Effect of including fitness testing in preventive health checks on cardiorespiratory fitness and motivation: study protocol of a randomized controlled trial

Kirsten Høj, Mette Vinther Skriver, Anne-Louise Smidt Hansen, Bo Christensen, Helle Terkildsen Maindal, Annelli Sandbæk, Kirsten Høj, Mette Vinther Skriver, Anne-Louise Smidt Hansen, Bo Christensen, Helle Terkildsen Maindal, Annelli Sandbæk

Abstract

Background: Preventive health checks may identify individuals with an unhealthy lifestyle and motivate them to change behaviour. However, knowledge about the impact of the different components included in preventive health checks is deficient. The aim of this trial is to evaluate whether including cardiorespiratory fitness testing in preventive health checks 1) increases cardiorespiratory fitness level and motivation to change physical activity behaviour and 2) reduces physical inactivity prevalence and improves self-rated health compared with preventive health checks without fitness testing.

Methods/design: An open-label, household-cluster, randomized controlled trial with a two-group parallel design is used. The trial is embedded in a population-based health promotion program, "Check your Health Preventive Program", in which all 30-49 year-old citizens in a Danish municipality are offered a preventive health check. In each arm of the trial, 750 citizens will be recruited (1,500 in total). The primary outcome is cardiorespiratory fitness level assessed by submaximal cycle ergometer testing after one year. An intermediate outcome is the percentage of participants increasing motivation for physical activity behaviour change between baseline and two-weeks follow-up assessed using the Transtheoretical Model's stages of change. Secondary outcomes include changes from baseline to one-year follow-up in physical inactivity prevalence measured by a modified version of the questions developed by Saltin and Grimby, and in self-rated health measures using the Short-Form 12, Health Survey, version 2.

Discussion: This trial will contribute to a critical appraisal of the value of fitness testing as part of preventive health checks. The conduction in real-life community and general practice structures makes the trial findings applicable and transferable to other municipalities providing support to decision-makers in the development of approaches to increase levels of physical activity and improve health.

Trial registration: ClinicalTrials.gov Identifier: NCT02224248. Registered 8 August 2014.

Figures

Figure 1
Figure 1
Flow of participants in the CHPP and the present trial. R1: Randomization by household to one of the five years in the CHPP. R2: Randomization by household to intervention or control in the present trial prior to dispatching the invitations. Invitation and inclusion proceed continuously until 750 participants in each arm of the trial have received a health check and consented for data to be used scientifically. Abbreviations: CHPP: Check your Health Preventive Program.

