The High-Intensity Exercise Study to Attenuate Limitations and Train Habits in Older Adults With HIV (HEALTH): A Research Protocol

Vitor H F Oliveira, Kristine M Erlandson, Paul F Cook, Catherine Jankowski, Samantha MaWhinney, Sahera Dirajlal-Fargo, Leslie Knaub, Chao-Pin Hsiao, Christine Horvat Davey, Allison R Webel, Vitor H F Oliveira, Kristine M Erlandson, Paul F Cook, Catherine Jankowski, Samantha MaWhinney, Sahera Dirajlal-Fargo, Leslie Knaub, Chao-Pin Hsiao, Christine Horvat Davey, Allison R Webel

Abstract

The High-Intensity Exercise Study to Attenuate Limitations and Train Habits in Older Adults With HIV (HEALTH), which incorporates an exercise and biobehavioral coaching intervention, has the following overall goals: (a) to determine whether high-intensity interval training (HIIT) mitigates physical function impairments, fatigue, and impairments in mitochondrial bioenergetics of older people living with HIV (PLWH) to a greater extent than continuous moderate exercise (CME); and (b) to determine whether a biobehavioral coaching and mobile health text messaging intervention after HIIT or CME can promote long-term adherence to physical activity. The HEALTH study is a randomized trial of 100 older PLWH (≥50 years of age) who self-report fatigue and have a sedentary lifestyle. Enrolled participants will be randomized to 16 weeks of supervised HIIT or CME training, followed by a 12-week maintenance phase, involving a mobile health coaching intervention. Outcomes of the HEALTH study will inform the development of scalable, effective exercise recommendations tailored to the unique needs of aging PLWH.

Trial registration: ClinicalTrials.gov NCT04550676.

Copyright © 2021 Association of Nurses in AIDS Care.

Figures

Figure 1.
Figure 1.
HEALTH study procedures flowchart. Note. *Given the potential for dropout, the second randomization will be conducted at week 16 and will also be balanced by initial randomization (2×2 factorial design). 1-RM = one-repetition maximum test; DXA = dual-energy absorptiometry scan; GXT = graded exercise test; PA = physical activity; VO2 = difference between oxygen inspired and oxygen expired in a unit of time.
Figure 2.
Figure 2.
Visual scheme of HEALTH study procedures. Note. HIIT and CME will be matched for caloric expenditure. The first weeks of exercise training (weeks 1 to 8) will focus on familiarization; intensity and duration of exercises will progress over the first 8 weeks to reach the target goals, and this prescription will be maintained until the end of the intervention. From weeks 8 to 16, the aerobic exercise duration will be 42 minutes for HIIT and 50 minutes for CME (main part plus warm-up and cool down). Given the potential for dropout, the second randomization will be conducted at week 16 and will also be balanced by initial randomization (2×2 factorial design). 1-RM = one-repetition maximum test; CME = continuous moderate exercise; DXA = dual-energy absorptiometry scan; GXT = graded exercise test; HIIT = high-intensity interval training; HRR= heart rate reserve; PA = physical activity; VO2 = difference between oxygen inspired and oxygen expired in a unit of time.

