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Home-based Exercise Therapy for Patients With PAD (WalkingPAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04749732
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : March 9, 2022
Sponsor:
Collaborators:
Foundation for Science and Technology, Portugal
University of Trás-os-Montes and Alto Douro
Institute for Systems and Computer Engineering, Technology and Science-INESC TEC
Information provided by (Responsible Party):
Ivone Silva, Centro Hospitalar do Porto

Brief Summary:
Cardiovascular disease represents a considerable economic burden to society and effective preventive measures are necessary. Patients with peripheral arterial disease (PAD) have a severe impairment of functional ability, namely in walking distance due to muscle ischemia defined as intermittent claudication (IC). The discomfort related to IC contributes to a sedentary lifestyle, decreasing physical fitness level, aggravating cardiovascular risk factors leading to disease deterioration. Exercise programs are an effective, low-cost, low-risk option compared with more invasive therapies for IC. Home-based exercise therapy (HBET) is structured, unsupervised, self-directed programs that take place in the personal setting of the patient rather than in a clinical setting. HBET program implementation is feasible and eliminates barriers such as transportation issues, proximity to clinics, and conflicts with occupational responsibilities. Even though these programs have shown to be effective at improving walking performance and distance, their results fall below those seen in Supervised Exercise Therapy (SET) programs. Thus, innovative home-based walking programs need to be developed in order to improve results and make exercise therapy available to a larger percentage of the population. The use of Information and communication technology (ICT) tools for self-monitoring is considered key to change long-term behavior. The WalkingPAD project aims to develop health technology assessment methods and evaluate personal health intervention strategies. Investigators intend to demonstrate the technical feasibility and economic viability of a personalized medicine application in real-life healthcare settings. This project intends to find evidence for three major questions: Does an M-health monitored home-based exercise program supported by a virtual assistant empowers commitment to exercise plan and allows remote control of plan accomplishment? Is it superior to an M-health monitored home-based exercise program supported by a behavioral motivational intervention, in increasing maximum walking distance? Is it superior to a self-monitoring exercise, with a specific self-designed walking plan in the residence area, in increasing maximum walking distance?

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease (PAD) Intermittent Claudication Behavioral: WalkingPad plus Psychological Intervention - PsyWPad Group Behavioral: WalkingPad plus Virtual Assistant - CyberWPad Group Behavioral: WalkingPad group - Paper WPad Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a single-center three-arm parallel prospective, randomized controlled and superiority trial, with stratified random allocation, aiming to test the effectiveness of a Home-based Exercise Therapy (HbET) for claudicant patients to increase the Maximum Walking Distance (MWD), the Pain-free Walking Distance (PFWD) and the Functional Walking Distance (FWD). Patients will be assigned to one of three groups: an active control group (ACG); an experimental group 1 (GE1) and an experimental group 2 (EG2). All groups will have in common the prescription of a walking plan on a route defined by one of the team members through WalkingPAD web-platform and customized to the patient's home area. Participants from all three groups will undergo standard treatment for PAD and IC, according to the guidelines of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.
Masking: Single (Outcomes Assessor)
Masking Description: Eligible participants will be randomly assigned to three groups in blocks of multiples of five and will be stratified according to i) age; and ii) mean walking distance at the baseline. This procedure will be performed using an online random number generator, by a researcher external to the team involved in the execution of this study, in order to ensure the concealment of the allocation of participants by the different groups. The participants will be blinded as to the group where they were allocated. After this procedure, it will not be possible to hide the group to which the patient belongs from the researcher who will carry out the psychological intervention and from the informatics engineer who will define the route of the walking plan. However, the outcome assessors (doctors, researchers, the clinical physiologist, and the exercise specialist) will be blinded to the allocation group.
Primary Purpose: Treatment
Official Title: Patient Education on a Quantified Supervised Home-based Exercise Therapy to Improve Walking Ability in Patients With Peripheral Arterial Disease and Intermittent Claudication: WalkingPad Protocol
Actual Study Start Date : February 9, 2021
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: WalkingPad plus Psychological Intervention - PsyWPad Group
The participants in Experimental Group 1 will receive a prescription of an HBET consisting of a walking plan with a duration greater than 30 min per session, frequency of at least three sessions per week, use of near-maximal pain during training as claudication pain endpoint, with the support of a behavioral motivational intervention delivered by a health psychologist.
Behavioral: WalkingPad plus Psychological Intervention - PsyWPad Group
The 24-week walking program will be monitored by the WalkingPAD application that will accompany the patient on their walks and record their adherence to the previously defined individual program. Motivational support for a behavioral intervention will include two face-to-face sessions and the following contacts will be made over the phone. The behavioral motivational intervention will follow the principles of 1) motivational interview, will be based on 2) Theory of self-determination, taking into account 3) components of the Transtheoretical Model of Change and the Theory of Planned Behavior.
Other Name: Behavioral Change

