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

August 30, 2022 updated by: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Salamanca, Spain, 37003
        • Instituto Biosanitario de Salamanca. Research unit La Alamedilla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Counseling on physical activity
Behavioral: Control
Counseling on physical activity
Experimental: Intervention
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
Counseling on physical activity
Behavioral: Intervention group
Program of combined exercise and a Smartband for 6 months.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Collaborators

Castilla-León Health Service

Investigators

  • Study Chair: Luis Garcia-Ortiz, Primary Health Care Research Unit, The A

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Actual)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 30, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GRS 1823/B/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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