The Flamenco (Fitness League Against MENopause COsts) Project (FLAMENCO)
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|ClinicalTrials.gov Identifier: NCT02358109|
Recruitment Status : Completed
First Posted : February 6, 2015
Last Update Posted : October 25, 2016
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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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Diabetes Dyslipidemias Metabolic Syndrome Quality of Life||Behavioral: exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Cost-Effectiveness of an Exercise Program in Midlife Women|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||May 2016|
Experimental: Intervention arm
Intervention group receive directed classes of physical conditioning, 3 hours/week during a period of 16 weeks
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.
No Intervention: Control arm
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
- The Incremental Cost Effectiveness Ratio (ICER) [ Time Frame: 16 weeks ]It is calculated dividing the difference between the average costs of both groups by the difference in mean QALYs gained in both groups.
- Quality Adjusted Life Years (QALYs) [ Time Frame: 16 weeks ]This is an average of cost and effectiveness (the mean QALYs gained) in both groups, control and intervention. The QALYs are calculated multiplying the years of life by the patient's quality of life. The Patients' quality of life will be assessed by the EQ-5D questionnaire.
- Blood pressure [ Time Frame: 16 weeks ]Systolic and diastolic blood pressure will be measured after 5 minutes of rest, two times 2 minutes apart, with the person sit down (Omron Health Care Europe B.V. Hoolddorp). The lowest value of two trials will be selected for the analysis.
- Resting heart rate [ Time Frame: 16 weeks ]Resting heart rate will be measured after 5 minutes of rest, two times 2 minutes apart, with the person sit down (Omron Health Care Europe B.V. Hoolddorp). The lowest value of two trials will be selected for the analysis.
- Body composition [ Time Frame: 16 weeks ]Lean, fat and bone mass of the whole body will be measured using dual-energy x-ray absorptiometry (DXA) with a Hologic QDR-4500A device (software version 11.2.1; Hologic, Bedford, MA, USA). Height (cm) will be measured using a stadiometer (Seca 22, Hamburg, Germany). Waist circumference (cm) will be assessed with the participant standing at the middle point between the ribs and the ileac crest (Harpenden anthropometric tape, Holtain Ltd).
- Lower body muscular strength [ Time Frame: 16 weeks ]The "30-s chair stand" test involves counting the number of times within 30 s that an individual can rise to a full stand from a seated position with back straight and feet flat on the floor, without pushing off with the arms. The patients will perform one trial after familiarization
- Upper body muscular strength [ Time Frame: 16 weeks ]The "Arm curl" test involves determining a number of times a hand weight (2.3 kg for women) can be curled through a full range of motion in 30 s. Additionally, handgrip strength will be measured using a digital dynamometer (TKK 5101 Grip-D;Takey, Tokyo, Japan) as described elsewhere. Patients will perform (alternately with both hands) the test twice allowing a 1-min rest period between measures. The best value of 2 trials for each hand will be chosen and the average of both hands will be used in the analyses.
- Lower body flexibility [ Time Frame: 16 weeks ]The "Sit and Reach" test in which participant will be required to sit with knees straight and legs together, and feet placed against the box. The participant slowly reached forward as far as possible. The final position that the participant reached in centimeters will be the score for the test. The best score of two attempts will be recorded.
- Upper body flexibility [ Time Frame: 16 weeks ]The "back scratch" test, a measure of overall shoulder range of motion, involves measuring the distance between (or overlap of) the middle fingers behind the back with a ruler. Participants will perform this test twice, alternately with both hands, and the best value will be registered. The average of both hands will be used in the analyses.
- Motor agility/dynamic balance [ Time Frame: 16 weeks ]"Timed up and go test",with the participant sit in a chair (seat height 44 cm, depth 45 cm, width 49 cm, armrest height 64 cm) with arms and trunk supported. Subjects will be instructed to stand up on the word "go" and walk three meters in a straight line, turned 180 degrees, walk back to the chair and sit down again in the chair. Each subject will perform 1 trial to become familiar with the test. After a 1-minute rest, the test will be performed twice separated by a 1-minute rest. The time from the start until the subject sit down in the chair with back support will be measured and the better of the 2 attempts will be used in the data analysis.
- Static balance [ Time Frame: 16 weeks ]It will be assessed through the blind flamingo test with closed eyes. In this test, the number of trials needed to complete 30 s of the static position is recorded, and the chronometer is stopped whenever the patient does not comply with the protocol conditions. One trial will be accomplished for each leg and the average of both values will be selected for the analysis.
