The Flamenco (Fitness League Against MENopause COsts) Project

Diabetes Clinical Trial

— FLAMENCO  

Official title:

Cost-Effectiveness of an Exercise Program in Midlife Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358109
• Other study ID #: FLAMENCO
• Status: Completed
• Phase: N/A
• First received: September 23, 2014
• Last updated: October 24, 2016
• Start date: January 2014
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Spain is the second country in the world that consumes 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.

The present study is a Randomized Controlled Trial (RCT). The study protocols were approved by the Ethics Committee for Research Involving Human Subjects at the University of Granada. All participants have to provide a written informed consent. After baseline measurements, they will be randomly allocated to the usual care (control) or exercise intervention group. The participants will be followed for 16 weeks during the training interventions. All the baseline and follow-up examinations will be performed in the same setting (two primary care health centers) and by the same researchers. The study will follow the ethical guidelines of the Declaration of Helsinki (last modified in 2013).

Participants at the control group will receive general advices about the positive effects of physical activity by pamphlets describing the benefits their benefits and general guidelines about how to increase the daily physical activity levels.

The exercise intervention will be performed in groups of 20 participants. Each group will train 3 days/week (60 min per session) for a 16-week period. It will meet the minimum training standards of the American College of Sports Medicine(Garber, Blissmer et al. 2011). Each exercise session will be designed and supervised by exercise monitors and will include a 15 minute warm-up period followed by 35 minute focused mainly on aerobic exercises, developed progressively and resistance strength training.

Monday sessions will involve resistance strength exercises developed at a slow pace including a stepped progression during the program. Resistance strength training will include 1-3 set of 12-20 repetitions of 8-10 exercises involving all major muscle groups. The strengthening exercises will include biceps curls, arm extensions, arm side lifts, shoulder elevations, lateral leg elevations, stands up from seated position, lunge, sideways lunge and step-up/step-down and similar exercises. The load will be gradually increased as the strength of each person improves. Body weight and barbells will be used at the start of the program. 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. The exercise sessions will finish with a 10 minute cool-down period of stretching and relaxation exercises.

Heart rate will be assessed with a heart rate monitor (Polar Electro OY, Finland) in order to control the intensity of the sessions. One third of the patients in the intervention group will wear heart rate monitors in 1/3 of the sessions, randomly selected. The rate of perceived exertion (RPE) will be monitored using the Borg's conventional (6-20 point) scale(Borg 1982). Intensity (expressed as RPE) will range from 12 to 16-17. To maximize adherence, several strategies will be implemented including music in all sessions, individualized attention at the intervention sessions and telephone calls following missed sessions. Make-up sessions will be allowed in case of missing sessions (due to illness or any other reason).

During the Flamenco Project development X main measurement categories will be assessed: 1) socio-demographic and clinical information; 2) blood pressure and resting heart rate; 3) body composition; 4) physical fitness; 5) physical activity and sedentary behaviour; 6) sleep quality; 7) fatigue; 8) mental health; 9) dietary patterns and 10) hormonal, glycemic and lipid profile.

First, the participants will be cited for the blood analysis. Secondly, they will have to attend to the primary care health center for the socio-demographic and clinical information, blood samples extraction, blood pressure and resting heart rate, body composition and physical fitness assessments. This day, the participant will receive the accelerometer and nine days later she will have to return it in the same primary care health center. During those nine days, the participants will have to complete the questionnaires

1. Socio-demographic and clinical information will be collected using a questionnaire regarding smoking and alcohol habits, history of illness, menopause status and symptoms, indicators of socio-economic status, marital status and number of children. The pharmacology registry will be consulted by the primary health care staff in the medical database.

2. Blood pressure and resting heart rate, systolic and diastolic blood pressure, as well as resting heart rate, will be measured after 5 minutes of rest, two times with 2 minutes apart, with the participant seated. The lowest value will be selected for the analysis.

3. Body Composition: Lean, fat and bone mass of the whole body will be measured. Height (cm) and waist circumference (cm) will be also assessed.

4. Physical fitness will be assessed by means of the following tests:

• Lower body muscular strength: 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(Rikli and Jones 1999).

• Upper body muscular strength: 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) (Ruiz-Ruiz, Mesa et al. 2002).

• Lower body flexibility: It will be used the Sit and Reach test(Rodriguez, Gusi et al. 1998) and an adaptation of it called the "Back Saver Sit and Reach" test

• Upper body flexibility by the "back scratch test", a measure of overall shoulder range of motion(Rikli and Jones 1999).

• Motor agility: timed up and go test(Podsiadlo and Richardson 1991).

• Static balance: It was assessed with the Blind Flamingo test(Rodriguez, Gusi et al. 1998) with eyes closed.

• Cardiorespiratory fitness: The modified Bruce protocol(Bruce, Kusumi et al. 1973; Gulati, Pandey et al. 2003) will be performed to estimate maximal oxygen uptake (VO2max), which will be used as measure of cardiorespiratory fitness in the present study. Additionally, the "6-min walk " test(Rikli and Jones 1999) will be evaluated. This test involves determining the maximum distance (meters) that can be walked in 6 min along a 45.7 m rectangular course.

5. Physical activity and sedentary behaviour will be subjectively and objectively assessed:

• Accelerometry: Participants will be asked to wear a tri-axial accelerometer (ActiGraph GT3X+, Pensacola, Florida, US) for 9 consecutive days, starting the same day the monitor was received. Participants will be instructed on how to wear it.

• The Leisure Time Physical Activity Instrument, the Physical Activity at Homework or Workplace Instrument (Mannerkorpi and Hernelid 2005; Munguia-Izquierdo, Legaz-Arrese et al. 2011), the Spanish version of the Sedentary Behaviour Questionnaire(Rosenberg, Norman et al. 2010; Munguia-Izquierdo, Segura-Jimenez et al. 2013) and the short version of the ALPHA Environmental questionnaire(Spittaels, Foster et al. 2009; Spittaels, Verloigne et al. 2010).

6. Sleep quality will be assessed by the Pittsburgh Sleep Quality Index(Buysse, Reynolds et al. 1989), which assesses sleep quality and disturbances over a l-month time interval.

7. Fatigue will be assessed by The Multidimensional Fatigue Inventory-Spanish(Munguia-Izquierdo, Segura-Jimenez et al. 2012) which is a 20-item assessment tool with five domains: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation.

8. Mental Health will be evaluated by a wide range of tests: Mini Mental State Examination(Folstein, Folstein et al. 1975), the Short-Form Health Survey 36 (SF-36) (Alonso, Prieto et al. 1995), the Spanish version of the Rosenberg Self-Esteem Scale(Vazquez, Jimenez et al. 2004), the Subjective Happiness Scale(Lyubomirsky and Lepper 1999; Extremera and Fernández-Berrocal 2013), the 10-item Connor-Davidson Resilience Scale(Campbell-Sills and Stein 2007; Notario-Pacheco, Solera-Martinez et al. 2011), the brief COPE(Carver 1997; Morán, Landero et al. 2009), the Beck Depression Inventory-II(Beck, Ward et al. 1961; Beck, Steer et al. 2006), the State Trait Anxiety Inventory (Spielberger CD, Gorsuch RL et al. 2002); mood state will be assessed using a Profile of Mood State questionnaireMcNair D.M., Lorr M., Droppleman L.F. Revised Manual for the Profile of Mood States. Educational and Industrial Testing Services; San Diego, CA, USA: 1992.

Positive health will be assessed by means of the following questionnaires: the Trait Meta-Mood Scale(Fernandez-Berrocal, Extremera et al. 2004), the Positive and Negative Affectivity Schedule(Watson, Clark et al. 1988; Sandín, Chorot et al. 1999), the Satisfaction With Life Scale(Diener, Emmons et al. 1985; Atienza, Pons et al. 2000) and the Life Orientation Test Revised(Scheier, Carver et al. 1994; Otero, Luengo et al. 1998) The EuroQol 5D (EQ-5D) will be used to assess five dimensions of health related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each of which is defined through five severity levels(Badia, Roset et al. 1999; Herdman, Badia et al. 2001).

9. Dietary patterns will be evaluated by the Food Frequency Questionnaire and the Mediterranean Diet Score created by Panagiotakos et al. in 2006(Panagiotakos, Pitsavos et al. 2006)

10. Hormonal, glycemic and lipid profile will be assess by the blood sample collection with standard methods using an autoanalyzer.

The analysis in this study will be a cost-utility analysis with a health system perspective. It will be conducted considering the costs and the health effects of the intervention. The measurement of health effects will be the Quality Adjusted Life Years (QALYs).

This study try to determine the effectiveness and cost-effectiveness of a primary health care-based exercise intervention aimed to reduce CVD risk, improve body composition, physical fitness and mental health in middle-aged women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes
• Dyslipidemias
• Metabolic Syndrome
• Metabolic Syndrome X
• Quality of Life

Intervention

Behavioral:
• exercise
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.

Locations

Country	Name	City	State
Spain	Department of Physiology, Faculty of Farmacy, University of Granada	Granada	Andalucía

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Granada	Andalusian Regional Ministry of Health

Country where clinical trial is conducted

Spain, 

References & Publications (38)

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood pressure	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.	16 weeks	Yes
Other	Resting heart rate	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.	16 weeks	Yes
Other	Body composition	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).	16 weeks	Yes
Other	Lower body muscular strength	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	16 weeks	Yes
Other	Upper body muscular strength	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.	16 weeks	Yes
Other	Lower body flexibility	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.	16 weeks	Yes
Other	Upper body flexibility	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.	16 weeks	Yes
Other	Motor agility/dynamic balance	"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.	16 weeks	Yes
Other	Static balance	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.	16 weeks	Yes
Other	Cardiorespiratory fitness	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.	16 weeks	Yes
Other	Physical activity	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.	16 weeks	Yes
Other	Sedentary behaviour	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.	16 weeks	Yes
Other	Sleep Quality	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.	16 weeks	Yes
Other	Fatigue	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.	16 weeks	Yes
Other	Mediterranean Diet Score (MDS)	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.	16 weeks	Yes
Other	Hemogram profile	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).	16 weeks	Yes
Primary	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	Yes
Secondary	Quality Adjusted Life Years (QALYs)	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.	16 weeks	Yes