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Open Access 01-12-2013 | Study protocol

A home-based exercise intervention to increase physical activity among people living with HIV: study design of a randomized clinical trial

Authors: Jason R Jaggers, Wesley Dudgeon, Steven N Blair, Xuemei Sui, Stephanie Burgess, Sara Wilcox, Gregory A Hand

Published in: BMC Public Health | Issue 1/2013

Abstract

Background

While combination antiretroviral therapy has extended the life expectancy of those infected with human immunodeficiency virus (HIV), there is a high prevalence of comorbidities that increase the risk of cardiovascular morbidity and mortality among people living with HIV/AIDS (PLWHA). The side effects associated with antiretroviral therapy (ART) lead to multiple metabolic disorders, making the management of these metabolic issues and risk of cardiovascular disease (CVD) in those treated with ART a critical issue. Clinical research trials, primarily clinical exercise, rarely include this population due to unique challenges in research methods with underserved minority populations living with a life threatening illness like HIV/AIDS. This paper describes the rationale and design of a randomized clinical trial evaluating the feasibility of a home-based exercise program designed to increase physical activity (PA) and reduce the risk of CVD in PLWHA.

Methods/design

PLWHA being treated with ART will be randomly assigned to one of two groups: a home-based PA intervention or standard care. All participants will receive an educational weight loss workbook and pedometer for self-monitoring of PA. Only those in the intervention group will receive additional elastic Thera-bands® for strength training and behavioral telephone based coaching.

Discussion

This study will evaluate the feasibility of a home-based program designed to increase PA among PLWHA. Further, it will evaluate the effectiveness of such a program to decrease modifiable risk factors for CVD as a secondary outcome. This study was funded by the NIH/NINR R21 Grant 1R21NRO11281.

Trial registration

Clinical Trial Identifier NCT01377064

Available only for authorised users

Friis-Moller N, Sabin CA, Weber R, d’Arminio MA, El-Sadr WM, Reiss P: Combination antiretroviral therapy and the risk of myocardial infarction. N Engl J Med. 2003, 349 (21): 1993-2003.CrossRefPubMed

Triant VA, Lee H, Hadigan C, Grinspoon SK: Increased acute myocardial infarction rates and cardiovascular risk factors among patients with human immunodeficiency virus disease. J Clin Endocrinol Metab. 2007, 92 (7): 2506-2512. 10.1210/jc.2006-2190.CrossRefPubMedPubMedCentral

Anuurad E, Semrad A, Berglund L: Human immunodeficiency virus and highly active antiretroviral therapy-associated metabolic disorders and risk factors for cardiovascular disease. Metab Syndr Relat Disord. 2009, 7 (5): 401-410. 10.1089/met.2008.0096.CrossRefPubMedPubMedCentral

Thompson V, Medard B, Taseera K, Chakera AJ, Andia I, Emenyonu N, Hunt PW, Martin J, Scherzer R, Weiser SD, Bangsberg DR, Tien PC: Regional anthropometry changes in antiretroviral-naive persons initiating a Zidovudine-containing regimen in Mbarara. Uganda. AIDS Res Hum Retrov. 2011, 27 (7): 785-791. 10.1089/aid.2010.0272.CrossRef

United States. Dept. of Health and Human Services: 2008 physical activity guidelines for Americans: be active, healthy, and happy! ODPHP publication no. U0036. 2008, Washington, DC: U.S: Dept. of Health and Human Services, 61. ix-

Hand GA, Phillips KD, Dudgeon WD, Lyerly GW, Durstine JL, Burgess SE: Moderate intensity exercise training reverses functional aerobic impairment in HIV-infected individuals. AIDS Care. 2008, 20 (9): 1066-1074. 10.1080/09540120701796900.CrossRefPubMed

Blair SN, Kampert JB, Kohl HW, Barlow CE, Macera CA, Paffenberger RS, Gibbons LW: Influences of cardiorespiratory fitness and other precursors on cardiovascular disease and all-cause mortality in men and women. JAMA. 1996, 276 (3): 205-210. 10.1001/jama.1996.03540030039029.CrossRefPubMed

Lee CD, Blair SN, Jackson AS: Cardiorespiratory fitness, body composition, and all-cause and cardiovascular disease mortality in men. Am J Clin Nutr. 1999, 69 (3): 373-380.PubMed

Wei M, Gibbons LW, Kampert JB, Nichaman MZ, Blair SN: Low cardiorespiratory fitness and physical inactivity as predictors of mortality in men with type 2 diabetes. Ann Intern Med. 2000, 132 (8): 605-611.CrossRefPubMed

10.

MacArthur RD, Levine SD, Birk TJ: Supervised exercise training improves cardiopulmonary fitness in HIV-infected persons. Med Sci Sports Exerc. 1993, 25 (6): 684-688.CrossRefPubMed

11.

