Fitness and Longevity in Exercise

Aging Clinical Trial

— FLEX  

Official title:

Fitness and Longevity in Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03399136
• Other study ID #: HP-00042601
• Status: Completed
• Phase: N/A
• Start date: July 19, 2007
• Est. completion date: April 23, 2012

Study information

• Verified date: December 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study objective was to determine the safety and efficacy of aerobic exercise in older HIV-infected men in a randomized trial comparing different levels of exercise intensity.

Description:

The study was a randomized trial of moderate-intensity versus high-intensity aerobic exercise (AEX) training in older HIV-infected adults. Funding was provided by K23 AG024896 (PI, Oursler) and the UMB Claude D. Pepper Older Americans Independence Center P60 AG12583 (PI, Goldberg).

The central hypothesis was that high-intensity AEX training is well-tolerated and significantly increases aerobic capacity in older HIV-infected adults.

The study met its objectives:

1. Scientific AIMS met:

1. High-intensity AEX training significantly increases aerobic capacity

2. Both moderate-intensity and high-intensity AEX training improve ambulatory function and endurance.

3. Activity of skeletal muscle oxidative enzymes is reduced, and associated with aerobic capacity.

2. Feasibility Objectives met:

1. AEX training is safe and well-tolerated in older HIV-infected adults.

2. Skeletal muscle punch biopsy is safe and well-tolerated in older HIV-infected adults.

3. Preliminary data was collected on plasma biomarkers of inflammation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 23, 2012
• Est. primary completion date: October 29, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• HIV+

• stable combination antiretroviral therapy (cART)

Exclusion Criteria:

• AIDS defining conditions in the prior six months

• Conditions that increase the risk of exercise training per the American College of Sports Medicine (ACSM)

Related Conditions & MeSH terms

• Aging
• HIV-1-infection

Intervention

Behavioral:
• Exercise training
Participants attended center-based exercise sessions three times per week at the research exercise training facility located at the Baltimore VA Medical Center. All exercise training was performed under the supervision of research exercise physiologists. Heart rate (HR) was measured continuously during each session using a Polar HR watch and chest strap allowing for assessment and maintenance of treatment fidelity. Exercise logs included details on exercise type, duration, time in target heart rate zone, blood pressure and perceived intensity during each training session.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

References & Publications (1)

Ortmeyer HK, Ryan AS, Hafer-Macko C, Oursler KK. Skeletal muscle cellular metabolism in older HIV-infected men. Physiol Rep. 2016 May;4(9):e12794. doi: 10.14814/phy2.12794. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	skeletal muscle oxidative function	activity of enzymes in oxidative function from muscle biopsy	baseline
Primary	Change from baseline Cardiorespiratory Fitness at 16 weeks	Cardiorespiratory Fitness measured by VO2peak	16-weeks
Secondary	Change from baseline Six-minute walk distance at 16 weeks	Distance walked at normal pace in 6 minutes	16-weeks
Secondary	Change from baseline body composition at 16 weeks	body composition measured as total and regional lean tissue and fat mass (DXA)	16-weeks
Secondary	Change from baseline exercise endurance at 16 weeks	exercise endurance measured as time on treadmill during modified Bruce protocol	16-weeks