References

    1. The World Health Organization: Global action plan for the prevention and control of noncommunicable diseases 2013–2020. []
    1. Dishman R, Ickes W, Morgan W. Self-motivation and adherence to habitual physical-activity. J Appl Soc Psychol. 1980;10(2):115–132. doi: 10.1111/j.1559-1816.1980.tb00697.x.
    1. Dalton AR, Soljak M. The nationwide systematic prevention of cardiovascular disease: the UK's health check programme. J Ambul Care Manage. 2012;35(3):206–215. doi: 10.1097/JAC.0b013e318240be9d.
    1. Check your health preventive program []
    1. Sox HC. The health checkup was it ever effective? Could it be effective? J Am Med Assoc. 2013;309(23):2496–2497. doi: 10.1001/jama.2013.5040.
    1. Maindal HT, Stovring H, Sandbaek A. Effectiveness of the population-based Check your health preventive programme conducted in primary care with 4 years follow-up [the CORE trial]: study protocol for a randomised controlled trial. Trials. 2014;15(1):341. doi: 10.1186/1745-6215-15-341.
    1. Lauritzen T, Jensen MS, Thomsen JL, Christensen B, Engberg M. Health tests and health consultations reduced cardiovascular risk without psychological strain, increased healthcare utilization or increased costs. An overview of the results from a 5-year randomized trial in primary care. The Ebeltoft Health Promotion Project (EHPP) Scand J Public Health. 2008;36(1403–4948; 6):650–661. doi: 10.1177/1403494807090165.
    1. Theobald H, Bygren LO, Carstensen J, Hauffman M, Engfeldt P. Effects of an assessment of needs for medical and social services on long-term mortality: a randomized controlled study. Int J Epidemiol. 1998;27(0300–5771; 2):194–198. doi: 10.1093/ije/27.2.194.
    1. Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: the evidence. CMAJ. 2006;174(1488–2329; 0820–3946; 6):801–809. doi: 10.1503/cmaj.051351.
    1. Lee DC, Artero EG, Sui X, Blair SN. Mortality trends in the general population: the importance of cardiorespiratory fitness. J Psychopharmacol. 2010;24(1461–7285; 0269–8811; 4):27–35. doi: 10.1177/1359786810382057.
    1. French DP, Sutton S. Reactivity of measurement in health psychology: How much of a problem is it? What can be done about it? Br J Health Psychol. 2010;15:453–468. doi: 10.1348/135910710X492341.
    1. McCambridge J, Kypri K, Elbourne D. In randomization we trust? There are overlooked problems in experimenting with people in behavioral intervention trials. J Clin Epidemiol. 2014;67(3):247–253. doi: 10.1016/j.jclinepi.2013.09.004.
    1. Van Sluijs EM, Van Poppel MN, Twisk JW, Van Mechelen W. Physical activity measurements affected participants' behavior in a randomized controlled trial. J Clin Epidemiol. 2006;59(4):404–411. doi: 10.1016/j.jclinepi.2005.08.016.
    1. Spence JC, Burgess J, Rodgers W, Murray T. Effect of pretesting on intentions and behaviour: a pedometer and walking intervention. Psychol Health. 2009;24(7):777–789. doi: 10.1080/08870440801989938.
    1. Ottesen LS, Vang IK, Skjerk O. Kvantitative Del. 2005. En undersøgelse af de inaktive danskere.
    1. Saltin B, Grimby G. Physiological analysis of middle-aged and old former athletes. Comparison with still active athletes of the same ages. Circulation. 1968;38(6):1104–1115. doi: 10.1161/01.CIR.38.6.1104.
    1. Nigg CR. There is more to stages of exercise than just exercise. Exerc Sport Sci Rev. 2005;33(0091–6331; 1):32–35.
    1. Ware JE, Kosinski M, Turner-Bowker DM, Gandeck B. User∩s Manual for the SF-12v2TM Health Survey (With a Supplement Documenting the SF-12 Health Survey) Lincoln, RI: QualityMetric Incorporated; 2007. p. 2007.
    1. Christensen A, Davidsen M, Ekholm O, Hansen SE, Holst M, Juel K. Den nationale sundhedsprofil 2010: - Hvordan har du det? 2010.
    1. Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the alcohol use disorders identification test (AUDIT): who collaborative project on early detection of persons with harmful alcohol consumption–II. Addiction. 1993;88(6):791–804. doi: 10.1111/j.1360-0443.1993.tb02093.x.
    1. Astrand I. Aerobic work capacity in men and women with special reference to age. Acta Physiol Scand Suppl. 1960;49(169):1–92.
    1. Astrand PO, Rodahl K. Textbook of Work Physiology: Physiological Bases of Exercise. 4. Champaign, IL: Human Kinetics; 2003.
    1. Pescatello LS. ACSM´s Guidelines for Exercise Testing and Prescription. 9. Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins; 2014.
    1. Nigg CR, Geller KS, Motl RW, Horwath CC, Wertin KK, Dishman RK. A research agenda to examine the efficacy and relevance of the transtheoretical model for physical activity behavior. Psychol Sport Exerc. 2011;12(1469–0292; 1):7–12. doi: 10.1016/j.psychsport.2010.04.004.
    1. Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998;51(0895–4356; 11):1171–1178. doi: 10.1016/S0895-4356(98)00109-7.