Jones SP, Doran DA, Leatt PB, Maher B, Pirmohamed M: Short-term exercise training improves body composition and hyperlipidaemia in HIV-positive individuals with lipodystrophy. AIDS. 2001, 15 (15): 2049-2051. 10.1097/00002030-200110190-00021.CrossRefPubMed

12.

Thoni GJ, Fedou C, Brun JF, Fabre J, Renard E, Reynes J, Varray A, Mercier J: Reduction of fat accumulation and lipid disorders by individualized light aerobic training in human immunodeficiency virus infected patients with lipodystrophy and/or dyslipidemia. Diabetes Metab. 2002, 28 (5): 397-404.PubMed

13.

Roubenoff R, Weiss L, McDermott A, Heflin T, Cloutier GJ, Wood M, Sherwood G: A pilot study of exercise training to reduce trunk fat in adults with HIV-associated fat redistribution. AIDS. 1999, 13 (11): 1373-1375. 10.1097/00002030-199907300-00015.CrossRefPubMed

14.

Jurca R, Lamonte MJ, Barlow CE, Kampert JB, Church TS, Blair SN: Association of muscular strength with incidence of metabolic syndrome in men. Med Sci Sports Exerc. 2005, 37 (11): 1849-1855. 10.1249/01.mss.0000175865.17614.74.CrossRefPubMed

15.

Ruiz JR, Sui X, Lobelo F, Morrow JR, Jackson AW, Sjostrom M, Blair SN: Association between muscular strength and mortality in men: prospective cohort study. BMJ. 2008, 337: a439-10.1136/bmj.a439.CrossRefPubMedPubMedCentral

16.

Blair SN, Applegate WB, Dunn AL, Ettinger WH, Haskell WL, King AC, Morgan TM, Shih JH, Simons-Morton DG: Activity counseling trial (ACT): rationale, design, and methods. Activity counseling trial research group. Med Sci Sports Exerc. 1998, 30 (7): 1097-1106. 10.1097/00005768-199807000-00012.CrossRefPubMed

17.

Wilcox S, Dowda M, Leviton LC, Bartlett-Prescott J, Bazzarre T, Campbell-Voytal K, Carpenter RA, Castro CM, Dowdy D, Dunn AL, Griffin SF, Guerra M, King AC, Ory MG, Rheaume C, Tobnick J, Wegley S: Active for life: final results from the translation of two physical activity programs. Am J Prev Med. 2008, 35 (4): 340-351. 10.1016/j.amepre.2008.07.001.CrossRefPubMed

18.

Parra-Medina D, Wilcox S, Salinas J, Addy C, Fore E, Poston M, Wilson DK: Results of the heart healthy and ethnically relevant lifestyle trial: a cardiovascular risk reduction intervention for african american women attending community health centers. Am J Public Health. 2011, 101 (10): 1914-1921. 10.2105/AJPH.2011.300151.CrossRefPubMedPubMedCentral

19.

Adamopoulos S, Parissis J, Karatzas D, Kroupis C, Georgiadis M, Karavolias G, Paraskevaidis J, Koniavitou K, Andrew J, Coats S, Kremastinos DT: Physical training modulates proinflammatory cytokines and the soluble Fas/soluble Fas ligand system in patients with chronic heart failure. J Am Coll Cardiol. 2002, 39 (4): 653-663. 10.1016/S0735-1097(01)01795-8.CrossRefPubMed

20.

Behnke M, Jorres RA, Kirsten D, Magnussen H: Clinical benefits of a combined hospital and home-based exercise programme over 18 months in patients with severe COPD. Monaldi Arch Chest Dis. 2003, 59 (1): 44-51.PubMed

21.

Matthews CE, Wilcox S, Handby CL, Der AC, Heiney SP, Gebretsadik T, Ayumi S: Evaluation of a 12-week home-based walking intervention for breast cancer survivors. Support Care Cancer. 2007, 15 (2): 203-211. 10.1007/s00520-006-0122-x.CrossRefPubMed

22.

Niebauer J, Clark AL, Webb-Peploe KM, Coats AJ: Exercise training in chronic heart failure: effects on pro-inflammatory markers. Eur J Heart Fail. 2005, 7 (2): 189-193. 10.1016/j.ejheart.2004.07.012.CrossRefPubMed

23.

Dracup K, Evangelista LS, Hamilton MA, Erickson V, Hage A, Moriguchi J, Canary C, Maclellan RW, Fonarow GC: Effects of a home-based exercise program on clinical outcomes in heart failure. Am Heart J. 2007, 154 (5): 877-883. 10.1016/j.ahj.2007.07.019.CrossRefPubMed

24.

