NCT04550676Befejeződött
High-Intensity Exercise to Attenuate Limitations and Train Habits in Older Adults With HIV
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 28.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 118 (tényleges)
- Első benyújtás
- 2020. szept. 10.
- Kezdés
- 2021. ápr. 2.
- Elsődleges befejezés
- 2025. jan. 24.
- Fő szponzor
- University of Colorado, Denver
- Betegségek
- HIV-fertőzés
- NCT-szám
- NCT04550676
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 118
- 2021. ápr. 2. és az elsődleges befejezés (2025. jan. 24.) között
- 3 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Use of sex hormone therapy, if on for ≤3 months (stable doses for \>3 months will be permitted)
- Diagnosis of mitochondrial disease For participants undergoing the muscle biopsy only, use of anticoagulant therapy other than low dose aspirin that cannot be held for at least 7 days for the muscle biopsy. Aspirin and non-steroidal use will be permitted but will be held for 7 days prior to the muscle biopsy, and can be resumed following the biopsy.
- Malignancy requiring chemotherapy or radiation therapy within 24 weeks prior to enrollment,
- Surgery/trauma/injury/fracture within 24 weeks prior to enrollment that, in the opinion of the study physician, may impact a subject's baseline functional testing and ability to exercise,
Más betegség
- Due to the expected fatigue associated with COVID-19 and potential infection risk, anyone with a diagnosis of COVID will not be eligible for enrollment until at least 30 days after symptom resolution and return to baseline level of function.
- Uncontrolled hypertension defined as resting systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg; participants who do not meet these criteria at first screening will be re-evaluated, including follow-up evaluation by their primary care provider with initiation or adjustment of anti-hypertensive medications,
- Unstable ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the graded exercise test without negative follow-up evaluation will be cause for exclusion; follow-up evaluation must include diagnostic testing (e.g., thallium stress test) with interpretation by a cardiologist,
- New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, uncontrolled angina, or uncontrolled arrhythmia,
- Pulmonary disease requiring the use of supplemental oxygen at rest or with physical exertion,
Laborértékek
- Anemia (Hemoglobin ≤9 g/dL for women or ≤10 g/dL for men) due to contribution to fatigue,
- Poorly controlled diabetes, as evidenced by hemoglobin A1c \> 8.0, documented within 6 months of study visit,
Egyéb
- Weight over 450 pounds (due to limitations of the DXA machine)
- Use of other hormone replacement, if on for ≤ 3 months (stable doses \>3 months will be permitted)
- Active substance abuse or other factors that could prevent compliance or safety with study visits, at the discretion of the site investigator,
- Reasons for medical exclusion, as determined by study PIs:
- Balance impairments that may impact functional testing and ability to safely exercise as reported by the participant or in their medical record,
- 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),
- Persons who, in the judgment of the study physician, appear to have unstable health or are incapable of safely participating in the exercise intervention.
Kiket keres a vizsgálat
- Aged ≥ 50years,
- Sedentary lifestyle, defined by self-reported physical activity that breaks a sweat \<3 days/week, with no regular resistance exercise for 3 months preceding study,
- Fatigued (≥2.0 on either of the first two screening items on the HIV-Related Fatigue Scale),
- HIV infection, on prescribed HIV antiretroviral therapy for ≥ 12 months, with no current use (within 1 year) of older drugs with established mitochondrial toxicity (i.e., D4T, DDI, ZDV),
- HIV-1 RNA level \< 200 copies/mL, for a minimum of 12 months prior to enrollment, with an allowed blip to 500 copies/mL presuming repeat assessments are below 200 copies,
- Willing to participate in either assigned arm of a 16-week supervised exercise intervention 3 times weekly,
- Thyroid Stimulating Hormone (TSH) within normal lab limits-Cell phone with ability to receive text messaging in order to participate in the biobehavioral maintenance intervention or ability to access to email daily
- Ability and willingness of participant to provide informed consent and consent for access to medical record
- COVID-19 vaccination and appropriate boosters received
Életkor a regiszterben: 50 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (3)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Aurora | Egyesült Államok | Ismeretlen állapot |
| Part 2 of the Study (both CO and WA) Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Aurora | Egyesült Államok | Ismeretlen állapot |
| University of Washington Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Seattle | Egyesült Államok | Ismeretlen állapot |
Kapcsolódó publikációk
- Efficacy of Tailored Messages for 28-Week Exercise Sustainability in People with HIV.AIDS Behav · 2026 · PMID 42814385
- The Impact of Social Vulnerability on Exercise Outcomes: A Longitudinal Study of Physical Function in Older People With HIV.J Int Assoc Provid AIDS Care · 2026 · PMID 42124323
- The effects of high-intensity interval training versus continuous moderate-intensity exercise on body composition among older adults with HIV.J Gerontol A Biol Sci Med Sci · 2026 · PMID 42080214
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