References

    1. Briggs BC, Ryan AS, Sorkin JD, & Oursler KK (2020). Feasibility and effects of high-intensity interval training in older adults living with HIV. Journal of Sports Sciences, 00(00), 1–8. 10.1080/02640414.2020.1818949
    1. Cook PF, Carrington JM, Schmiege SJ, Starr W, & Reeder B (2015). A counselor in your pocket: Feasibility of mobile health tailored messages to support HIV medication adherence. Patient Preference and Adherence, 9, 1353–1366. 10.2147/PPA.S88222
    1. Cook PF, Schmiege SJ, Reeder B, Horton-Deutsch S, Lowe NK, & Meek P (2018). Temporal Immediacy: A Two-System Theory of Mind for Understanding and Changing Health Behaviors. Nursing Research, 67(2), 108–121. 10.1097/NNR.0000000000000265
    1. Dun Y, Smith JR, Liu S, & Olson TP (2019). High-Intensity Interval Training in Cardiac Rehabilitation. Clinics in Geriatric Medicine, 35(4), 469–487. 10.1016/j.cger.2019.07.011
    1. Erlandson KM, Allshouse AA, Jankowski CM, Mawhinney S, Kohrt WM, & Campbell TB (2014). Relationship of physical function and quality of life among persons aging with HIV infection. AIDS, 28(13), 1939–1943. 10.1097/QAD.0000000000000384
    1. Erlandson KM, MaWhinney S, Wilson M, Gross L, McCandless SA, Campbell TB, Kohrt WM, Schwartz R, Brown TT, & Jankowski CM (2018). Physical function improvements with moderate or high-intensity exercise among older adults with or without HIV infection. AIDS, 32(16), 1. 10.1097/QAD.0000000000001984
    1. Evans WJ, Phinney SD, & Young VR (1982). Suction applied to a muscle biopsy maximizes sample size. Medicine and Science in Sports and Exercise, 14(1), 101–102.
    1. Forster JE, MaWhinney S, Ball EL, & Fairclough D (2012). A varying-coefficient method for analyzing longitudinal clinical trials data with nonignorable dropout. Contemporary Clinical Trials, 33(2), 378–385. 10.1016/j.cct.2011.11.009
    1. Fried LPP, Tangen CMM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, & McBurnie MA (2001). Frailty in Older Adults: Evidence for a Phenotype. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences, 56(3), M146–M157. 10.1093/gerona/56.3.M146
    1. Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, & Wallace RB (1994). A Short Physical Performance Battery Assessing Lower Extremity Function: Association With Self-Reported Disability and Prediction of Mortality and Nursing Home Admission. Journal of Gerontology, 49(2), M85–M94. 10.1093/geronj/49.2.M85
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, & Conde JG (2009). Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support. Journal of Biomedical Informatics, 42(2), 377–381. 10.1016/j.jbi.2008.08.010
    1. Jong E, Oudhoff LA, Epskamp C, Wagener MN, van Duijn M, Fischer S, & van Gorp EC (2010). Predictors and treatment strategies of HIV-related fatigue in the combined antiretroviral therapy era. AIDS, 24(10), 1387–1405. 10.1097/QAD.0b013e328339d004
    1. Lee KA, Hicks G, & Nino-Murcia G (1991). Validity and reliability of a scale to assess fatigue. Psychiatry Research, 36(3), 291–298. 10.1016/0165-1781(91)90027-M
    1. Lundahl B, Moleni T, Burke BL, Butters R, Tollefson D, Butler C, & Rollnick S (2013). Motivational interviewing in medical care settings: A systematic review and meta-analysis of randomized controlled trials. Patient Education and Counseling, 93(2), 157–168. 10.1016/j.pec.2013.07.012
    1. Marcus JL, Leyden WA, Alexeeff SE, Anderson AN, Hechter RC, Hu H, Lam JO, Towner WJ, Yuan Q, Horberg MA, & Silverberg MJ (2020). Comparison of Overall and Comorbidity-Free Life Expectancy Between Insured Adults With and Without HIV Infection, 2000–2016. JAMA Network Open, 3(6), e207954. 10.1001/jamanetworkopen.2020.7954
    1. Maula A, LaFond N, Orton E, Iliffe S, Audsley S, Vedhara K, & Kendrick D (2019). Use it or lose it: A qualitative study of the maintenance of physical activity in older adults. BMC Geriatrics, 19(1), 349. 10.1186/s12877-019-1366-x
    1. Migueles JH, Cadenas-Sanchez C, Ekelund U, Delisle Nyström C, Mora-Gonzalez J, Löf M, Labayen I, Ruiz JR, & Ortega FB (2017). Accelerometer Data Collection and Processing Criteria to Assess Physical Activity and Other Outcomes: A Systematic Review and Practical Considerations. Sports Medicine, 47(9), 1821–1845. 10.1007/s40279-017-0716-0
    1. Milanini B, Catella S, Perkovich B, Esmaeili-Firidouni P, Wendelken L, Paul R, Greene M, Ketelle R, & Valcour V (2017). Psychiatric symptom burden in older people living with HIV with and without cognitive impairment: The UCSF HIV over 60 cohort study. AIDS Care, 29(9), 1178–1185. 10.1080/09540121.2017.1281877
    1. Moore CM, MaWhinney S, Forster JE, Carlson NE, Allshouse A, Wang X, Routy J-P, Conway B, & Connick E (2017). Accounting for dropout reason in longitudinal studies with nonignorable dropout. Statistical Methods in Medical Research, 26(4), 1854–1866. 10.1177/0962280215590432
