Skip to main content
Clinical Trials/NCT02358109
NCT02358109CompletedNot Applicable

Cost-Effectiveness of an Exercise Program in Midlife Women

Universidad de Granada1 site in 1 country160 target enrollmentStarted: January 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
160
Locations
1
Primary Endpoint
The Incremental Cost Effectiveness Ratio (ICER)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
45 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Intervention arm

Experimental

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

Intervention: exercise (Behavioral)

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Quality Adjusted Life Years (QALYs)(16 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Virginia A. Aparicio García-Molina

PhD Sport Sciences, PhD Nutrition and Food Technology

Universidad de Granada

Study Sites (1)

Loading locations...

Similar Trials