HealthyNCT03872258
Effectiveness of an Intensive Intervention to Improve Physical Activity in Postmenopausal and Sedentary Women
A study testing Intervention group in people with Healthy, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2019to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women in postmenopausal period defined as 12 consecutive months of amenorrhea.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto Biosanitario de Salamanca. Research unit La Alamedilla
Salamanca, 37003
About this study
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.
Read the 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
- Conditions
- Healthy
- Being tested
- Control, Intervention group
- Keywords
- Physical activity, Postmenopause, Body composition, Health education, Information and Communication Technologies
- Medical subject headings
- Motor Activity, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
Counseling on physical activity
Intervention groupBehavioural
Program of combined exercise and a Smartband for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Counseling on physical activity Receives: 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 Receives: Behavioral: Control; Behavioral: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Physical activity, will be measured using an accelerometer
Measured: 6 months
Self-reported physical activity
Measured by the International Physical Activity Questionary - Short Form
Measured: 6 months
Self-reported sedentary
Measured by the Marshall Questionary
Measured: 6 months
Secondary outcomes (2)
Body composition
Measurement by InBody 230.
Measured: 6 months
Body mass index
Measurement by InBody 230
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start1 Apr 2019
- Primary completion31 Dec 2020
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Castilla-León Health Service
- Responsible party
- Sponsor
- Investigators
- Luis Garcia-Ortiz, Study chair, Primary Health Care Research Unit, The A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872258
- Sponsor's protocol ID
- GRS 1823/B/18
- Status last verified
- Aug 2022
- First submitted
- 11 Mar 2019
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33481300
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Intensive Intervention to Improve Physical Activity in Postmenopausal and Sedentary Women
- ClinicalTrials.gov ID
- NCT03872258
- Acronym / sponsor ID
- GRS 1823/B/18
- Conditions
- Healthy
- Keywords
- Physical activity, Postmenopause, Body composition, Health education, Information and Communication Technologies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Collaborators
- Castilla-León Health Service
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ControlCounseling on physical activity |
| Intervention | Experimental | Behavioral: Control, Behavioral: Intervention groupAdd 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 |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women in postmenopausal period defined as 12 consecutive months of amenorrhea.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlCounseling on physical activity | Behavioural | Control, Intervention |
| Intervention groupProgram of combined exercise and a Smartband for 6 months. | Behavioural | Intervention |
Primary outcome
Physical activity
Time frame: 6 months
Physical activity, will be measured using an accelerometer
Self-reported physical activity
Time frame: 6 months
Measured by the International Physical Activity Questionary - Short Form
Self-reported sedentary
Time frame: 6 months
Measured by the Marshall Questionary
2 secondary outcomes
Body composition
Time frame: 6 months
Body mass index
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Derived from this study: PubMed 33481300Alonso-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Garcia-Ortiz study chair
Primary Health Care Research Unit, The A
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Healthy, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03872258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.