Experimental: WalkingPad plus Virtual Assistant - CyberWPad Group
The participants in Experimental Group 2 will receive a prescription of an HbET consisting of a walking plan with a duration greater than 30 min per session, frequency of at least three sessions per week, use of near-maximal pain during training as claudication pain endpoint, with the support of a virtual assistant that will give motivational support.
Behavioral: WalkingPad plus Virtual Assistant - CyberWPad Group
The 24-week walking program will be monitored by the WalkingPAD application, which will accompany the patient on their walks and record their adherence to the previously defined individual program. Motivational support will be provided by a virtual assistant through daily and on-the-spot interactions and through support and motivational messages.
Other Name: Behavioral Change

Active Comparator: Paper WalkingPad group - PaperWPad Group
The participants in the Active Control Group will receive a prescription of an HbET consisting of a walking plan with a duration greater than 30 min per session, frequency of at least three sessions per week, use of near-maximal pain during training as claudication pain endpoint, with the support of a behavioral motivational intervention delivered by a health psychologist.
Behavioral: WalkingPad group - Paper WPad Group
The 24-week walking program will be supported by a printed prescription of an individualized HbET previously defined on the WalkingPAD platform. However, this group of patients will not have the support of an application to monitor and record adherence to the program. Motivational support for a behavioral intervention will include two face-to-face sessions and the following contacts will be made over the phone. The behavioral motivational intervention will follow the principles of 1) motivational interview, will be based on 2) Theory of self-determination, taking into account 3) components of the Trans-Theoretical Model of Change and the Theory of Planned Behavior.
Other Name: Behavioral Change




Primary Outcome Measures :
  1. Maximum Walking Distance (MWD) [ Time Frame: Changes from before-assignment (T0 - treadmill and T1 - 6min walk test) to T2 (3 months), and to T3 (six-months) ]
    Maximum Walking Distance will be measured through the Treadmill Test and the 6 Minute Walk Test (6 MWT), in meters. The 6 MWT is a performance-based measure that evaluates the functional capacity of the individual to walk over a total of 6 min on a 100ft (≈30m) hallway, providing information regarding all the systems during physical activity.

  2. Pain-free Walking Distance (PFWD) [ Time Frame: Changes from before-assignment (T0 - treadmill and T1 - 6min walk test) to T2 (3 months), and to T3 (six-months) ]
    Pain-free Walking Distance (PFWD) will be measured through the Treadmill Test and the 6 Minute Walk Test (6 MWT), in meters. The 6 MWT is a performance-based measure that evaluates the functional capacity of the individual to walk over a total of 6 min on a 100ft (≈30m) hallway, providing information regarding all the systems during physical activity.

  3. Functional Walking Distance (FWD) [ Time Frame: Changes from before-assignment (T0 - treadmill and T1 - 6min walk test) to T2 (3 months), and to T3 (six-months) ]
    Functional Walking Distance (FWD) will be measured through the Treadmill Test and the 6 Minute Walk Test (6 MWT), in meters. The 6 MWT is a performance-based measure that evaluates the functional capacity of the individual to walk over a total of 6 min on a 100ft (≈30m) hallway, providing information regarding all the systems during physical activity.


