The Flamenco (Fitness League Against MENopause COsts) Project

NCT02358109 | Completed DMC

• 1 other identifier: FLAMENCO
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Spain is the second country in the world that consume more drugs. The average drug expenditure per capita in Andalucía during 2011 was 219.2 €. This drug spending increases during the perimenopausal period. According to the Study of the Economic Impact of Sport on Health Spending of the Ministry of Health of the Generalitat of Catalonia, for every euro invested in sports promotion 50 euros are saved in health spending accumulated over 15 years. The main objectives of this project are: i) To analyze the (cost-effectiveness) effect of an exercise program on the prescription of drugs in a sample of Andalusian women aged 45-60 years. ii ) To study the level of physical activity and sedentarism (measured objectively by accelerometry ) , functional capacity , quality of life and clinical profile of this population. iii ) To analyze the relationship between levels of physical activity / sedentarism and pharmaceutical expenditure. In the present project, an exercise program aimed at minimizing symptoms and health problems associated with the perimenopausal period will be performed (Dyslipidemia, diabetes, anxiety, depression, quality of life, quality of sleep, obesity, osteoporosis and cardiovascular disease). A total of 160 perimenopausal women will be randomly assigned to the intervention group exercise (n = 80 ) or to the usual care group (n = 80). Participants in the intervention group will train 3 days / week ( 60 min per session ) for 16 weeks. With the analysis of the results of this project new patterns of objective work as well as the most significant practical resources for the design of a master plan may be determined. Results are expected to be able to shed some light on the implementation of programs of health promotion that are both time beneficial for the Andalusian Public Health and for the family , institutional and community economy.

Conditions

Cardiovascular Diseases; Diabetes; Dyslipidemias; Metabolic Syndrome; Quality of Life

Keywords

Cost-Benefit Analysis, Exercise,Women,Diseases/Prevention

Outcome Measures

Primary Outcomes (1)

• The Incremental Cost Effectiveness Ratio (ICER)

  It is calculated dividing the difference between the average costs of both groups by the difference in mean QALYs gained in both groups.

  16 weeks

Secondary Outcomes (1)

• Quality Adjusted Life Years (QALYs)

  16 weeks

Other Outcomes (16)

• Blood pressure

  16 weeks

• Resting heart rate

  16 weeks

• Body composition

  16 weeks

Study Arms (2)

Intervention arm

EXPERIMENTAL

Intervention group receive directed classes of physical conditioning, 3 hours/week during a period of 16 weeks

Behavioral: exercise

Control arm

NO INTERVENTION

Control group do not receive physical conditioning intervention but usual care advice and are measured at the beginning and at the end of the study

Interventions

exercise BEHAVIORAL

The exercise intervention will be performed in groups of 20 participants which will train 3 days/week (60 min per session) for a 16-week period. Sessions will be designed and carefully supervised by exercise monitors, including a 15 minute warm-up period followed by 35 minute focused on aerobic exercises, developed progressively at intensity sufficient to achieve 50% (at the beginning of the intervention) and 80% (the last month of the intervention) of predicted maximum heart rate (209-0.73 × age) and resistance strength training.Monday sessions will involve resistance strength exercises. Wednesday sessions will include balance oriented activities and dancing aerobic exercises. Fridays will include aerobic, resistance strength and coordination using a circuit of different exercises.Sessions finish with a 10 minute cool-down period of stretching and relaxation exercises.

Intervention arm

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 45-60 years.
• Not to have other severe somatic or psychiatric disorders, or other diseases that prevent physical loading (Answer "no" to all questions on the Physical Activity Readiness Questionnaire-PAR-Q) .
• Not to be engaged in regular physical activity \>20 min on \>3 days/week.
• Able to ambulate, with or without assistance.
• Able to communicate.
• Informed consent: Must be capable and willing to provide consent.

You may not qualify if:

• Acute or terminal illness.
• Myocardial infarction in the past 3 months.
• Not capable to ambulate.
• Unstable cardiovascular disease or other medical condition.
• Upper or lower extremity fracture in the past 3 months.
• Severe dementia (MMSE \< 10).
• Unwillingness to either complete the study requirements or to be randomised into control or training group.
• Presence of neuromuscular disease or drugs affecting neuromuscular function.

