NCT01377064

Brief Summary

Because of advances in drug treatment, people living with HIV/AIDS (PLWHA) are living longer, but are also at greater risk for cardiovascular disease (CVD) and diabetes. Exercise and increased physical activity can reduce the risk factors for these diseases in PLWHA, but no studies have tested an at-home exercise program that would benefit low income people and others who do not have access to exercise facilities. This study will test the feasibility of an at-home exercise program for PLWHA and prepare for a full-scale intervention study, which may lead to a reduction in CVD risk among PLWHA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 cardiovascular-diseases

Timeline
Completed

Started Mar 2011

Typical duration for phase_1 cardiovascular-diseases

Geographic Reach
1 country

2 active sites

Status
completed

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

March 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

2.3 years

First QC Date

June 8, 2011

Last Update Submit

April 27, 2021

Conditions

Cardiovascular DiseasesHyperlipidemiaObesity

Keywords

HIVphysical activitycardiovascular disease risk

Outcome Measures

Primary Outcomes (1)

  • Amount of Physical Activity

    Accelerometer data will be the primary means of determining the participants' physical activity levels. Participants will be instructed to wear the accelerometer at baseline, 4 months, and 9 months. The participants will be required to wear the accelerometer during the waking hours for seven consecutive days. Data from participants with at least four days and at least 10 hours per day will be included.

    9 months

Secondary Outcomes (1)

  • Cardiorespiratory Fitness

    9 months

Study Arms (2)

Physical activity group

EXPERIMENTAL

Subjects will participant in physical activity program

Behavioral: Physical Activity Group

Standard care group

ACTIVE COMPARATOR

This group will not receive a physical activity intervention

Other: Standard Care Group

Interventions

Physical Activity GroupBEHAVIORAL

9 months of home based physical activity meeting HHS recommendations for physical activity for all americans

Physical activity group
Standard Care GroupOTHER

No intervention, the group will be followed under their standard medical care.

Standard care group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years and older
  • Medical diagnosis of HIV-1 positive serostatus
  • Sedentary lifestyle: not actively exercising ≥ 3 d•wk-1 for 20 min per session
  • kg/m2 \< BMI \< 40.0 kg/m2
  • Stable, DHHS-approved ART regimen for previous 3 months, with HIV viral load below 75 copies/mL
  • Capable of performing the required exercise regimen
  • Have daily access to a telephone for approximately 10 months
  • Capacity and willingness to provide informed consent and accept randomized group assignment

You may not qualify if:

  • Individuals who have a clinical history strongly suggestive of Type 1 diabetes.
  • History of serious arrythmias, cardiomyopathy, congestive heart failure, stroke or transient ischemic cerebral attacks, peripheral vascular disease with intermittent claudication, myocardial infarction, or CABG.
  • Malignancies in the past 5 years, except therapeutically controlled skin cancer.
  • Plans to be away \> 4 weeks in the next 9 months
  • Score of 5 or greater on the DAST or MAST (signifying excessive use of drugs or alcohol).
  • Weight loss in excess of 10% body weight in previous 12 weeks.
  • Chronic or recurrent respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric conditions.
  • Inflammatory-related conditions such as collagen disorders.
  • Any other medical condition or disease that is life-threatening or that can interfere with or be aggravated by exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Citadel

Charleston, South Carolina, 29425, United States

Location

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (1)

  • Jaggers JR, Dudgeon W, Blair SN, Sui X, Burgess S, Wilcox S, Hand GA. A home-based exercise intervention to increase physical activity among people living with HIV: study design of a randomized clinical trial. BMC Public Health. 2013 May 24;13:502. doi: 10.1186/1471-2458-13-502.

    PMID: 23706094DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHyperlipidemiasObesityMotor Activity

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2011

First Posted

June 20, 2011

Study Start

March 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

US(2)