Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Fatigue
  • HIV
  • Mobility Limitation
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants will first be randomized to continuous moderate intensity or high-intensity interval training for 16 weeks. After 16 weeks, participants will be re-randomized to 12-week coaching intervention or control.Masking: None (Open Label)Masking Description: Outcomes assessors will be blinded for endpoints, as feasible.Primary Purpose: Other

Participation Requirements

Age
Between 50 years and 125 years
Gender
Both males and females

Description

This is a multi-site, randomized, single-blind (researchers), active treatment concurrent control trial with individuals aged 50-80 living with HIV who experience fatigue and live a sedentary lifestyle. The overall goals of this proposal are to determine whether high-intensity interval training (HII...

This is a multi-site, randomized, single-blind (researchers), active treatment concurrent control trial with individuals aged 50-80 living with HIV who experience fatigue and live a sedentary lifestyle. The overall goals of this proposal are to determine whether high-intensity interval training (HIIT) can overcome physical function impairments and increased fatigue (Aim 1) and impairments in mitochondrial bioenergetics of older people with HIV (PWH) to a greater extent than continuous moderate-intensity exercise (CME) (Aim 2). The investigators further seek to determine whether a biobehavioral coaching intervention following either HIIT or CME can promote long-term adherence to physical activity (Aim 3), a crucial component of the sustainability of the intervention. This study will enroll 200 participants in Aurora, Colorado and Cleveland, Ohio, and includes 20 visits over a one-year period. Data collection will occur at each visit, with baseline data collected at the initial visit. A 3-month follow-up will be conducted over the phone from the date of the final visit. Physical function will be measured by a 400-meter walk test (400MWT) and the short physical performance battery in its original (SPPB) and modified (mSPPB) forms. Fatigue will be measured by the Lee Fatigue Scale (LFS) - a 7-item visual analog self-report scale that asks participants to rate from 0 to 10 how they feel "right now." Mitochondrial bioenergetics will be assessed through blood draws, muscle biopsies and mitochondrial assays. Adherence to physical activity (PA) will be analyzed through ActiGraphy - measurement of PA duration and intensity on three planes of movement captured through PA monitors. Finally, perceptions of PA will be determined through the analysis of qualitative interviews. The hypotheses are that that investigators will see greater changes in mitochondrial bioenergetics with HIIT (AIM 1), and that these changes will be related to improved physical function and fatigue (Aim 2). The investigators expect that HIIT will result in greater exercise satisfaction and likelihood of long-term continuation of exercise (Aim 3). Using a coaching intervention for self-directed exercise that combines motivational interviewing and personalized support during the maintenance phase (Aim 3), the investigators seek to develop the ideal "cocktail" to promote healthspan among older PWH in the current era of ART.

Tracking Information

NCT #
NCT04550676
Collaborators
  • Case Western Reserve University
  • University of Washington
Investigators
Principal Investigator: Kristine Erlandson, MD University of Colorado - Anschutz Medical Campus Principal Investigator: Allison Webel, PhD, RN University of Washington