Sponsors & Collaborators

• Universidad de Granada: lead
• Andalusian Regional Ministry of Health: collaborator

Study Sites (1)

Department of Physiology, Faculty of Farmacy, University of Granada

Granada, Andalusia, 18071, Spain

Location

Related Publications (44)

• Gulati M, Pandey DK, Arnsdorf MF, Lauderdale DS, Thisted RA, Wicklund RH, Al-Hani AJ, Black HR. Exercise capacity and the risk of death in women: the St James Women Take Heart Project. Circulation. 2003 Sep 30;108(13):1554-9. doi: 10.1161/01.CIR.0000091080.57509.E9. Epub 2003 Sep 15.

  PMID: 12975254 BACKGROUND

• Mannerkorpi K, Hernelid C. Leisure Time Physical Activity Instrument and Physical Activity at Home and Work Instrument. Development, face validity, construct validity and test-retest reliability for subjects with fibromyalgia. Disabil Rehabil. 2005 Jun 17;27(12):695-701. doi: 10.1080/09638280400009063.

  PMID: 16012062 BACKGROUND

• Otero, J. M., A. Luengo, et al. (1998). Psicología de la Personalidad. Manual de prácticas. Barcelona, Ariel Practicum.

  BACKGROUND

• Sandín, B., P. Chorot, et al. (1999).

  BACKGROUND

• Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test. J Pers Soc Psychol. 1994 Dec;67(6):1063-78. doi: 10.1037//0022-3514.67.6.1063.

  PMID: 7815302 BACKGROUND

• Extremera, N. and P. Fernández-Berrocal (2013).

  BACKGROUND

• Alonso J, Prieto L, Anto JM. [The Spanish version of the SF-36 Health Survey (the SF-36 health questionnaire): an instrument for measuring clinical results]. Med Clin (Barc). 1995 May 27;104(20):771-6. Spanish.

  PMID: 7783470 RESULT

• Pons D, Atienza FL, Balaguer I, Garcia-Merita ML. Satisfaction with life scale: analysis of factorial invariance for adolescents and elderly persons. Percept Mot Skills. 2000 Aug;91(1):62-8. doi: 10.2466/pms.2000.91.1.62.

  PMID: 11011872 RESULT

• Badia X, Roset M, Montserrat S, Herdman M, Segura A. [The Spanish version of EuroQol: a description and its applications. European Quality of Life scale]. Med Clin (Barc). 1999;112 Suppl 1:79-85. Spanish.

  PMID: 10618804 RESULT

• BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.

  PMID: 13688369 RESULT

• Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

  PMID: 7154893 RESULT

• Bruce RA, Kusumi F, Hosmer D. Maximal oxygen intake and nomographic assessment of functional aerobic impairment in cardiovascular disease. Am Heart J. 1973 Apr;85(4):546-62. doi: 10.1016/0002-8703(73)90502-4. No abstract available.

  PMID: 4632004 RESULT

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 RESULT

• Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-davidson Resilience Scale (CD-RISC): Validation of a 10-item measure of resilience. J Trauma Stress. 2007 Dec;20(6):1019-28. doi: 10.1002/jts.20271.

  PMID: 18157881 RESULT

• Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.

  PMID: 16250744 RESULT

• Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.

  PMID: 16367493 RESULT

• Fernandez-Berrocal P, Extremera N, Ramos N. Validity and reliability of the Spanish modified version of the Trait Meta-Mood Scale. Psychol Rep. 2004 Jun;94(3 Pt 1):751-5. doi: 10.2466/pr0.94.3.751-755.

  PMID: 15217021 RESULT

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 RESULT

• Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.

  PMID: 21694556 RESULT

• Herdman M, Badia X, Berra S. [EuroQol-5D: a simple alternative for measuring health-related quality of life in primary care]. Aten Primaria. 2001 Oct 15;28(6):425-30. doi: 10.1016/s0212-6567(01)70406-4. No abstract available. Spanish.

