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Clinical Trials/NCT03872258
NCT03872258
Completed
Not Applicable

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

Fundacion para la Investigacion y Formacion en Ciencias de la Salud1 site in 1 country100 target enrollmentApril 1, 2019
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Enrollment
100
Locations
1
Primary Endpoint
Physical activity
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
May 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Physical activity

Time Frame: 6 months

Physical activity, will be measured using an accelerometer

Self-reported physical activity

Time Frame: 6 months

Measured by the International Physical Activity Questionary - Short Form

Self-reported sedentary

Time Frame: 6 months

Measured by the Marshall Questionary

Secondary Outcomes

  • Body composition(6 months)
  • Body mass index(6 months)

Study Sites (1)

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