Strength Training and Endurance Exercise for LIFE

NCT ID: NCT02101060

Last Updated: 2021-05-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-15

Study Completion Date

2019-10-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Research is needed to determine safe and effective exercise rehabilitation programs to prevent and improve physical disability in older adults living with HIV. This problem is of great importance to the VA. The majority of the 25 thousand HIV-infected veterans are over 50 years of age (64%). The combined effect of aging and inflammation increase the risk for physical disability in older HIV-infected veterans. This translational exercise training trial will examine the cardiac and skeletal muscle effects of combined aerobic exercise and resistance training to attenuate the functional declines of aging with HIV by reducing the deleterious consequences of chronic inflammation. Findings will guide future rehabilitation research on cardiac remodeling and inflammation of skeletal muscle. The proposed research will advance the goal to develop effective rehabilitation strategies that improve the health of older HIV-infected veterans.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The objective of this study is to determine the effect of exercise training on the central (cardiovascular) and peripheral (muscular) impairments underlying poor physical function by comparing older HIV-infected veterans randomized to combine aerobic and resistance exercise training versus usual care. The study hypothesis is that a progressive aerobic and resistance rehabilitation program will increase aerobic capacity and muscle strength, which will be mediated by improved diastolic function, increased muscle mass, and decreased systemic inflammation. To test this hypothesis, investigators will conduct a randomized 16-week trial of progressive aerobic and resistance training versus usual care control in 40 sedentary older (50+ years) HIV-infected veterans. The study will determine the effects of exercise training on aerobic capacity and diastolic function, and their relationship to changes in biomarkers of systemic inflammation and cardiac fibrosis (AIM 1). The study will also determine the effect of exercise training on strength and muscle mass, and their relationship to changes in biomarkers of systemic inflammation (AIM 2).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

exercise

16-week progressive aerobic and resistance exercise training

Group Type EXPERIMENTAL

exercise

Intervention Type OTHER

16-week progressive aerobic and resistance exercise training

control

usual care controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

exercise

16-week progressive aerobic and resistance exercise training

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* HIV-infected veterans adult 50 years of age and older under medical care for HIV
* Antiretroviral Therapy

Exclusion Criteria

* Patients with comorbid conditions that could have a potential impact on their ability to perform exercise testing and training will be excluded according to the American College of Sports Medicine
* Only sedentary adults will be eligible. Individuals that participate in regular structured aerobic exercise or resistance training in the prior 6-months will be excluded
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kris Ann K Oursler, MD

Role: PRINCIPAL_INVESTIGATOR

Salem VA Medical Center, Salem, VA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, United States

Site Status

Salem VA Medical Center, Salem, VA

Salem, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Briggs BC, Ryan AS, Sorkin JD, Oursler KK. Feasibility and effects of high-intensity interval training in older adults living with HIV. J Sports Sci. 2021 Feb;39(3):304-311. doi: 10.1080/02640414.2020.1818949. Epub 2020 Sep 23.

Reference Type RESULT
PMID: 32962523 (View on PubMed)

Oursler KK, O'Boyle HM, Briggs BC, Sorkin JD, Jarmukli N, Katzel LI, Freiberg MS, Ryan AS. Association of Diastolic Dysfunction with Reduced Cardiorespiratory Fitness in Adults Living with HIV. AIDS Patient Care STDS. 2019 Dec;33(12):493-499. doi: 10.1089/apc.2019.0149.

Reference Type RESULT
PMID: 31821043 (View on PubMed)

Oursler KK, Iranmanesh A, Jain C, Birkett KL, Briggs BC, Garner DC, Sorkin JD, Ryan AS. Short Communication: Low Muscle Mass Is Associated with Osteoporosis in Older Adults Living with HIV. AIDS Res Hum Retroviruses. 2020 Apr;36(4):300-302. doi: 10.1089/AID.2019.0207. Epub 2019 Dec 23.

Reference Type RESULT
PMID: 31762303 (View on PubMed)

Ryan AS, Roy A, Oursler KK. Gait and Balance Biomechanics in Older Adults With and Without Human Immunodeficiency Virus. AIDS Res Hum Retroviruses. 2019 Nov/Dec;35(11-12):1089-1094. doi: 10.1089/AID.2019.0102.

Reference Type RESULT
PMID: 31547668 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

O0667-R

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Exercise for Patients With HIV Infections
NCT00910936 UNKNOWN PHASE2/PHASE3