  PMID: 11602124 RESULT

• Lyubomirsky, S. and H. S. Lepper (1999).

  RESULT

• Morán, C., R. Landero, et al. (2009).

  RESULT

• Munguia-Izquierdo D, Legaz-Arrese A, Mannerkorpi K. Transcultural adaptation and psychometric properties of a Spanish-language version of physical activity instruments for patients with fibromyalgia. Arch Phys Med Rehabil. 2011 Feb;92(2):284-94. doi: 10.1016/j.apmr.2010.10.019.

  PMID: 21272726 RESULT

• Munguia-Izquierdo D, Segura-Jimenez V, Camiletti-Moiron D, Alvarez-Gallardo IC, Estevez-Lopez F, Romero A, Chillon P, Carbonell-Baeza A, Ortega FB, Ruiz JR, Delgado-Fernandez M. Spanish adaptation and psychometric properties of the Sedentary Behaviour Questionnaire for fibromyalgia patients: the al-Andalus study. Clin Exp Rheumatol. 2013 Nov-Dec;31(6 Suppl 79):S22-33. Epub 2013 May 27.

  PMID: 23710552 RESULT

• Munguia-Izquierdo D, Segura-Jimenez V, Camiletti-Moiron D, Pulido-Martos M, Alvarez-Gallardo IC, Romero A, Aparicio VA, Carbonell-Baeza A, Delgado-Fernandez M. Multidimensional Fatigue Inventory: Spanish adaptation and psychometric properties for fibromyalgia patients. The Al-Andalus study. Clin Exp Rheumatol. 2012 Nov-Dec;30(6 Suppl 74):94-102. Epub 2012 Dec 14.

  PMID: 23261007 RESULT

• Notario-Pacheco B, Solera-Martinez M, Serrano-Parra MD, Bartolome-Gutierrez R, Garcia-Campayo J, Martinez-Vizcaino V. Reliability and validity of the Spanish version of the 10-item Connor-Davidson Resilience Scale (10-item CD-RISC) in young adults. Health Qual Life Outcomes. 2011 Aug 5;9:63. doi: 10.1186/1477-7525-9-63.

  PMID: 21819555 RESULT

• Panagiotakos DB, Pitsavos C, Stefanadis C. Dietary patterns: a Mediterranean diet score and its relation to clinical and biological markers of cardiovascular disease risk. Nutr Metab Cardiovasc Dis. 2006 Dec;16(8):559-68. doi: 10.1016/j.numecd.2005.08.006. Epub 2006 Feb 9.

  PMID: 17126772 RESULT

• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 RESULT

• Rikli RE, Jones CJ. Development and validation of criterion-referenced clinically relevant fitness standards for maintaining physical independence in later years. Gerontologist. 2013 Apr;53(2):255-67. doi: 10.1093/geront/gns071. Epub 2012 May 20.

  PMID: 22613940 RESULT

• Rodriguez, F. A., N. Gusi, et al. (1998).

  RESULT

• Rosenberg DE, Norman GJ, Wagner N, Patrick K, Calfas KJ, Sallis JF. Reliability and validity of the Sedentary Behavior Questionnaire (SBQ) for adults. J Phys Act Health. 2010 Nov;7(6):697-705. doi: 10.1123/jpah.7.6.697.

  PMID: 21088299 RESULT

• Ruiz-Ruiz J, Mesa JL, Gutierrez A, Castillo MJ. Hand size influences optimal grip span in women but not in men. J Hand Surg Am. 2002 Sep;27(5):897-901. doi: 10.1053/jhsu.2002.34315.

  PMID: 12239682 RESULT

• Spielberger CD, Gorsuch RL, et al., Eds. (2002). STAI: Manual del Cuestionario de Ansiedad Estado-Rasgo. Madrid, TEA Ediciones.

  RESULT

• Spittaels H, Foster C, Oppert JM, Rutter H, Oja P, Sjostrom M, De Bourdeaudhuij I. Assessment of environmental correlates of physical activity: development of a European questionnaire. Int J Behav Nutr Phys Act. 2009 Jul 6;6:39. doi: 10.1186/1479-5868-6-39.