Secondary Outcome Measures :
  1. Physical Quality of Life [ Time Frame: Changes from T0 (before-assignment) to T2 (3 months), and to T3 (six-months) ]
    Physical Quality of Life will be assessed through the Short-Form Health Survey (SF-36). Raw scores are transformed into a scale from 0 to 100. Higher results correspond to better physical quality of life. Higher results correspond to a better physical quality of life.

  2. Mental Quality of Life [ Time Frame: Changes from T0 (before-assignment) to T2 (3 months), and to T3 (six-months) ]
    Mental Quality of Life will be assessed through the Short-Form Health Survey (SF-36). Raw scores are transformed into a scale from 0 to 100. Higher results correspond to better mental quality of life. Higher results correspond to a better mental quality of life.

  3. Vascular Disease specific Quality of Life [ Time Frame: Changes from T0 (before-assignment) to T2 (3 months), and to T3 (six-months) ]
    Vascular disease-specific quality of Life will be assessed through the Vascular Disease-specific Quality of Life (VAsQoL-6). This is a specific measure for patients with PAD, assessing health-related quality of life in PAD. Scores range between 6 and 24, with higher results corresponding to a better quality of life associated with vascular disease.

  4. Walking Impairment [ Time Frame: Changes from T0 (before-assignment) to T2 (3 months), and to T3 (six-months) ]

    Walking impairment will be assessed through the Walking Impairment Questionnaire (WIQ) that assesses walking abilities in three domains:

    • distance (distances that the individual can walk) with scores ranging between 0 and 28, with higher results corresponding to greater distance;
    • speed (the speed that the individual can walk) with scores ranging between 0 and 16, with higher results corresponding to greater speed;
    • stairs (number of stairs that the individual can climb) with scores ranging between 0 and 12, with higher results corresponding to greater ability to climb stairs;


Other Outcome Measures:
  1. Sociodemographic Data [ Time Frame: T0 (before-assignment) ]
    The following socio-demographic data will be collected: gender; age; living environment; marital status; professional status; rural or urban areas of residence.

  2. Clinical Data [ Time Frame: T1 (before intervention) to T2 (3 months), and to T3 (six-months) ]
    The clinical data to collect will be: medical history, surgical history, chronic medication, lifestyle habits (alcohol and tobacco consumption, hours of sleep, and the number of meals per day).

  3. Ankle-brachial-index (ABI) [ Time Frame: T1 (before intervention) to T2 (3 months), and to T3 (six-months) ]
    The ABI measures the systolic pressures at the brachial artery, anterior tibial artery, and posterior tibial artery in the supine position in millimeters of mercury (mmHg), and will be assessed through a validated and certified Doppler device.

  4. Transcutaneous Oxygen Pressure (TcPO2) [ Time Frame: T1 (before intervention) to T2 (3 months), and to T3 (six-months) ]
    TcPO2 measures limb ischemia in millimeters of mercury (mmHg), and will be assessed through a validated and certified TcPO2 patient monitor.

  5. Hand Strength [ Time Frame: T1 (before intervention) to T2 (3 months), and to T3 (six-months) ]
    HGS measures and determines musculoskeletal function, weakness and disability in kilograms (kg), through a hand-held dynamometer.

  6. Weight [ Time Frame: T1 (before intervention) to T2 (3 months), and to T3 (six-months) ]
    Weight will be mesured in kilograms (kg), through a bioimpedance scale.

  7. Height [ Time Frame: [Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)] ]
    Height will be measured in Meters (mts), using a tape measure.

  8. Body Mass Index [ Time Frame: [Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)] ]
    Body mass index (kg/m2) will be measured through a bioimpedance scale.

