Fitness and Longevity in Exercise

NCT03399136 | Completed

• 1 other identifier: HP-00042601
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV-1-infection; Aging

Keywords

Exercise training; Intervention; Aerobic capacity

Outcome Measures

Primary Outcomes (1)

• Change from baseline Cardiorespiratory Fitness at 16 weeks

  Cardiorespiratory Fitness measured by VO2peak

  16-weeks

Secondary Outcomes (3)

• Change from baseline Six-minute walk distance at 16 weeks

  16-weeks

• Change from baseline body composition at 16 weeks

  16-weeks

• Change from baseline exercise endurance at 16 weeks

  16-weeks

Other Outcomes (1)

• skeletal muscle oxidative function

  baseline

Study Arms (2)

Moderate-intensity aerobic exercise

EXPERIMENTAL

In the moderate-intensity aerobic exercise group, participants performed a self-paced 1-mile walk (3-5 METs) on an indoor track in the same exercise center as the high-intensity exercise group. Initial sessions lasted 20-30 minutes and were increased weekly to 45 minutes in parallel to the duration of the high-intensity exercise group.

Behavioral: Exercise training

High-intensity aerobic exercise

EXPERIMENTAL

In the high-intensity aerobic exercise group, exercise training was performed on a motorized treadmill with occasional substitution with the elliptical machine as needed for joint pain. Target heart rate was based on the baseline treadmill test and was calculated as percentage of the heart rate reserve (HRR=maximal HR-resting HR). Initially, participants trained for 20-30 minutes at 50-60% of HRR. Duration and intensity was increased by 10% weekly so that within 5-7 weeks the aerobic exercise sessions lasted 30-45 minutes at 70-85% of HRR and at the end of the 16 weeks lasted 40-45 minutes at 75-90% of HRR.

Behavioral: Exercise training

Interventions

Exercise training BEHAVIORAL

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.

High-intensity aerobic exercise; Moderate-intensity aerobic exercise

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV+
• stable combination antiretroviral therapy (cART)

You may not qualify if:

• AIDS defining conditions in the prior six months
• Conditions that increase the risk of exercise training per the American College of Sports Medicine (ACSM)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Related 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.

  PMID: 27166139 RESULT

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Krisann Oursler, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 16, 2018
• Study Start: July 19, 2007
• Primary Completion: October 29, 2010
• Study Completion: April 23, 2012
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share