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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03872258
Enrollment
100
Registered
2019-03-13
Start date
2019-04-01
Completion date
2021-05-31
Last updated
2022-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Physical activity, Postmenopause, Body composition, Health education, Information and Communication Technologies

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

Interventions

BEHAVIORALControl

Counseling on physical activity

BEHAVIORALIntervention group

Program of combined exercise and a Smartband for 6 months.

Sponsors

Castilla-León Health Service
CollaboratorOTHER
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Physical activity6 monthsPhysical activity, will be measured using an accelerometer
Self-reported physical activity6 monthsMeasured by the International Physical Activity Questionary - Short Form
Self-reported sedentary6 monthsMeasured by the Marshall Questionary

Secondary

MeasureTime frameDescription
Body composition6 monthsMeasurement by InBody 230.
Body mass index6 monthsMeasurement by InBody 230

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026