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

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Status: Completed

Conditions: Healthy

Treatments: Behavioral: Intervention group; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03872258

GRS 1823/B/18

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: Female

Ages: 45 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Control

Active Comparator group

Description:

Counseling on physical activity

Treatment:

Behavioral: Control

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Intervention group

Behavioral: Control