    1. Waters L, Reeves M, Fjeldsoe B, Eakin E. Control group improvements in physical activity intervention trials and possible explanatory factors: a systematic review. J Phys Act Health. 2012;9(6):884–895.
    1. Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004;57(8):785–794. doi: 10.1016/j.jclinepi.2003.12.013.
    1. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340(1756–1833; 0959–535):c869. doi: 10.1136/bmj.c869.
    1. Sterne JA, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, Wood AM, Carpenter JR. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009;338(1756–1833; 0959–535):b2393. doi: 10.1136/bmj.b2393.
    1. Krogsboll LT, Jorgensen KJ, Gronhoj LC, Gotzsche PC. General health checks in adults for reducing morbidity and mortality from disease. Cochrane Database Syst Rev. 2012;10(1469–493; 1361–6137):CD009009.
    1. Kodama S, Saito K, Tanaka S, Maki M, Yachi Y, Asumi M, Sugawara A, Totsuka K, Shimano H, Ohashi Y, Yamada N, Sone H. Cardiorespiratory fitness as a quantitative predictor of all-cause mortality and cardiovascular events in healthy men and women: a meta-analysis. JAMA. 2009;301(1538–3598; 0098–7484; 19):2024–2035. doi: 10.1001/jama.2009.681.
    1. Lee DC, Sui X, Artero EG, Lee IM, Church TS, McAuley PA, Stanford FC, Kohl HW, III, Blair SN. Long-term effects of changes in cardiorespiratory fitness and body mass index on all-cause and cardiovascular disease mortality in men: the Aerobics Center Longitudinal Study. Circulation. 2011;124(1524–4539; 0009–7322; 23):2483–2490. doi: 10.1161/CIRCULATIONAHA.111.038422.
    1. Lee DC, Sui X, Church TS, Lavie CJ, Jackson AS, Blair SN. Changes in fitness and fatness on the development of cardiovascular disease risk factors hypertension, metabolic syndrome, and hypercholesterolemia. J Am Coll Cardiol. 2012;59(1558–3597; 0735–1097; 7):665–672. doi: 10.1016/j.jacc.2011.11.013.
    1. Williams PT. Physical fitness and activity as separate heart disease risk factors: a meta-analysis. Med Sci Sports Exerc. 2001;33(0195–9131; 5):754–761. doi: 10.1097/00005768-200105000-00012.
    1. Rhodes RE, Dickau L. Moderators of the intention-behaviour relationship in the physical activity domain: a systematic review. Br J Sports Med. 2013;47(4):215–225. doi: 10.1136/bjsports-2011-090411.
    1. Amireault S, Godin G, Vezina-Im L. Determinants of physical activity maintenance: a systematic review and meta-analyses. Health Psychol Rev. 2013;7(1):55–91. doi: 10.1080/17437199.2012.701060.
    1. Schumann A, Estabrooks PA, Nigg CR, Hill J. Validation of the stages of change with mild, moderate, and strenuous physical activity behavior, intentions, and self-efficacy. Int J Sports Med. 2003;24(0172–4622; 5):363–365.
    1. Church TS, Earnest CP, Skinner JS, Blair SN. Effects of different doses of physical activity on cardiorespiratory fitness among sedentary, overweight or obese postmenopausal women with elevated blood pressure: a randomized controlled trial. JAMA. 2007;297(1538–3598; 0098–7484; 19):2081–2091. doi: 10.1001/jama.297.19.2081.
    1. Ekblom-Bak E, Hellenius ML, Ekblom O, Engstrom LM, Ekblom B. Independent associations of physical activity and cardiovascular fitness with cardiovascular risk in adults. Eur J Cardiovasc Prev Rehabil. 2010;17(1741–8275; 1741–8267; 2):175–180. doi: 10.1097/HJR.0b013e32833254f2.
    1. Lollgen H. [Importance and evidence of regular physical activity for prevention and treatment of diseases] Dtsch Med Wochenschr. 2013;138(1439–4413; 0012–0472; 44):2253–2259.
    1. Jylha M. What is self-rated health and why does it predict mortality? Towards a unified conceptual model. Soc Sci Med. 2009;69(1873–5347; 0277–9536; 3):307–316. doi: 10.1016/j.socscimed.2009.05.013.
    1. Fleishman JA, Selim AJ, Kazis LE. Deriving SF-12v2 physical and mental health summary scores: a comparison of different scoring algorithms. Qual Life Res. 2010;19(1573–2649; 0962–9343; 2):231–241. doi: 10.1007/s11136-009-9582-z.
    1. Noonan V, Dean E. Submaximal exercise testing: clinical application and interpretation. Phys Ther. 2000;80(8):782–807.
    1. Ekblom B, Engstrom LM, Ekblom O. Secular trends of physical fitness in Swedish adults. Scand J Med Sci Sports. 2007;17(0905–7188; 3):267–273.
    1. Alshurafa M, Briel M, Akl EA, Haines T, Moayyedi P, Gentles SJ, Rios L, Tran C, Bhatnagar N, Lamontagne F, Walter SD, Guyatt GH. Inconsistent definitions for intention-to-treat in relation to missing outcome data: systematic review of the methods literature. PLoS One. 2012;7(1932–6203; 1932–6203; 11):e49163. doi: 10.1371/journal.pone.0049163.
Pre-publication history
    1. The pre-publication history for this paper can be accessed here:

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever