Exercise for Healthy Aging: The Impact of HIV and Aging o... | NCT02404792

ID	Type	Description	Link
K23AG050260	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Institute on Aging (NIA)	NIH
Gilead Sciences	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HIV-uninfected	Active Comparator	HIV-uninfected men and women, age 50-70 years. All participants will exercise at a moderate intensity (cardiovascular + resistance training) for 12 weeks, then will be randomized to continue moderate intensity or advance to high intensity exercise for an additional 12 weeks.	Other: High-intensity cardiovascular and resistance exercise Other: Moderate-intensity cardiovascular and resistance exercise
HIV-infected	Experimental	HIV-infected men and women, age 50-70 years. All participants will exercise at a moderate intensity (cardiovascular + resistance training) for 12 weeks, then will be randomized to continue moderate intensity or advance to high intensity exercise for an additional 12 weeks.	Other: High-intensity cardiovascular and resistance exercise Other: Moderate-intensity cardiovascular and resistance exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High-intensity cardiovascular and resistance exercise	Other		HIV-infected HIV-uninfected
Moderate-intensity cardiovascular and resistance exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Rise From a Chair 10 Times (Modified From the Original Short Physical Performance Battery)	Chair rise time is measured as a continuous variable of time to stand up from a sitting position 10 times. Lower number = faster; larger number = slower	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes in Insulin-like Growth Factor (IGF)-1	Measures at baseline and following 24 weeks of exercise	24 weeks
Changes in Inflammation (Interleukin-6 [IL-6], Soluble Tumor Necrosis Factor Receptors 1 and TNF-alpha.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 50-75
HIV+ must be on ART for a minimum of 2 years with viral load <200 copies/mL
Sedentary
cluster of differentiation 4 (CD4) T-cell count >200 cells/microliter
BMI >19 and <41
Among females, must be post-menopausal
Able to perform activities of daily living with out assistance

Exclusion Criteria:

Diabetes, poorly controlled with HgbA1c >7.5; on insulin
On growth hormone (or growth hormone axis) therapy, intramuscular testosterone, corticosteroids.
Known active hepatitis B or C (viremia).
Severe liver disease
Uncontrolled hypertension (SPB >180 or diastolic >100).
Underlying cardiac conditions that would make exercise or exercise testing potentially unsafe (unstable ischemic heart disease, Class III or IV heart failure clinically significant aortic stenosis, uncontrolled angina, or uncontrolled arrhythmia)
pulmonary disease requiring the use of supplemental oxygen ≥ 4 liters with physical exertion
current diagnosis of malignancy (excluding non-melanoma skin cancers) within 48 weeks prior to enrollment
surgery/trauma/injury/fracture within 24 weeks prior to enrollment that may impact a subject's ability to exercise
history of stroke with residual deficits that may impact ability to exercise; orthopedic problems (e.g., severe osteoarthritis, rheumatoid arthritis) that greatly limit the ability to perform moderate-intensity resistance exercise (e.g., unable to be properly positioned in exercise equipment or to have severely restricted range of motion even after modifications have been made)
weight over 300 pounds
Montreal Cognitive Assessment (MOCA) score < 18 (will be evaluated at screening visit after consent obtained)
AIDS-defining opportunistic infection within the 24 weeks prior to enrollment
Person who appear to have unstable health, are incapable of safely participating in the exercise intervention, or are felt to have a life expectancy of < 1 year.
Participants on anticoagulants (clopidogrel, Coumadin, etc) will be excluded from the muscle biopsy.
Aspirin and Non-steroidal anti-inflammatory agents are not exclusions but should be stopped 1 week prior to muscle biopsy (subset of subjects).

Name	Affiliation	Role
Kristine Erlandson, MD, MSc	University of Colorado, Denver	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado- Anschutz Medical Campus		Aurora	Colorado	80045	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40134456	Derived	Kulik GL, Wilson MP, Jankowski CM, Fourman LT, Erlandson KM. Examining the Heterogeneity of Exercise Response Among Sedentary Older Adults: A Descriptive Analysis. J Aging Res. 2025 Mar 18;2025:6952002. doi: 10.1155/jare/6952002. eCollection 2025.
35302400	Derived	Bowman ER, Wilson M, Riedl KM, MaWhinney S, Jankowski CM, Funderburg NT, Erlandson KM. Lipidome Alterations with Exercise Among People With and Without HIV: An Exploratory Study. AIDS Res Hum Retroviruses. 2022 Jul;38(7):544-551. doi: 10.1089/AID.2021.0154. Epub 2022 Apr 21.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Participants With HIV	All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for >2 years and a CD4 T-cell count >200 cells/µL. At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise or advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 15, 2016

