NCT03872258

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

1.8 years

First QC Date

March 11, 2019

Last Update Submit

August 30, 2022

Conditions

Healthy

Keywords

Physical activityPostmenopauseBody compositionHealth educationInformation and Communication Technologies

Outcome Measures

Primary Outcomes (3)

  • Physical activity

    Physical activity, will be measured using an accelerometer

    6 months

  • Self-reported physical activity

    Measured by the International Physical Activity Questionary - Short Form

    6 months

  • Self-reported sedentary

    Measured by the Marshall Questionary

    6 months

Secondary Outcomes (2)

  • Body composition

    6 months

  • Body mass index

    6 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Counseling on physical activity

Behavioral: Control

Intervention

EXPERIMENTAL

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: ControlBehavioral: Intervention group

Interventions

ControlBEHAVIORAL

Counseling on physical activity

ControlIntervention
Intervention groupBEHAVIORAL

Program of combined exercise and a Smartband for 6 months.

Intervention

Eligibility Criteria

Age45 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women in postmenopausal period defined as 12 consecutive months of amenorrhea.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Biosanitario de Salamanca. Research unit La Alamedilla

Salamanca, 37003, Spain

Location

Related Publications (1)

  • Alonso-Dominguez R, Sanchez-Aguadero N, Llamas-Ramos I, Lugones-Sanchez C, Gonzalez-Sanchez S, Gomez-Marcos MA, Garcia-Ortiz L; Ewomen Investigators. Effect of an intensive intervention on the increase of physical activity and the decrease of sedentary lifestyle in inactive postmenopausal. J Adv Nurs. 2021 Apr;77(4):2064-2072. doi: 10.1111/jan.14737. Epub 2021 Jan 22.

    PMID: 33481300DERIVED

MeSH Terms

Conditions

Motor ActivityHealth Education

Condition Hierarchy (Ancestors)

BehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Luis Garcia-Ortiz

    Primary Health Care Research Unit, The A

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 13, 2019

Study Start

April 1, 2019

Primary Completion

December 31, 2020

Study Completion

May 31, 2021

Last Updated

August 31, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)