- Cardiorespiratory fitness [ Time Frame: 16 weeks ]The modified Bruce protocol will be used as measure of cardiorespiratory fitness The test consists of 5 increasing workload stages of 3 minutes each (stage 1: 1.7mph and 10% inclination; stage 2: 2.5mph and 12% inclination; stage 3: 3.4mph and 14% inclination; stage 4: 4.2mph and 16% inclination; stage 5: 5mph and 18% inclination). The test will terminate when the 85% of the individual's heart rate reserve (HRR) will be accomplished. VO2max will be estimated with the formula by Bruce et al.: VO2max= 6.70 - 2.82*2 + 0.056*duration of the test. Additionally, we will also assess the "6-minutes walk" test. This test involves determining the maximum distance (meters) that can be walked in 6 minutes along a 45.7 m rectangular course.
- Physical activity [ Time Frame: 16 weeks ]It will be used a tri-axial accelerometer (ActiGraph GT3X+, Pensacola, Florida, US) for 8 consecutive days. Monitor wearing time will be calculated by subtracting the non-wear time and the sleeping time (recorded through a diary) from the total registered time for the entire day. A total of 7 days of recording with a minimum of ten or more hours of registration per day will be necessary to be included in the study. Physical activity levels will expressed as mean counts per minute. This is a measure of overall physical activity. We will calculate mean counts per minute by dividing the sum of total counts per epoch for a valid day by the number of minutes of wear time in that day across all valid days. We will also calculate the time engaged in light, lifestyle, moderate, and moderate and vigorous intensity physical activity based upon a standardized cut-offs.
- Sedentary behaviour [ Time Frame: 16 weeks ]It will be used a tri-axial accelerometer (ActiGraph GT3X+, Pensacola, Florida, US) for 8 consecutive days. Monitor wearing time will be calculated by subtracting the non-wear time and the sleeping time (recorded through a diary) from the total registered time for the entire day. A total of 7 days of recording with a minimum of ten or more hours of registration per day will be necessary to be included in the study. Sedentary time will be calculated as the amount of time accumulated below 100 counts per minute during periods of wear time.
- Sleep Quality [ Time Frame: 16 weeks ]The Pittsburgh Sleep Quality Index will be used to assess sleep quality and disturbances over a l-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score.
- Fatigue [ Time Frame: 16 weeks ]The Multidimensional Fatigue Inventory-Spanish is a 20-item assessment tool with five domains: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Activity, and Reduced Motivation. Each domain consists of four items and has a potential score range from 4 to 20, where higher scores indicate a high degree of fatigue.
- Mediterranean Diet Score (MDS) [ Time Frame: 16 weeks ]It evaluates the degree of adherence to the traditional Mediterranean dietary pattern. It consists on 11 items and scores ranging from 0-5 based on frequency of consumption (servings/month: Never, 1-4, 5-8, 9-12, 13-18, >18). Seven of them scores positively with increased consumption, as they are components of the Mediterranean Diet (non-refined cereals, potatoes, fruits, vegetables, legumes, fish, and olive oil). The score of the item "use of olive oil" in cooking ranges from never (0) to daily (5) (times/week). Red meat and derivates, poultry and full fat dairy products score positively with less consumption. Especially for alcohol, the score 5 is assigned for consumption of less than 300 ml/day, score 0 for consumption of more than 700 ml/day or none and scores 1-4 for consumption of 300-400, 400-500, 500-600, and 600-700 ml/day, respectively. Thus, the total score assigned ranges from 0-55, with higher scores indicating greater adhesion to the Mediterranean diet pattern.
- Hemogram profile [ Time Frame: 16 weeks ]Venous blood samples will be taken in vacuum tubes in standardized fasting conditions at 8-9 am in the primary care health center and transported to the laboratory for their posterior analysis. Two vacuum tubes will be collected for each participant and one of them will contain EDTA/K3 to determine blood cells count, blood hemoglobin concentration and hematocrit. Plasma total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, glucose, insulin, albumin, total proteins, creatinine, uric acid, creatine kinase, sodium, potassium, glycosylated hemoglobin and thyroid-stimulating hormone levels will be assessed with standard methods using an autoanalyzer (Hitachi-Roche p800, F. Hoffmann-La Roche Ltd. Switzerland).
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|Ages Eligible for Study:||45 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358109
|Department of Physiology, Faculty of Farmacy, University of Granada|
|Granada, Andalucía, Spain, 18071|
|Principal Investigator:||Virginia Aparicio García-Molina, PhD||Universidad de Granada|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Virginia A. Aparicio García-Molina, PhD Sport Sciences, PhD Nutrition and Food Technology, Universidad de Granada|
|Other Study ID Numbers:||
|First Posted:||February 6, 2015 Key Record Dates|
|Last Update Posted:||October 25, 2016|
|Last Verified:||October 2016|
Cost-Benefit Analysis, Exercise,Women,Diseases/Prevention
Glucose Metabolism Disorders
Lipid Metabolism Disorders