Pinto BM, Frierson GM, Rabin C, Trunzo JJ, Marcus BH: Home-based physical activity intervention for breast cancer patients. J Clin Oncol. 2005, 23 (15): 3577-3587. 10.1200/JCO.2005.03.080.CrossRefPubMed

25.

Eakin EG, Lawler SP, Vandelanotte C, Owen N: Telephone interventions for physical activity and dietary behavior change: a systematic review. Am J Prev Med. 2007, 32 (5): 419-434. 10.1016/j.amepre.2007.01.004.CrossRefPubMed

26.

Hersey JC, Khavjou O, Strange LB, Atkinson RL, Blair SN, Campbell S, Hobbs CL, Kelly B, Fitzgerald TM, Kish-Doto J, Koch MA, Munoz B, Peele E, Stockdale J, Augustine C, Mitchell G, Arday D, Kugler J, Dorn P, Ellzy J, Julian R, Grissom J, Britt M: The efficacy and cost-effectiveness of a community weight management intervention: a randomized controlled trial of the health weight management demonstration. Prev Med. 2012, 54 (1): 42-49. 10.1016/j.ypmed.2011.09.018.CrossRefPubMed

27.

Fruin ML, Rankin JW: Validity of a multi-sensor armband in estimating rest and exercise energy expenditure. Med Sci Sports Exerc. 2004, 36 (6): 1063-1069. 10.1249/01.MSS.0000128144.91337.38.CrossRefPubMed

28.

Papazoglou D, Augello G, Tagliaferri M, Savia G, Marzullo P, Maltezos E, Liuzzi A: Evaluation of a multisensor armband in estimating energy expenditure in obese individuals. Obesity (Silver Spring). 2006, 14 (12): 2217-2223. 10.1038/oby.2006.260.CrossRef

29.

Welk GJ, McClain JJ, Eisenmann JC, Wickel EE: Field validation of the MTI Actigraph and BodyMedia armband monitor using the IDEEA monitor. Obesity (Silver Spring). 2007, 15 (4): 918-928. 10.1038/oby.2007.624.CrossRef

30.

St-Onge M, Mignault D, Allison DB, Rabasa-Lhoret R: Evaluation of a portable device to measure daily energy expenditure in free-living adults. Am J Clin Nutr. 2007, 85 (3): 742-749.PubMed

31.

Bandura A: Social foundations of thought and action: a social cognitive theory. 1986, Englewood Cliffs, NJ: Prentice-Hall

32.

Prochaska JO, DiClemente CC, Norcross JC: In search of how people change. Applications to addictive behaviors. Am Psychol. 1992, 47 (9): 1102-1114.CrossRefPubMed

33.

Skinner JS, Wilmore KM, Jaskolska A, Daw EW, Rice T, Gagnon J, Leon AS, Wilmore JH, Rao DC, Bouchard C: Reproducibility of maximal exercise test data in the HERITAGE family study. Med Sci Sports Exerc. 1999, 31 (11): 1623-1628. 10.1097/00005768-199911000-00020.CrossRefPubMed

34.

Janssen I, Heymsfield SB, Allison DB, Kotler DP, Ross R: Body mass index and waist circumference independently contribute to the prediction of nonabdominal, abdominal subcutaneous, and visceral fat. Am J Clin Nutr. 2002, 75 (4): 683-688.PubMed

35.

Skinner HA: The drug abuse screening test. Addict Behav. 1982, 7 (4): 363-371. 10.1016/0306-4603(82)90005-3.CrossRefPubMed

36.

Skinner HA, Sheu WJ: Reliability of alcohol use indices. The lifetime drinking history and the MAST. J Stud Alcohol. 1982, 43 (11): 1157-1170.CrossRefPubMed

37.

Cohen S, Kamarck T, Mermelstein R: A global measure of perceived stress. J Health Soc Behav. 1983, 24 (4): 385-396. 10.2307/2136404.CrossRefPubMed

38.

McHorney CA, Ware JE, Lu JF, Sherbourne CD: The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994, 32 (1): 40-66. 10.1097/00005650-199401000-00004.CrossRefPubMed

39.

McHorney CA, Ware JE, Raczek AE: The MOS 36-item short-form health survey (SF-36): II. Sychometric and clinical tests of validity in measuring physical and mental health constructs. PMed Care. 1993, 31 (3): 247-263. 10.1097/00005650-199303000-00006.CrossRef

40.

Holmes WC, Ruocco JE: Test-retest evaluation of HAT-QoL and SF-36 in an HIV-seropositive sample. AIDS Care. 2008, 20 (9): 1084-1092. 10.1080/09540120701797437.CrossRefPubMed

41.

Schroevers MJ, Sanderman R, Van SE, Ranchor AV: The evaluation of the center for epidemiologic studies depression (CES-D) scale: depressed and positive affect in cancer patients and healthy reference subjects. Qual Life Res. 2000, 9 (9): 1015-1029. 10.1023/A:1016673003237.CrossRefPubMed

42.

