WISE Project - Women's Involvement in Steady Exercise

• Sponsor: University of Valencia (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05467280
• Collaborator: European Commission (Other), European Platform for Sport Innovation (Other), University "Union - Nikola Tesla", Faculty of Sport - FZS (Other), European Culture and Sport Organization (Other), Kinetic Analysis (Other), SPORTLAB S.S.D.A.R.L. (Other)
• Enrollment: 281
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.9
• Patients Per Site Per Month: 47.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sedentary Lifestyle; Physical Inactivity	Other: Online HIIT Intervention	N/A

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

• Study Type: Interventional
• Actual Enrollment: 281 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Women's Involvement in Steady Exercise (WISE) Project
• Actual Study Start Date: May 5, 2022
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Adherence [Once a week through study completion (6 months)]

   Exercise diary

Secondary Outcome Measures

1. Anthropometric factors with the inbody 230 [T0 baselie, T1 (3 months), T2 (6 months)]

   kg

2. Core strength (plank test) [T0 baselie, T1 (3 months), T2 (6 months)]

   Seconds

3. Upper body strenght (Hand grip) [T0 baselie, T1 (3 months), T2 (6 months)]

   Kg

4. Lower body strength (Jump test) [T0 baselie, T1 (3 months), T2 (6 months)]

   Meters

5. Endurance (6 minutes walking test) [T0 baselie, T1 (3 months), T2 (6 months)]

   Meters

6. International Physical Activity Questionnaire (IPAQ) [T0 baselie, T1 (3 months), T2 (6 months)]

   METs

7. The Health Lifestyle and Personal Control Questionnaire (HLPCQ) [T0 baselie, T1 (3 months), 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)

8. Physical Activity Enjoyment Scale [T0 baselie, T1 (3 months), 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)

9. Period pain [T0 baselie, T1 (3 months), T2 (6 months)]

   Total hours of pain, intensity of pain and location of pain

10. The Pittsburgh Sleep Quality Index (PSQI) [T0 baselie, T1 (3 months), 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 sum of scores for these seven components yields one global score.

11. Conditioned pain modulation (CPM) [T0 baselie, T1 (3 months), 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

12. Body Self-esteem Scale [T0 baselie, T1 (3 months), T2 (6 months)]

    The scale contains 26 items that assesses body self-esteem, integrating two aspects, body satisfaction and body appeal using a 10- point Likert scale, from 1 (Not satisfied) to 10 (very satisfied)

13. Rosenberg self-esteem scale [T0 baselie, T1 (3 months), T2 (6 months)]

    A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. All items are answered using a 4-point Likert scale format ranging from strongly agree to strongly disagree.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 25 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitat de Valencia	Valencia		Spain	46020

Sponsors and Collaborators

• University of Valencia
• European Commission
• European Platform for Sport Innovation
• University "Union - Nikola Tesla", Faculty of Sport - FZS
• European Culture and Sport Organization
• Kinetic Analysis
• SPORTLAB S.S.D.A.R.L.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Valencia
• ClinicalTrials.gov Identifier: NCT05467280
• Other Study ID Numbers: 1944476
• First Posted: Jul 20, 2022
• Last Update Posted: Jul 20, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Valencia: Sedentary Behaviors

Study Results

No Results Posted as of Jul 20, 2022