{"type":"trials","record":{"id":30607,"source_id":"clinicaltrials-gov","external_id":"NCT04550676","title":"High-Intensity Exercise to Attenuate Limitations and Train Habits in Older Adults With HIV","brief_summary":"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 100 participants in Aurora, Colorado and Seattle, Washington. 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. The initial enrollment goal of 100 was increased to 120 in 2023 to facilitate a larger number of participants with key secondary outcomes.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"University of Colorado, Denver","enrollment":118,"countries":["United States"],"start_date":"2021-04-02","completion_date":"2025-11-24","last_update_date":"2026-05-28","source_url":"https://clinicaltrials.gov/study/NCT04550676","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:16.485702+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":"HEALTH","age_range":"50 Years","comparator":"Continuous moderate intensity exercise (CME); Control (following CME); Control (following HIIT)","organization":"University of Colorado, Denver","interventions":["HIIT (intervention)","CME (active control)","Coaching","Control text message"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change in Physical Function (Part 1) — 0-16 weeks","Change in Fatigue (Part 1) — 0-16 weeks"],"design_description":"RANDOMIZED · SEQUENTIAL · OTHER · NONE","source_has_results":true},"controlled_terms":["Hiv","Fatigue","Mobility Limitation","HIIT (intervention)","CME (active control)","Coaching","Control text message"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: exercise.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct04550676","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2021-04-02 to 2025-11-24","comparator":"Continuous moderate intensity exercise (CME); Control (following CME); Control (following HIIT)","confidence":"structured-source","population":"ALL · 50 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:07.429Z","intervention":["HIIT (intervention)","CME (active control)","Coaching","Control text message"],"participants":118,"study_design":"RANDOMIZED · SEQUENTIAL · OTHER · NONE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Change in Physical Function (Part 1) — 0-16 weeks","Change in Fatigue (Part 1) — 0-16 weeks"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"exercise","is_published":true,"match_reasons":["Title contains controlled term: exercise.","Abstract contains controlled term: exercise, physical activity.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Exercise","slug":"exercise"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/30607","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}