  9. Resting metabolism [ Time Frame: [Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)] ]
    Resting metabolism of the patient will be measured in kilocalories (kcal) through a bioimpedance scale.

  10. Body fat percentage [ Time Frame: [Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)] ]
    Body fat percentage (%) will be measured through a bioimpedance scale.

  11. Visceral fat level [ Time Frame: [Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)] ]
    Visceral fat level (%) will be measured through a bioimpedance scale.

  12. Skeletal muscle percentage [ Time Frame: [Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)] ]
    Skeletal muscle percentage (%) will be measured through a bioimpedance scale.

  13. Mental State [ Time Frame: T0 (before-assignment) ]
    Mental state will be measured through the Mini-Mental State Examination (MMSE). This is a widely used test of cognitive function among the elderly, including tests of orientation, attention, memory, language, and visual-spatial skills. Higher results correspond to a better mental state.

  14. Physical Performance [ Time Frame: Changes from T0 (before-assignment) to T2 (3 months), and to T3 (six-months) ]
    Change in Physical performance will be measured through the International Physical Activity Questionnaire for the elderly (IPAQ_E) assesses self-reported moderate-to-vigorous physical activity (MVPA) and sedentary behavior (SB) in older adults, with scores ranging from 0 to indefinite minutes of physical activity per week and higher results correspond to a greater amount of physical activity performed. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.

  15. Anxiety Symptoms [ Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months) ]
    Anxiety symptoms will be measured through the Geriatric Anxiety Scale (GAS) assesses anxiety symptoms in older adults, with scores ranging from 0 to 5 and higher results correspond to more anxiety symptoms.

  16. Depression Symptoms [ Time Frame: [Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)] ]
    Depression symptoms will be measured through the Geriatric Depression Scale-5 (GDS) assesses depressive symptoms in older adults, with scores ranging from 0 to 5 and higher results correspond to more depression symptoms.

  17. Stage of Change [ Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months) ]
    The Stage of Change will be measured through the Walking Motivation/Readiness for Change Questionnaire (WM/RCQ) which identifies the Stage of Change (SOC) in which participants are at the moment regarding walking training (Pre-contemplation, Contemplation, Preparation, Action, and Maintenance). Participants can only be in one stadium so the answer is exclusive to a single stadium (yes = 1; no = 0).

  18. Locus of Causality [ Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months) ]
    Locus of causality will be measured through the Locus of Causality for Exercise Scale (LCES). This scale assesses the extent to which individuals feel that they freely choose to exercise rather than feeling that they have to for some reason. The response scale ranges from 3 to 18. Higher results indicate higher levels of autonomy (locus of causality internal).

  19. Walking Planned Behavior [ Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months) ]
    Planned behavior will be assessed through the Walking Planned Behavior Questionnaire (WPBQ), which assesses intentions, attitudes, subjective norms, action and coping plans regarding walking. The response scale of ranges from 3 to 18. On the intentions scale, the score ranges between 2 and 10 points and higher scores indicate higher intention in do physical activity (walking); On the attitudes scale, the score ranges between 5 and 25 points and higher scores indicate a more positive the attitudes towards physical activity; On the subjective norms scale, the score ranges between 3 and 15 points, in which the higher the score, the higher is the perception of the importance attributed by other people to physical activity.

  20. Illness representations [ Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months) ]
    Representations regarding PAD will be measured through the Illness Perception Questionnaire - Brief (IPQ-B). This assesses illness perceptions, with a response scale ranging from 0 to 10. Higher scores indicate more threatening perceptions regarding PAD.

  21. Basic Psychological Need Satisfaction [ Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months) ]
    Basic Psychological Need Satisfaction will be assessed through the Psychological Need Satisfaction in Exercise Scale (PNSES). This scale assesses perceived psychological need satisfaction of the three basic psychological needs in the context of exercise (walking training): autonomy, competence, and positive relationship (relatedness). The response scale ranges from 12 to 60. Higher scores indicate more perceptions of psychological need fulfilment in exercise (walking).

