WISE Project - Women's Involvement in Steady Exercise

February 15, 2023 updated by: University of Valencia

Women's Involvement in Steady Exercise (WISE) Project

The general objective is to assess adherence to a HIIT-type exercise program, complemented with nutritional plans and other health-related advice, which will be administered through a mobile application in sedentary girls.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The project is aimed at encouraging participation in sport and physical activity, especially by supporting the implementation of the Council Recommendation on health-enhancing physical activity and being in line with the EU Physical Activity Guidelines, since its main objective is to determine the influence of exercise and healthy lifestyle on body composition of young women aged 15-24 and to define a specific WISE Exercise Programme - a multidimensional model of dependence between body composition, lifestyle and nutrition which would enable the programming of optimal patterns of behaviour in life habits as a planned corrective measure and stimulate the young women in EU countries to avoid the drop out of sports.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
281

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46020
        • Universitat de Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Participants aged between 15 and 24 years.

  2. Sedentary participants who do not comply with the WHO physical exercise recommendations and with a low IPAQ, which means that they do not perform at least:

    • 3 or more days of vigorous activity for at least 20 minutes a day.
    • 5 or more days of moderate-intensity activity.
    • Walk at least 30 minutes a day every day.
    • 5 or more days of combined moderate or vigorous intensity activities or walking achieved a minimum of 600 METs(min/week).

Exclusion Criteria:

  1. Participants with diabetes.
  2. Participants with possible heart problems or other type of contraindication that does not allow physical exercise (for this, the PAR-Q survey will be passed)
  3. Participants who are not willing to wear the watch during the 6 months that the intervention lasts.
  4. Participants who have contracted severe COVID-19 in the last 3 months. If the patients suffer from COVID-19 during the study, then they will stop exercising, but the measurements will be taken at the end of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
They will be given HIIT exercise video sessions twice a week for 6 months, through a mobile application where they will also be given nutritional and health advice, webinars, and challenges.
Other: Online HIIT Intervention
They will be given HIIT exercise video sessions twice a week for 6 months, through a mobile application where they will also be given nutritional and health advice, webinars and challenges.
No Intervention: Control
They will not carry out any type of intervention, they will only be monitored during the 6 months

