unexplored Opportunities in Women: the GrEnADa-project
Study Start Date : January 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No intervention
160 men and women with PAD will be recruited.
Other: 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: 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.


Other: 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.
Other: 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.
Other: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.


Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
    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.

  3. 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. ]
    Blood flow and blood flow response after reactive hyperemia.



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02878954


Contacts
Contact: Veronique Cornelissen, PhD 003216329152 veronique.cornelissen@kuleuven.be

Sponsors and Collaborators
Katholieke Universiteit Leuven

Responsible Party: Véronique Cornelissen, PhD, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT02878954     History of Changes
Other Study ID Numbers: 13072016_Grenada
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Peripheral Arterial Disease
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Signs and Symptoms