Sedentary LifestyleNCT05467280
WISE Project - Women's Involvement in Steady Exercise
A study testing Online HIIT Intervention in people with Sedentary Lifestyle and Physical Inactivity, run by University of Valencia at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle, Physical Inactivity
- What is being tested?
- Online HIIT Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteSpain
- Study dates
- 5 Aug 2022to Feb 2023
- 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 15 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants aged between 15 and 24 years.
- 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).
Who cannot join
- Participants with diabetes.
- 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)
- Participants who are not willing to wear the watch during the 6 months that the intervention lasts.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sedentary Lifestyle, Physical Inactivity
- Being tested
- Online HIIT Intervention
- Keywords
- Sedentary Behaviors
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online HIIT InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Online HIIT Intervention |
| Control | No intervention | They will not carry out any type of intervention, they will only be monitored during the 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily steps from baseline to 3 and 6 months
Measured as the daily step count assessed via the Xiaomi Mi Band 5
Measured: T0(Baseline), T1 (3 months) and T2 (6 months)
Secondary outcomes (20)
Adherence (Asistence)
Exercise diary, asking the participants if they have completed the exercise each session
Measured: T2 (6 months)
Adherence (Retention)
Number of participants who are still following the WISE exercise videos or the follow-up measurements
Measured: T2 (6 months)
Adherence (Duration)
Number of participants who had done a minimum of 20 minutes of exercise two times a week.
Measured: T2 (6 months)
Adherence (Intensity)
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.
Measured: T2 (6 months)
Change in body weight (kg) from baseline to 3 and 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).
Measured: T0(Baseline), T1 (3 months) and T2 (6 months)
Change in skeletal muscle mass (kg) from baseline to 3 and 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).
Measured: T0(Baseline), T1 (3 months) and T2 (6 months)
Change in body fat mass (kg) from baseline to 3 and 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).
Measured: T0(Baseline), T1 (3 months) and T2 (6 months)
Change in body mass index (BMI) (kg/m2) from baseline to 3 and 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).
Measured: T0(Baseline), T1 (3 months) and T2 (6 months)
Change in core strength (plank test) from baseline to 3 and 6 months
Messured in seconds via the plank test protocol
Measured: T0(Baseline), T1 (3 months) and T2 (6 months)
Change in endurance (6 minutes walking test) from baseline to 3 and 6 months
Meters
Measured: T0(Baseline), T1 (3 months) and T2 (6 months)
Change in the international Physical Activity Questionnaire (IPAQ) from baseline to 3 and 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.
Measured: 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
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)
Measured: T0(Baseline), T1 (3 months) and T2 (6 months)
Change in the physical Activity Enjoyment Scale from baseline to 3 and 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)
Measured: T0(Baseline), T1 (3 months) and T2 (6 months)
Change in period pain (hours) from baseline to 3 and 6 months
Total hours of pain the participants has during their period
Measured: T0(Baseline), T1 (3 months) and T2 (6 months)
Change in period pain (intensity) from baseline to 3 and 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.
Measured: T0(Baseline), T1 (3 months) and T2 (6 months)
Change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to 3 and 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.
Measured: T0(Baseline), T1 (3 months) and T2 (6 months)
Change in conditioned pain modulation (CPM) from baseline to 3 and 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
Measured: T0(Baseline), T1 (3 months) and T2 (6 months)
Change in cold pain threshold from baseline to 3 and 6 months
The second when the participant sense pain in the cold pressor test.
Measured: T0(Baseline), T1 (3 months) and T2 (6 months)
Change in cold pain inensity from baseline to 3 and 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
Measured: T0(Baseline), T1 (3 months) and T2 (6 months)
Cold pain tolerance from baseline to 3 and 6 months
Second where the girls take the hand out of the water container in the cold pressor test
Measured: T0(Baseline), T1 (3 months) and T2 (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start5 Aug 2022
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies 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
- Investigator
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, European Platform for Sport Innovation, University Union - Nikola Tesla, European Culture and Sport Organization, Kinetic Analysis, SPORTLAB S.S.D.A.R.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467280
- Sponsor's protocol ID
- 1944476
- Status last verified
- Jun 2022
- First submitted
- 29 Jun 2022
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Involvement in Steady Exercise (WISE) Project
- ClinicalTrials.gov ID
- NCT05467280
- Acronym / sponsor ID
- 1944476
- Conditions
- Sedentary Lifestyle, Physical Inactivity
- Keywords
- Sedentary Behaviors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 281 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- European Commission, European Platform for Sport Innovation, University Union - Nikola Tesla, European Culture and Sport Organization, Kinetic Analysis, SPORTLAB S.S.D.A.R.L.
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 20 Jul 2022 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Online HIIT InterventionThey 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. |
| Control | No intervention | –They will not carry out any type of intervention, they will only be monitored during the 6 months |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Participants aged between 15 and 24 years.
- 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:
Key exclusion criteria (4 listed)
- Participants with diabetes.
- 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)
- Participants who are not willing to wear the watch during the 6 months that the intervention lasts.
- 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.
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 |
|---|---|---|
| Online HIIT InterventionThey 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 | Intervention |
Primary outcome
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
20 secondary outcomes
Adherence (Asistence)
Time frame: T2 (6 months)
Adherence (Retention)
Time frame: T2 (6 months)
Adherence (Duration)
Time frame: T2 (6 months)
Adherence (Intensity)
Time frame: 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)
Change in skeletal muscle mass (kg) from baseline to 3 and 6 months
Time frame: 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)
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)
Change in core strength (plank test) from baseline to 3 and 6 months
Time frame: 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)
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)
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)
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)
Change in period pain (hours) from baseline to 3 and 6 months
Time frame: 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)
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)
Change in conditioned pain modulation (CPM) from baseline to 3 and 6 months
Time frame: 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)
Change in cold pain inensity from baseline to 3 and 6 months
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online HIIT Intervention in people with Sedentary Lifestyle and Physical Inactivity, run by University of Valencia 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Feb 2023. 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?
Results are not available in the source record.
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?
Change in daily steps from baseline to 3 and 6 months (time frame: T0(Baseline), T1 (3 months) and T2 (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2023.