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OpenTrials
Completed

NCT Number: NCT03872258

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

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.

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Key information

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Biosanitario de Salamanca. Research unit La Alamedilla

Salamanca, 37003, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control

Behavioral

Counseling on physical activity

Intervention Group

Behavioral

Program of combined exercise and a Smartband for 6 months.

Primary outcomes

  1. Physical activity

    Time frame: 6 months

    Physical activity, will be measured using an accelerometer

  2. Self-reported physical activity

    Time frame: 6 months

    Measured by the International Physical Activity Questionary - Short Form

  3. Self-reported sedentary

    Time frame: 6 months

    Measured by the Marshall Questionary

Secondary outcomes

  1. Body composition

    Time frame: 6 months

    Measurement by InBody 230.

  2. Body mass index

    Time frame: 6 months

    Measurement by InBody 230

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Other

Collaborators

  • Castilla-León Health Service

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 13, 2019
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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