Effectiveness of an Intensive Intervention to Improve Physical Activity in Postmenopausal and Sedentary Women

Study Overview
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Brief Summary
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This is a randomized clinical trial aimed at postmenopausal women aged 45 to 70 years old selected in urban primary care centers of two centers (Spain). Its objective is to evaluate the effects of an intensive intervention in the increase of physical activity and the decrease of sedentary lifestyle in postmenopausal and sedentary women.

Detailed Description
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Objective: to evaluate the effects at 6 months of an intensive intervention in the increase of physical activity and the decrease of sedentary lifestyle in postmenopausal and sedentary women. Design and setting: A randomized clinical trial of two parallel groups. Population: 100 postmenopausal women, 45 to 70 aged will be included, selected by consecutive sampling in two primary care centers. Measurements and intervention: Physical activity, body composition, BMI and health-related quality of life will be evaluated. The intervention group will receive an intensive program of combined exercise for 6 months and use during this period a Smartband, in order to encourage and increase physical activity and decrease sedentary lifestyle

Official Title
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Effectiveness of an Intensive Intervention to Improve Physical Activity in Postmenopausal and Sedentary Women

Conditions
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Healthy

Intervention / Treatment
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* Behavioral: Control
* Behavioral: Intervention group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women in postmenopausal period defined as 12 consecutive months of amenorrhea. Exclusion Criteria: Older than 70 years are excluded, due to difficulties in the use of Information and Communication Technologies. History of cardiovascular events (acute myocardial infarction, stroke, etc). Diagnosis of clinically demonstrable neurological and/or neuropsychological disease. Muscular-skeletal pathology that inhibit mobility. Those with any other circumstance that the investigators consider could interfere with the study procedures.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Counseling on physical activity | Behavioral: Control<br>* Counseling on physical activity<br>|
| Experimental: Intervention<br>Add an intensive program of combined exercise for 6 months and use during this period a Smartband, in order to encourage and increase physical activity and decrease sedentary lifestyle | Behavioral: Control<br>* Counseling on physical activity<br>Behavioral: Intervention group<br>* Program of combined exercise and a Smartband for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Physical activity, will be measured using an accelerometer | 6 months | 
| Self-reported physical activity | Measured by the International Physical Activity Questionary - Short Form | 6 months | 
| Self-reported sedentary | Measured by the Marshall Questionary | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Measurement by InBody 230. | 6 months | 
| Body mass index | Measurement by InBody 230 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Postmenopause, Body composition, Health education, Information and Communication Technologies