Weissman MM, Sholomskas D, Pottenger M, Prusoff BA, Locke BZ: Assessing depressive symptoms in five psychiatric populations: a validation study. Am J Epidemiol. 1977, 106 (3): 203-214.PubMed

43.

Garcia AW, King AC: Predicting long-term adherence to aerobic exercise - a comparison of 2 models. J Sport Exer Psychol. 1991, 13 (4): 394-410.

44.

Wilcox S, Sharpe PA, Hutto B, Granner ML: Psychometric properties of the self-efficacy for exercise questionnaire in a diverse sample of men and women. J Phys Act Health. 2005, 2: 285-297.

45.

Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nadar PR: The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987, 16 (6): 825-836. 10.1016/0091-7435(87)90022-3.CrossRefPubMed

46.

Rovniak LS, Anderson ES, Winett RA, Stephens RS: Social cognitive determinants of physical activity in young adults: a prospective structural equation analysis. Ann Behav Med. 2002, 24 (2): 149-156. 10.1207/S15324796ABM2402_12.CrossRefPubMed

47.

Marcus BH, Rakowski W, Rossi JS: Assessing motivational readiness and decision making for exercise. Health Psychol. 1992, 11 (4): 257-261.CrossRefPubMed

48.

Marcus BH, Rossi JS, Shelby VC, Niaura RS, Abrams DB: The stages and processes of exercise adoption and maintenance in a worksite sample. Health Psychol. 1992, 11 (6): 386-395.CrossRefPubMed

49.

Jl F: The design and analysis of clinical experiments. 1986, New York: John Wiley & Sons

50.

Collet D: Modeling binary data. 1991, New York: Chapman & HallCrossRef

51.

Rja L: Statistical analysis with missing data. 1987, New York: John Wiley & Sons

52.

David MH, Hornung R, Fichtenbaum CJ: Ischemic cardiovascular disease in persons with human immunodeficiency virus infection. Clin Infect Dis. 2002, 34 (1): 98-102. 10.1086/324745.CrossRefPubMed

53.

Hooshyar D, Hanson DL, Wolfe M, Selik RM, Buskin SE, McNaghten AD: Trends in perimortal conditions and mortality rates among HIV-infected patients. AIDS. 2007, 21 (15): 2093-2100. 10.1097/QAD.0b013e3282e9a664.CrossRefPubMed

54.

Church TS, Barlow CE, Earnest CP, Kampert JB, Priest EL, Blair SN: Associations between cardiorespiratory fitness and C-reactive protein in men. Arterioscler Thromb Vasc Biol. 2002, 22 (11): 1869-1876. 10.1161/01.ATV.0000036611.77940.F8.CrossRefPubMed

55.

Haskell WL: The influence of exercise on the concentrations of triglyceride and cholesterol in human plasma. Exerc Sport Sci Rev. 1984, 12: 205-244.CrossRefPubMed

56.

Ross R, Dagnone D, Jones PJ, Smith H, Paddags A, Hudson R, Janssen I: Reduction in obesity and related comorbid conditions after diet-induced weight loss or exercise-induced weight loss in men. A randomized, controlled trial. Ann Intern Med. 2000, 133 (2): 92-103.CrossRefPubMed

57.

Dolan SE, Frontera W, Librizzi J, Ljungquist K, Juan S, Dorman R, Cole ME, Kanter JR, Grinspoon S: Effects of a supervised home-based aerobic and progressive resistance training regimen in women infected with human immunodeficiency virus: a randomized trial. Arch Intern Med. 2006, 166 (11): 1225-1231. 10.1001/archinte.166.11.1225.CrossRefPubMedPubMedCentral

58.

Fitch KV, Anderson EJ, Hubbard JL, Carpenter SJ, Waddell WR, Caliendo AM, Grinspoon SK: Effects of a lifestyle modification program in HIV-infected patients with the metabolic syndrome. AIDS. 2006, 20 (14): 1843-1850. 10.1097/01.aids.0000244203.95758.db.CrossRefPubMed

The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/13/502/prepub

Title: A home-based exercise intervention to increase physical activity among people living with HIV: study design of a randomized clinical trial
Authors: Jason R Jaggers
Wesley Dudgeon
Steven N Blair
Xuemei Sui
Stephanie Burgess
Sara Wilcox
Gregory A Hand
Publication date: 01-12-2013
Publisher: BioMed Central
Published in: BMC Public Health / Issue 1/2013
Electronic ISSN: 1471-2458
DOI: https://doi.org/10.1186/1471-2458-13-502

ACC 2024 Congress

Springer Medicine

A home-based exercise intervention to increase physical activity among people living with HIV: study design of a randomized clinical trial

Abstract

Background

Methods/design

Discussion

Trial registration

ACC 2024 Congress

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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