    1. Noar SM, Benac CN, & Harris MS (2007). Does tailoring matter? Meta-analytic review of tailored print health behavior change interventions. Psychological Bulletin, 133(4), 673–693. 10.1037/0033-2909.133.4.673
    1. Oikonomidi T, Vivot A, Tran V-T, Riveros C, Robin E, & Ravaud P (2019). A Methodologic Systematic Review of Mobile Health Behavior Change Randomized Trials. American Journal of Preventive Medicine, 57(6), 836–843. 10.1016/j.amepre.2019.07.008
    1. Oliveira VH, Wiechmann SL, Narciso AM, Webel AR, & Deminice R (2017). Muscle strength is impaired in men but not in women living with HIV taking antiretroviral therapy. Antiviral Therapy, 23(1), 11–19. 10.3851/IMP3159
    1. Pattyn N, Vanhees L, Cornelissen VA, Coeckelberghs E, De Maeyer C, Goetschalckx K, Possemiers N, Wuyts K, Van Craenenbroeck EM, & Beckers PJ (2016). The long-term effects of a randomized trial comparing aerobic interval versus continuous training in coronary artery disease patients: 1-year data from the SAINTEX-CAD study. European Journal of Preventive Cardiology, 23(11), 1154–1164. 10.1177/2047487316631200
    1. Pesta D, & Gnaiger E (2012). High-resolution respirometry: OXPHOS protocols for human cells and permeabilized fibers from small biopsies of human muscle. Methods in Molecular Biology, 810, 25–58. 10.1007/978-1-61779-382-0_3
    1. Piercy KL, Troiano RP, Ballard RM, Carlson SA, Fulton JE, Galuska DA, George SM, & Olson RD (2018). The Physical Activity Guidelines for Americans. JAMA, 320(19), 2020. 10.1001/jama.2018.14854
    1. Riebe D, Ehrman JK, Liguori G, & Magal M (2018). ACSM’s guidelines for exercise testing and prescription (10th ed.). Wolters Kluwer.
    1. Robinson MM, Dasari S, Konopka AR, Johnson ML, Manjunatha S, Esponda RR, Carter RE, Lanza IR, & Nair KS (2017). Enhanced Protein Translation Underlies Improved Metabolic and Physical Adaptations to Different Exercise Training Modes in Young and Old Humans. Cell Metabolism, 25(3), 581–592. 10.1016/j.cmet.2017.02.009
    1. Ross LM, Porter RR, & Durstine JL (2016). High-intensity interval training (HIIT) for patients with chronic diseases. Journal of Sport and Health Science, 5(2), 139–144. 10.1016/j.jshs.2016.04.005
    1. Rubin DB (1996). Multiple Imputation after 18+ Years. Journal of the American Statistical Association, 91(434), 473–489. 10.1080/01621459.1996.10476908
    1. Sasaki JE, John D, & Freedson PS (2011). Validation and comparison of ActiGraph activity monitors. Journal of Science and Medicine in Sport, 14(5), 411–416. 10.1016/j.jsams.2011.04.003
    1. Schafer JL (1999). Multiple imputation: a primer. Statistical Methods in Medical Research, 8(1), 3–15. 10.1177/096228029900800102
    1. Schrack JA, Jacobson LP, Althoff KN, Erlandson KM, Jamieson BD, Koletar SL, Phair J, Brown TT, & Margolick JB (2016). Effect of HIV-infection and cumulative viral load on age-related decline in grip strength. AIDS, 30(17), 2645–2652. 10.1097/QAD.0000000000001245
    1. Schreiner N, Perazzo J, Digennaro S, Burant C, Daly B, & Webel A (2020). Associations between symptom severity and treatment burden in people living with HIV. Journal of Advanced Nursing, 76(9), 2348–2358. 10.1111/jan.14461
    1. Simonsick EM, Newman AB, Nevitt MC, Kritchevsky SB, Ferrucci L, Guralnik JM, & Harris T (2001). Measuring Higher Level Physical Function in Well-Functioning Older Adults: Expanding Familiar Approaches in the Health ABC Study. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences, 56(10), M644–M649. 10.1093/gerona/56.10.M644
    1. Smit M, Brinkman K, Geerlings S, Smit C, Thyagarajan K, van Sighem AV, de Wolf F, & Hallett TB (2015). Future challenges for clinical care of an ageing population infected with HIV: A modelling study. The Lancet Infectious Diseases, 15(7), 810–818. 10.1016/S1473-3099(15)00056-0
    1. Spinazzi M, Casarin A, Pertegato V, Salviati L, & Angelini C (2012). Assessment of mitochondrial respiratory chain enzymatic activities on tissues and cultured cells. Nature Protocols, 7(6), 1235–1246. 10.1038/nprot.2012.058
    1. Toohey K, Pumpa K, McKune A, Cooke J, DuBose KD, Yip D, Craft P, & Semple S (2018). Does low volume high-intensity interval training elicit superior benefits to continuous low to moderate-intensity training in cancer survivors? World Journal of Clinical Oncology, 9(1), 1–12. 10.5306/wjco.v9.i1.1
    1. van Stralen MM, De Vries H, Mudde AN, Bolman C, & Lechner L (2009). Determinants of initiation and maintenance of physical activity among older adults: A literature review. Health Psychology Review, 3(2), 147–207. 10.1080/17437190903229462
    1. Yang M, Keller S, & Lin J-MS (2019). Psychometric properties of the PROMIS® Fatigue Short Form 7a among adults with myalgic encephalomyelitis/chronic fatigue syndrome. Quality of Life Research, 28(12), 3375–3384. 10.1007/s11136-019-02289-4
    1. Yang S, Chu S, Gao Y, Ai Q, Liu Y, Li X, & Chen N (2019). A Narrative Review of Cancer-Related Fatigue (CRF) and Its Possible Pathogenesis. Cells, 8(7), 738. 10.3390/cells8070738

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe