NCT03392805

Brief Summary

exercise and physical activity can have an anti-inflammatory effect, while there is evidence that a sedentary lifestyle could be the basis for the development of systemic inflammation and increased cardiovascular risk. The primary objective is to assess whether regular physical activity is able to induce a decrease in systemic immune-activation in HIV positive patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

3 years

First QC Date

January 2, 2018

Last Update Submit

January 2, 2018

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

  • Delta between Rockport Walking Test value at T0 and T6

    6 months

Secondary Outcomes (10)

  • Delta between CD4+CD38+ value at T0 and T6

    6 months

  • Delta between CD8+CD38+ value at T0 and T6

    6 months

  • Delta between CD4+HLADR+ value at T0 and T6

    6 months

  • Delta between CD8+HLADR+ value at T0 and T6

    6 months

  • Delta between TNF-α value at T0 and T6

    6 months

  • +5 more secondary outcomes

Study Arms (2)

sedentary life style

EXPERIMENTAL
Behavioral: physical activity

physically active life style

NO INTERVENTION

Interventions

physical activityBEHAVIORAL

beginning of regular physical activity under the supervision of a coach

sedentary life style

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18-60 years
  • Patients who have signed informed consent
  • HIV positive patients
  • Patients who have performed a sports medical examination with ECG and are suitable for non-competitive physical activity.

You may not qualify if:

  • Anemia, pregnancy or any other contraindication to blood sampling and sports activity
  • Patients suffering from cardiomyopathies and ischemic heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Public Health and Infectious Diseases, University of Rome "La Sapienza"

Rome, 00161, Italy

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Gabriella d'Ettorre, MD PhD

CONTACT

+39-06-49970324gabriella.dettorre@uniroma1.it

Giancarlo Ceccarelli, MD PhD MSc

CONTACT

+39-06-49970900giancarlo.ceccarelli@uniroma1.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reasercher co-PI

Study Record Dates

First Submitted

January 2, 2018

First Posted

January 8, 2018

Study Start

January 1, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

January 8, 2018

Record last verified: 2018-01

Locations

IT(1)