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

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT03872258
• Lead Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud

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

Study Timeline

• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-13
• Study Start: 2019-04-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-05-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physical activity	6 months	Physical activity, will be measured using an accelerometer
Self-reported physical activity	6 months	Measured by the International Physical Activity Questionary - Short Form
Self-reported sedentary	6 months	Measured by the Marshall Questionary

Secondary Outcome Measures

Name	Time	Method
Body composition	6 months	Measurement by InBody 230.
Body mass index	6 months	Measurement by InBody 230

Trial Locations

Locations (1)

Instituto Biosanitario de Salamanca. Research unit La Alamedilla; 🇪🇸 Salamanca, Spain