WISE Project - Women's Involvement in Steady Exercise

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: Active, not recruiting
• Conditions: Sedentary Lifestyle; Physical Inactivity
• Intervention / Treatment: Other: Online HIIT Intervention

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: Interventional
• Enrollment (Actual): 281
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in daily steps from baseline to 3 and 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

Outcome Measure	Measure Description	Time Frame
Adherence (Asistence)	Exercise diary, asking the participants if they have completed the exercise each session	T2 (6 months)
Adherence (Retention)	Number of participants who are still following the WISE exercise videos or the follow-up measurements	T2 (6 months)
Adherence (Duration)	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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)	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	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

• Sponsor: University of Valencia
• Collaborators: 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

Study Major Dates

• Study Start (Actual): August 5, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Sedentary Behaviors
• Other Study ID 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