  PMID: 19580645 RESULT

• Spittaels H, Verloigne M, Gidlow C, Gloanec J, Titze S, Foster C, Oppert JM, Rutter H, Oja P, Sjostrom M, De Bourdeaudhuij I. Measuring physical activity-related environmental factors: reliability and predictive validity of the European environmental questionnaire ALPHA. Int J Behav Nutr Phys Act. 2010 May 26;7(1):48. doi: 10.1186/1479-5868-7-48.

  PMID: 20504339 RESULT

• Vazquez, A. J., R. Jimenez, et al. (2004).

  RESULT

• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

  PMID: 3397865 RESULT

• Beck, A. T., R. A. Steer, et al. (2006). BDI-II. Inventario de Depresión de Beck. Buenos Aires, Editorial Paidos.

  RESULT

• Marin-Jimenez N, Flor-Alemany M, Ruiz-Montero PJ, Coll-Risco I, Aparicio VA. Effects of concurrent exercise on health-related quality of life in middle-aged women. Climacteric. 2023 Apr;26(2):88-94. doi: 10.1080/13697137.2022.2153032. Epub 2022 Dec 15.

  PMID: 36519287 DERIVED

• Coll-Risco I, de la Flor Alemany M, Acosta-Manzano P, Borges-Cosic M, Camiletti-Moiron D, Baena-Garcia L, Aparicio VA. The influence of an exercise program in middle-aged women on dietary habits. The FLAMENCO project. Menopause. 2022 Dec 1;29(12):1416-1422. doi: 10.1097/GME.0000000000002071. Epub 2022 Sep 20.

  PMID: 36126236 DERIVED

• Aparicio VA, Flor-Alemany M, Marin-Jimenez N, Coll-Risco I, Aranda P. A 16-week concurrent exercise program improves emotional well-being and emotional distress in middle-aged women: the FLAMENCO project randomized controlled trial. Menopause. 2021 Mar 11;28(7):764-771. doi: 10.1097/GME.0000000000001760.

  PMID: 33739319 DERIVED

• Marin-Jimenez N, Ruiz-Montero PJ, De la Flor-Alemany M, Aranda P, Aparicio VA. Association of objectively measured sedentary behavior and physical activity levels with health-related quality of life in middle-aged women: The FLAMENCO project. Menopause. 2020 Apr;27(4):437-443. doi: 10.1097/GME.0000000000001494.

  PMID: 32068685 DERIVED

• Aparicio VA, Marin-Jimenez N, Coll-Risco I, de la Flor-Alemany M, Baena-Garcia L, Acosta-Manzano P, Aranda P. Doctor, ask your perimenopausal patient about her physical fitness; association of self-reported physical fitness with cardiometabolic and mental health in perimenopausal women: the FLAMENCO project. Menopause. 2019 Oct;26(10):1146-1153. doi: 10.1097/GME.0000000000001384.

  PMID: 31513090 DERIVED

• Carbonell-Baeza A, Soriano-Maldonado A, Gallo FJ, Lopez del Amo MP, Ruiz-Cabello P, Andrade A, Borges-Cosic M, Peces-Rama AR, Spacirova Z, Alvarez-Gallardo IC, Garcia-Mochon L, Segura-Jimenez V, Estevez-Lopez F, Camiletti-Moiron D, Martin-Martin JJ, Aranda P, Delgado-Fernandez M, Aparicio VA. Cost-effectiveness of an exercise intervention program in perimenopausal women: the Fitness League Against MENopause COst (FLAMENCO) randomized controlled trial. BMC Public Health. 2015 Jun 17;15:555. doi: 10.1186/s12889-015-1868-1.

  PMID: 26081934 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Dyslipidemias; Metabolic Syndrome; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Virginia Aparicio García-Molina, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Sport Sciences, PhD Nutrition and Food Technology

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: February 6, 2015
• Study Start: January 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: May 1, 2016
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

ES (1)