Arm/Group Information

ID	Title	Description
BG000	HIV-Uninfected Controls	All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for >2 years and a CD4 T-cell count >200 cells/µL. At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) or advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks.
BG001	Participants With HIV	All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for >2 years and a CD4 T-cell count >200 cells/µL. At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00037 BG00132 BG00269

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Geometric Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00058.7± 6.9 BG00156.8± 5.7 BG00257.8± 6.4

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002 BG0014 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0004 BG0014 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to Rise From a Chair 10 Times (Modified From the Original Short Physical Performance Battery)

Chair rise time is measured as a continuous variable of time to stand up from a sitting position 10 times. Lower number = faster; larger number = slower

37 and 32 had baseline values; 29 and 27 (uninfected and with HIV, respectively) completed 24 weeks.

Posted

Mean

95% Confidence Interval

percentage change

24 weeks

ID	Title	Description
OG000	HIV-uninfected Controls	All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for >2 years and a CD4 T-cell count >200 cells/µL. At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) or advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks.
OG001	Participants With HIV	All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for >2 years and a CD4 T-cell count >200 cells/µL. At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks.

Units	Counts
Participants	OG00037 OG00132

Title

Denominators

Categories

Change 0-12 weeks

- ParticipantsOG00031
- ParticipantsOG00128

Title	Measurements
	OG000-20(-24 to -16)

Secondary

Changes in Insulin-like Growth Factor (IGF)-1

Measures at baseline and following 24 weeks of exercise

Missing data on one participant with HIV that completed the study. Data listed below ONLY includes data on persons with measurements at both baseline and week 24.

Posted

Geometric Mean

95% Confidence Interval

IGF-1 (ng/mL)

24 weeks

ID	Title	Description
OG000	Participants With HIV	All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for >2 years and a CD4 T-cell count >200 cells/µL. At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise or advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks.
OG001	HIV-Uninfected Controls	All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded.At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise or advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks.

Secondary

Changes in Inflammation (Interleukin-6 [IL-6], Soluble Tumor Necrosis Factor Receptors 1 and TNF-alpha.

The primary outcome is change from 0 to 24 weeks. These changes in inflammation are measured at baseline (pre-exercise) and at 24 weeks (post exercise).

Posted

Mean

95% Confidence Interval

percentage of change

Baseline and 24 weeks

ID	Title	Description
OG000	HIV-uninfected Controls	All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for >2 years and a CD4 T-cell count >200 cells/µL. At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) or advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks.
OG001	Participants With HIV	All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for >2 years and a CD4 T-cell count >200 cells/µL. At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	HIV-uninfected Controls	All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for >2 years and a CD4 T-cell count >200 cells/µL. At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) or advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks.	0	37	0	37	9	37
EG001	Participants With HIV	All participants were aged 50 to 75 years, sedentary (<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for >2 years and a CD4 T-cell count >200 cells/µL. At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) advance to high-intensity (60-70% of week 13 VO2 max and >80% 1-RM) for the remaining 12 weeks.	0	32	0	32	17	32

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Musculoskeletal injury/pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	Included aches, pains, strains, etc.	EG0009 events6 affected37 at risk EG00120 events13 affected32 at risk
Hernia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment		EG0001 events1 affected37 at risk EG0010 events0 affected32 at risk
Dizzyness or lightheadedness	Cardiac disorders	Non-systematic Assessment		EG0000 events0 affected37 at risk EG0014 events4 affected32 at risk
Hypotension	Cardiac disorders	Non-systematic Assessment	Pre, post, or during exercise	EG0001 events1 affected37 at risk EG0010 events0 affected32 at risk
Chest pain and shortness of breath	Cardiac disorders	Non-systematic Assessment	Minor, resolved with rest	EG0001 events1 affected37 at risk EG0010 events0 affected32 at risk
Fatigue	General disorders	Non-systematic Assessment		EG0000 events0 affected37 at risk EG0011 events1 affected32 at risk

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms