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

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ClinicalTrials.gov Identifier: NCT03872258
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : June 19, 2019
Sponsor:
Collaborator:
Castilla-León Health Service
Information provided by (Responsible Party):
Fundacion para la Investigacion y Formacion en Ciencias de la Salud

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.

Condition or disease Intervention/treatment Phase
Healthy Behavioral: Control Behavioral: Intervention group Not Applicable

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: 200 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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of an Intensive Intervention to Improve Physical Activity in Postmenopausal and Sedentary Women
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Body composition [ Time Frame: 6 months ]
    Measurement by InBody 230.

  2. Body mass index [ Time Frame: 6 months ]
    Measurement by InBody 230



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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872258


Contacts
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Contact: Rosario Alonso 635542886 lgarciao@usal.es
Contact: Luis Garcia-Ortiz 635542886 lgarciao@usal.es

Locations
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Spain
Instituto Biosanitario de Salamanca. Research unit La Alamedilla Recruiting
Salamanca, Spain, 37003
Contact: Rosario Alonso-Dominguez    +349231859 ext 53550    rosa90alonso@hotmail.com   
Principal Investigator: Rosario Alonso Domínguez         
Sub-Investigator: Cristina Lugones Sánchez         
Sub-Investigator: Cristina Agudo Conde         
Sub-Investigator: Natalia Sánchez Aguadero         
Sub-Investigator: José Ignacio Recio Rodríguez         
Sub-Investigator: Benigna Sánchez Salgado         
Sub-Investigator: Cristina Martín Martín         
Sub-Investigator: Jesús González Sánchez         
Sub-Investigator: Carmen Castaño Sánchez         
Sponsors and Collaborators
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Castilla-León Health Service
Investigators
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Study Chair: Luis Garcia-Ortiz Primary Health Care Research Unit, The A

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Responsible Party: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
ClinicalTrials.gov Identifier: NCT03872258     History of Changes
Other Study ID Numbers: GRS 1823/B/18
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundacion para la Investigacion y Formacion en Ciencias de la Salud:
Physical activity
Postmenopause
Body composition
Health education
Information and Communication Technologies