Clinical trial NCT03872258: Effectiveness of an Intensive Intervention to Improve Physical Activity in Postmenopausal and Sedentary Women
Official title: Effectiveness of an Intensive Intervention to Improve Physical Activity in Postmenopausal and Sedentary Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Physical activity
Postmenopause
Body composition
Health education
Information and Communication Technologies
Lead sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Sponsor class: OTHER
Collaborators: name: Castilla-León Health Service
First posted: 2019-03-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: Physical activity
timeFrame: 6 months
measure: Self-reported physical activity
timeFrame: 6 months
measure: Self-reported sedentary
timeFrame: 6 months
Secondary outcomes:
measure: Body composition
timeFrame: 6 months
measure: Body mass index
timeFrame: 6 months
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Instituto Biosanitario de Salamanca. Research unit La Alamedilla
Study officials:
affiliation: Primary Health Care Research Unit, The A
name: Luis Garcia-Ortiz
role: STUDY_CHAIR
References:
citation: 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.