NCT02404792

Brief Summary

The primary objective of this proposal is to compare a moderate or high intensity exercise intervention to improve physical function in persons aging with Human Immunodeficiency Virus (HIV).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 18, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 16, 2019

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

2.5 years

First QC Date

March 18, 2015

Results QC Date

October 9, 2018

Last Update Submit

January 15, 2019

Conditions

HIVInflammationObesityAging, Biological

Keywords

Frail ElderlyIGF-1

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

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

    24 weeks

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

    Baseline and 24 weeks

Study Arms (2)

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 exerciseOther: 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 exerciseOther: Moderate-intensity cardiovascular and resistance exercise

Interventions

High-intensity cardiovascular and resistance exerciseOTHER
HIV-infectedHIV-uninfected
Moderate-intensity cardiovascular and resistance exerciseOTHER
HIV-infectedHIV-uninfected

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado- Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (6)

  • 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.

    PMID: 40134456DERIVED

  • 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.

    PMID: 35302400DERIVED

  • Erlandson KM, Liu J, Johnson R, Dillon S, Jankowski CM, Kroehl M, Robertson CE, Frank DN, Tuncil Y, Higgins J, Hamaker B, Wilson CC. An exercise intervention alters stool microbiota and metabolites among older, sedentary adults. Ther Adv Infect Dis. 2021 Jun 25;8:20499361211027067. doi: 10.1177/20499361211027067. eCollection 2021 Jan-Dec.

    PMID: 34262758DERIVED

  • Jankowski CM, Wilson MP, MaWhinney S, Reusch J, Knaub L, Hull S, Erlandson KM. Blunted Muscle Mitochondrial Responses to Exercise Training in Older Adults With HIV. J Infect Dis. 2021 Aug 16;224(4):679-683. doi: 10.1093/infdis/jiaa799.

    PMID: 33378424DERIVED

  • Erlandson KM, Wilson MP, MaWhinney S, Rapaport E, Liu J, Wilson CC, Rahkola JT, Janoff EN, Brown TT, Campbell TB, Jankowski CM. The Impact of Moderate or High-Intensity Combined Exercise on Systemic Inflammation Among Older Persons With and Without HIV. J Infect Dis. 2021 Apr 8;223(7):1161-1170. doi: 10.1093/infdis/jiaa494.

    PMID: 32779711DERIVED

  • Johs NA, Kellar-Guenther Y, Jankowski CM, Neff H, Erlandson KM. A qualitative focus group study of perceived barriers and benefits to exercise by self-described exercise status among older adults living with HIV. BMJ Open. 2019 Mar 7;9(3):e026294. doi: 10.1136/bmjopen-2018-026294.

    PMID: 30850416DERIVED

MeSH Terms

Conditions

InflammationObesity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Results Point of Contact

Title
Kristine Erlandson (PI)
Organization
University of Colorado
kristine.erlandson@ucdenver.edu
303-724-4941

Study Officials

  • Kristine Erlandson, MD, MSc

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2015

First Posted

April 1, 2015

Study Start

April 1, 2015

Primary Completion

October 2, 2017

Study Completion

March 1, 2018

Last Updated

January 16, 2019

Results First Posted

January 16, 2019

Record last verified: 2019-01

Locations

US(1)