The Effects of Exercise Training in Vascular Function of... | NCT03343522

Studies
The Effects of Exercise Training in Vascular Function of Patients Living With HIV

NCT03343522

Sponsor

Instituto Nacional de Cardiologia de Laranjeiras

Status

Completed

Last Update Posted

Mar 7, 2023Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

HIV/AIDS

Interventions

Exercise

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2017Actual

Primary Completion Date

Dec 20, 2022Actual

Completion Date

Mar 3, 2023Actual

First Submitted Date

Nov 10, 2017

First Submission Date that Met QC Criteria

Nov 10, 2017

First Posted Date

Nov 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2023

Last Update Posted Date

Mar 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Juliana Pereira Borges, Principal Investigator, Instituto Nacional de Cardiologia de LaranjeirasPrincipal Investigator

Lead Sponsor

Instituto Nacional de Cardiologia de LaranjeirasOTHER

Collaborators

Name	Class
Rio de Janeiro State University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Introduction: It is well known that the infection caused by the Human Immunodeficiency Virus (HIV) is associated to a higher cardiovascular event risk. On the other hand, it is clear that the aerobic exercise training induces improvements in autonomic control and vascular function, through increases in vasodilator agents and blood vessels number. However, the investigators could not find previous works that studied the microvascular function in response to exercise training in HIV patients.

Objectives: To study the impact of aerobic exercise training in endothelial function of HIV patients. In addition, the investigators will verify the association of the physical fitness to the nitric oxide bioavailability, angiogenesis and lipid profile in HIV patients.

Methods: The study subjects will be composed by HIV patients, that will be randomly divided in two different groups: exercised and sedentary. The subjects will be tested before and after training in regards to endothelial function, nitric oxide bioavailability, physical fitness and lipid profile, through flowmetry, colorimetric essays, maximal cardiopulmonary exercise test, and biochemical tests; respectively. The exercise training will be performed in a treadmill for 12 weeks, 3 times a week, 40 minutes each section.

Expected Results: The investigators expect to achieve markers that will help in understanding the interaction of HIV with several factors that contribute to an increased endothelial function after exercise training.

Detailed Description

HIV-infection triggers a massive oxygen reactive species production, increasing oxidative stress and vascular complications. Despite the importance of therapeutic strategies in reducing the cardiovascular risk among HIV-infected patients (HIVP), exercise-related effects upon macro-and-microvascular endothelial function and oxidative stress in HIVP have not been previously reported.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sedentarism	No Intervention	Patients assigned to this arm shall not perform regular exercise training.
Exercise Training	Experimental	Patients assigned to this arm will be enrolled in exercise training program.	Behavioral: Exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise	Behavioral	A multimodal exercise training program (aerobic, strength and flexibility exercises) for 6 months (60-min sessions performed 3 times/week with moderate intensity).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skin microvascular blood flow	Microvascular reactivity will be evaluated by laser speckle contrast imaging with laser wavelength of 785 nm in combination with iontophoresis of acetylcholine (ACh) and sodium nitroprusside (SNP) for noninvasive and continuous measurements of cutaneous microvascular flow changes in the forearm.	Baseline and 3 months

Secondary Outcomes

Measure	Description	Time Frame
Peak Oxygen consumption	Measured at a maximal graded exercise test.	Baseline and 3 months
Nitrite/nitrate	Colorimetric assay kit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

sedentarism for at least 6 months;
diagnosis of HIV infection.

Exclusion Criteria:

opportunistic diseases;
nephropathies;
cardiovascular diseases;
locomotor limitations;
liver diseases.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Juliana P Borges, PhD	Insituto Nacional de Cardiologia and Rio de Janeiro State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rio de Janeiro State University		Rio de Janeiro	Rio de Janeiro	20550-900	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided