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Home-based Exercise for Management of HIV-associated Cardiovascular Disease Risk

Primary Purpose

Cardiovascular Diseases, Hyperlipidemia, Obesity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Physical Activity Group
Standard Care Group
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring HIV, physical activity, cardiovascular disease risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 18.5 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • The Citadel
  • University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physical activity group

Standard care group

Arm Description

Subjects will participant in physical activity program

This group will not receive a physical activity intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cardiorespiratory Fitness
Each participant will complete a graded exercise stress test (GXT) with indirect calorimetry. This test will be used to screen for abnormal physiological responses to exercise and for determining the participant's maximal ability to utilize oxygen (an index of cardiorespiratory fitness).

Full Information

First Posted
June 8, 2011
Last Updated
April 27, 2021
Sponsor
University of South Carolina
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT01377064
Brief Title
Home-based Exercise for Management of HIV-associated Cardiovascular Disease Risk
Official Title
Home-based Exercise for Management of HIV-associated Cardiovascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Carolina
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Hyperlipidemia, Obesity
Keywords
HIV, physical activity, cardiovascular disease risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical activity group
Arm Type
Experimental
Arm Description
Subjects will participant in physical activity program
Arm Title
Standard care group
Arm Type
Active Comparator
Arm Description
This group will not receive a physical activity intervention
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Group
Intervention Description
9 months of home based physical activity meeting HHS recommendations for physical activity for all americans
Intervention Type
Other
Intervention Name(s)
Standard Care Group
Intervention Description
No intervention, the group will be followed under their standard medical care.
Primary Outcome Measure Information:
Title
Amount of Physical Activity
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Cardiorespiratory Fitness
Description
Each participant will complete a graded exercise stress test (GXT) with indirect calorimetry. This test will be used to screen for abnormal physiological responses to exercise and for determining the participant's maximal ability to utilize oxygen (an index of cardiorespiratory fitness).
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 18.5 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
The Citadel
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23706094
Citation
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.
Results Reference
derived

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Home-based Exercise for Management of HIV-associated Cardiovascular Disease Risk

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