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in daily steps from baseline to 3 and 6 months
Time Frame: T0(Baseline), T1 (3 months) and T2 (6 months)
Measured as the daily step count assessed via the Xiaomi Mi Band 5
T0(Baseline), T1 (3 months) and T2 (6 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence (Asistence)
Time Frame: T2 (6 months)
Exercise diary, asking the participants if they have completed the exercise each session
T2 (6 months)
Adherence (Retention)
Time Frame: T2 (6 months)
Number of participants who are still following the WISE exercise videos or the follow-up measurements
T2 (6 months)
Adherence (Duration)
Time Frame: T2 (6 months)
Number of participants who had done a minimum of 20 minutes of exercise two times a week.
T2 (6 months)
Change in body weight (kg) from baseline to 3 and 6 months
Time Frame: T0(Baseline), T1 (3 months) and T2 (6 months)
Assessment of body weight (kg) is conducted using bioelectrical impedance analysis with the multi frequency segmented body composition analyzer InBody 230 (InBodyUSA, Cerritos, CA).
T0(Baseline), T1 (3 months) and T2 (6 months)
Change in skeletal muscle mass (kg) from baseline to 3 and 6 months
Time Frame: T0(Baseline), T1 (3 months) and T2 (6 months)
Assessment of skeletal muscle mass (kg) is conducted using bioelectrical impedance analysis with the multi frequency segmented body composition analyzer InBody 230 (InBodyUSA, Cerritos, CA).
T0(Baseline), T1 (3 months) and T2 (6 months)
Change in body fat mass (kg) from baseline to 3 and 6 months
Time Frame: T0(Baseline), T1 (3 months) and T2 (6 months)
Assessment of body fat mass (kg) is conducted using bioelectrical impedance analysis with the multi frequency segmented body composition analyzer InBody 230 (InBodyUSA, Cerritos, CA).
T0(Baseline), T1 (3 months) and T2 (6 months)
Change in body mass index (BMI) (kg/m2) from baseline to 3 and 6 months
Time Frame: T0(Baseline), T1 (3 months) and T2 (6 months)
Assessment of BMI (kg/m2) is conducted using bioelectrical impedance analysis with the multi frequency segmented body composition analyzer InBody 230 (InBodyUSA, Cerritos, CA).
T0(Baseline), T1 (3 months) and T2 (6 months)
Change in core strength (plank test) from baseline to 3 and 6 months
Time Frame: T0(Baseline), T1 (3 months) and T2 (6 months)
Messured in seconds via the plank test protocol
T0(Baseline), T1 (3 months) and T2 (6 months)
Change in endurance (6 minutes walking test) from baseline to 3 and 6 months
Time Frame: T0(Baseline), T1 (3 months) and T2 (6 months)
Meters
T0(Baseline), T1 (3 months) and T2 (6 months)
Change in the international Physical Activity Questionnaire (IPAQ) from baseline to 3 and 6 months
Time Frame: T0(Baseline), T1 (3 months) and T2 (6 months)
The IPAQ assesses walking and activities of a moderate and vigorous intensity that are per-formed continuously for at least 10 min in all domains of everyday life (i.e. leisure, occupa-tional, household and transport) in the last 7 days.
T0(Baseline), T1 (3 months) and T2 (6 months)
Change in the Health Lifestyle and Personal Control Questionnaire (HLPCQ) from baseline to 3 and 6 months
Time Frame: T0(Baseline), T1 (3 months) and T2 (6 months)
This is a 26-item tool in which the respondent is asked to indicate the frequency of adopting 26 positively stated lifestyle habits using a Likert-type scale (1 = Never or rarely, 2 = Sometimes, 3 = Often and 4 = Always)
T0(Baseline), T1 (3 months) and T2 (6 months)
Change in the physical Activity Enjoyment Scale from baseline to 3 and 6 months
Time Frame: T0(Baseline), T1 (3 months) and T2 (6 months)
Is an 18-item scale that assesses enjoyment for physical activity by asking participants to rate "how you feel at the moment about the physical activity you have been doing" using a 7- point bipolar Likert scale, from 1 (I enjoy it) to 7 (I hate it)
T0(Baseline), T1 (3 months) and T2 (6 months)
Change in period pain (hours) from baseline to 3 and 6 months
Time Frame: T0(Baseline), T1 (3 months) and T2 (6 months)
Total hours of pain the participants has during their period
T0(Baseline), T1 (3 months) and T2 (6 months)
Change in period pain (intensity) from baseline to 3 and 6 months
Time Frame: T0(Baseline), T1 (3 months) and T2 (6 months)
Pain intensity will be measured using the visual analogue scale (VAS). A 100-millimeter line bounded by ''no pain'' on the left (0) and ''worst pain possible'' (100) on the right will be used to indicate the average pain during the period.
T0(Baseline), T1 (3 months) and T2 (6 months)
Change in conditioned pain modulation (CPM) from baseline to 3 and 6 months
Time Frame: T0(Baseline), T1 (3 months) and T2 (6 months)
Assessment of CPM in clinical practice can document the (in)efficacy of the endogenous anti-nociceptive system. we analyzed the effect that CPM had through the cold pressure test and pressure pain thresolds of the quadriceps
T0(Baseline), T1 (3 months) and T2 (6 months)
Change in cold pain threshold from baseline to 3 and 6 months
Time Frame: T0(Baseline), T1 (3 months) and T2 (6 months)
The second when the participant sense pain in the cold pressor test.
T0(Baseline), T1 (3 months) and T2 (6 months)
Change in cold pain inensity from baseline to 3 and 6 months
Time Frame: T0(Baseline), T1 (3 months) and T2 (6 months)
Level of pain brought on by the cold water on a 0 to 10 numerical rating scale (NRS), where 0 is regarded as no pain and 10 is the most agonizing pain imaginable. Measured just before the hand is removed from the water in the cold pressor test
T0(Baseline), T1 (3 months) and T2 (6 months)
Cold pain tolerance from baseline to 3 and 6 months
Time Frame: T0(Baseline), T1 (3 months) and T2 (6 months)
Second where the girls take the hand out of the water container in the cold pressor test
T0(Baseline), T1 (3 months) and T2 (6 months)
Adherence (Intensity)
Time Frame: T2 (6 months)
Exercise diary, asking the participants their perceived exertion of the sessions via the modified Borg Scale after they just done it. The Borg Rating of Perceived Exertion is a way of measuring physical activity intensity level. A 0-10 scales is used where 0 is no perceived exertion (rest) and 10 is maximal perceived exertion.
T2 (6 months)
Change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to 3 and 6 months
Time Frame: T0(Baseline), T1 (3 months) and T2 (6 months)
Is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
T0(Baseline), T1 (3 months) and T2 (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Valencia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
European Commission
European Platform for Sport Innovation
European Culture and Sport Organization
Kinetic Analysis
SPORTLAB S.S.D.A.R.L.
University Union - Nikola Tesla

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1944476

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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