  22. Behavioral Regulation [ Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months) ]
    Regulation in Exercise will be measured through the Behavioral Regulation in Exercise Questionnaire (BREQ-3). This scale assesses the motivational regulations for walking training and the response scale ranges from 0 to 12 for each type of regulation. Higher results indicate higher levels of one of the following types of behavioral regulation: amotivation, external, introjected, identified, integrated, and intrinsic.

  23. Cost-effectiveness of home-based exercise Vs. clinical-base exercise [ Time Frame: At 6 months ]
    Compare cost-effectiveness analysis of HBET Control Vs. HBET with motivational support Vs. HBET with a virtual assistant. The outcome measure will be cost per quality adjusted life year (QALY)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. PAD with IC (Fontaine II ou Rutherford 1-3) due to atherosclerotic disease;
  2. ABI below 0.9 at rest or below 0.73 after exercise (20% decrease);
  3. Age range between 50 and 80;
  4. MWD in treadmill test between 50 and 500 meters;

Exclusion Criteria:

  1. Asymptomatic PAD;
  2. Critical Ischemia (Fontaine III/IV or Rutherford 4-6);
  3. Previous lower extremity vascular surgery, angioplasty, or lumbar sympathectomy;
  4. Any condition other than PAD that limits walking;
  5. Miocardial Infarction or Unstable Angina in the last 6 months;
  6. Inability to obtain ABI measure because of non-compressible vessels;
  7. Use of cilostazol and pentoxifylline initiated within 3 months before the investigation;
  8. Active cancer, renal disease, or liver disease;
  9. Severe chronic obstructive pulmonary disease (GOLD stage III/IV);
  10. Severe congestive heart failure (NYHA class III/IV);

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): NCT04749732


Contacts
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Contact: Ivone Silva, PhD 919317751 heitor.ivone@gmail.com
Contact: Hugo Paredes, PhD (+351) 259 350 000 ext 4786 hparedes@utad.pt

Locations
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Portugal
Centro Hospitalar do Porto Recruiting
Porto, Portugal, 4099-001
Contact: Ivone Silva, PhD    (+351) 22 207 7500    heitor.ivone@gmail.com   
Contact: Hugo Paredes, PhD    (+351) 259 350 000 ext 4786    hparedes@utad.pt   
Sponsors and Collaborators
Centro Hospitalar do Porto
Foundation for Science and Technology, Portugal
University of Trás-os-Montes and Alto Douro
Institute for Systems and Computer Engineering, Technology and Science-INESC TEC
Investigators
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Principal Investigator: Ivone Heitor, PhD Centro Hospitalar do Porto
Publications:
Aboyans V, Ricco JB, Bartelink MEL, Björck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Röther J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I, Document Reviewers, Widimsky P, Kolh P, Agewall S, Bueno H, Coca A, De Borst GJ, Delgado V, Dick F, Erol C, Ferrini M, Kakkos S, Katus HA, Knuuti J, Lindholt J, Mattle H, Pieniazek P, Piepoli MF, Scheinert D, Sievert H, Simpson I, Sulzenko J, Tamargo J, Tokgozoglu L, Torbicki A, Tsakountakis N, Tuñón J, Vega de Ceniga M, Windecker S, Zamorano JL. Editor's Choice - 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018 Mar;55(3):305-368. doi: 10.1016/j.ejvs.2017.07.018. Epub 2017 Aug 26. Review.
Writing Group Members, Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jiménez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. Erratum in: Circulation. 2016 Apr 12;133(15):e599.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ivone Silva, Principal Investigator, Centro Hospitalar do Porto
ClinicalTrials.gov Identifier: NCT04749732    
Other Study ID Numbers: 069-DEFI/068-CES
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ivone Silva, Centro Hospitalar do Porto:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Intermittent Claudication
Walking ability
Health-related Quality of Life
Home-based Exercise Therapy
Pervasive virtual assistant
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases