Clinical trial NCT02358109: The Flamenco (Fitness League Against MENopause COsts) Project
Official title: Cost-Effectiveness of an Exercise Program in Midlife Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Diabetes
Dyslipidemias
Metabolic Syndrome
Quality of Life
Keywords: Cost-Benefit Analysis, Exercise,Women,Diseases/Prevention
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Andalusian Regional Ministry of Health
First posted: 2015-02-06
Enrollment: 160
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Incremental Cost Effectiveness Ratio (ICER)
timeFrame: 16 weeks
Secondary outcomes:
measure: Quality Adjusted Life Years (QALYs)
timeFrame: 16 weeks
Other outcomes:
measure: Blood pressure
timeFrame: 16 weeks
measure: Resting heart rate
timeFrame: 16 weeks
measure: Body composition
timeFrame: 16 weeks
measure: Lower body muscular strength
timeFrame: 16 weeks
measure: Upper body muscular strength
timeFrame: 16 weeks
measure: Lower body flexibility
timeFrame: 16 weeks
measure: Upper body flexibility
timeFrame: 16 weeks
measure: Motor agility/dynamic balance
timeFrame: 16 weeks
measure: Static balance
timeFrame: 16 weeks
measure: Cardiorespiratory fitness
timeFrame: 16 weeks
measure: Physical activity
timeFrame: 16 weeks
measure: Sedentary behaviour
timeFrame: 16 weeks
measure: Sleep Quality
timeFrame: 16 weeks
measure: Fatigue
timeFrame: 16 weeks
measure: Mediterranean Diet Score (MDS)
timeFrame: 16 weeks
measure: Hemogram profile
timeFrame: 16 weeks
Locations:
city: Granada
country: Spain
facility: Department of Physiology, Faculty of Farmacy, University of Granada
state: Andalucía
Study officials:
affiliation: Universidad de Granada
name: Virginia Aparicio García-Molina, PhD
role: PRINCIPAL_INVESTIGATOR
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