WISE Project - Women's Involvement in Steady Exercise

Physical Inactivity Clinical Trial

Official title:

Women's Involvement in Steady Exercise (WISE) Project

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05467280
• Other study ID #: 1944476
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 5, 2022
• Est. completion date: February 2023

Study information

• Verified date: June 2022
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 281
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Inactivity
• Sedentary Lifestyle

Intervention

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.

Locations

Country	Name	City	State
Spain	Universitat de Valencia	Valencia

Sponsors (7)

Lead Sponsor	Collaborator
University of Valencia	European Commission, European Culture and Sport Organization, European Platform for Sport Innovation, Kinetic Analysis, SPORTLAB S.S.D.A.R.L., University Union - Nikola Tesla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adherence (Asistence)	Exercise diary, asking the participants if they have completed the exercise each session	T2 (6 months)
Secondary	Adherence (Retention)	Number of participants who are still following the WISE exercise videos or the follow-up measurements	T2 (6 months)
Secondary	Adherence (Duration)	Number of participants who had done a minimum of 20 minutes of exercise two times a week.	T2 (6 months)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Change in endurance (6 minutes walking test) from baseline to 3 and 6 months	Meters	T0(Baseline), T1 (3 months) and T2 (6 months)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)