Cardiovascular DiseasesPhase 1NCT01377064
Home-based Exercise for Management of HIV-associated Cardiovascular Disease Risk
A Phase 1 study testing Physical Activity Group in people with Cardiovascular Diseases and Hyperlipidemia, run by University of South Carolina at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Hyperlipidemia, Obesity
- What is being tested?
- Physical Activity Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Jul 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Citadel
Charleston, South Carolina, 29425
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: Home-based Exercise for Management of HIV-associated Cardiovascular Disease
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.
- Conditions
- Cardiovascular Diseases, Hyperlipidemia, Obesity
- Being tested
- Physical Activity Group, Standard Care Group
- Keywords
- HIV, physical activity, cardiovascular disease risk
- Medical subject headings
- Cardiovascular Diseases, Hyperlipidemias, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity GroupBehavioural
9 months of home based physical activity meeting HHS recommendations for physical activity for all americans
Standard Care GroupOther
No intervention, the group will be followed under their standard medical care.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity group | Experimental | Subjects will participant in physical activity program Receives: Behavioral: Physical Activity Group |
| Standard care group | Active comparator | This group will not receive a physical activity intervention Receives: Other: Standard Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (1)
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).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377064
- Sponsor's protocol ID
- Pro00007339
- Other IDs
- 1R21NR011281
- Status last verified
- Apr 2021
- First submitted
- 8 Jun 2011
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23706094
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Exercise for Management of HIV-associated Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT01377064
- Acronym / sponsor ID
- Pro00007339
- Conditions
- Cardiovascular Diseases, Hyperlipidemia, Obesity
- Keywords
- HIV, physical activity, cardiovascular disease risk
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Mar 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity group | Experimental | Behavioral: Physical Activity GroupSubjects will participant in physical activity program |
| Standard care group | Active comparator | Other: Standard Care GroupThis group will not receive a physical activity intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity Group9 months of home based physical activity meeting HHS recommendations for physical activity for all americans | Behavioural | Physical activity group |
| Standard Care GroupNo intervention, the group will be followed under their standard medical care. | Other | Standard care group |
Primary outcome
Amount of Physical Activity
Time frame: 9 months
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.
1 secondary outcome
Cardiorespiratory Fitness
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 23706094Jaggers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Physical Activity Group in people with Cardiovascular Diseases and Hyperlipidemia, run by University of South Carolina at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Physical Activity (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01377064, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.