Clinical trial NCT05467280: WISE Project - Women's Involvement in Steady Exercise
Official title: Women's Involvement in Steady Exercise (WISE) Project
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sedentary Lifestyle
Physical Inactivity
Keywords: Sedentary Behaviors
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: European Commission
name: European Platform for Sport Innovation
name: University Union - Nikola Tesla
name: European Culture and Sport Organization
name: Kinetic Analysis
name: SPORTLAB S.S.D.A.R.L.
First posted: 2022-07-20
Enrollment: 281
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in daily steps from baseline to 3 and 6 months
timeFrame: T0(Baseline), T1 (3 months) and T2 (6 months)
Secondary outcomes:
measure: Adherence (Asistence)
timeFrame: T2 (6 months)
measure: Adherence (Retention)
timeFrame: T2 (6 months)
measure: Adherence (Duration)
timeFrame: T2 (6 months)
measure: Adherence (Intensity)
timeFrame: T2 (6 months)
measure: Change in body weight (kg) from baseline to 3 and 6 months
timeFrame: T0(Baseline), T1 (3 months) and T2 (6 months)
measure: Change in skeletal muscle mass (kg) from baseline to 3 and 6 months
timeFrame: T0(Baseline), T1 (3 months) and T2 (6 months)
measure: Change in body fat mass (kg) from baseline to 3 and 6 months
timeFrame: T0(Baseline), T1 (3 months) and T2 (6 months)
measure: Change in body mass index (BMI) (kg/m2) from baseline to 3 and 6 months
timeFrame: T0(Baseline), T1 (3 months) and T2 (6 months)
measure: Change in core strength (plank test) from baseline to 3 and 6 months
timeFrame: T0(Baseline), T1 (3 months) and T2 (6 months)
measure: Change in endurance (6 minutes walking test) from baseline to 3 and 6 months
timeFrame: T0(Baseline), T1 (3 months) and T2 (6 months)
measure: Change in the international Physical Activity Questionnaire (IPAQ) from baseline to 3 and 6 months
timeFrame: T0(Baseline), T1 (3 months) and T2 (6 months)
measure: Change in the Health Lifestyle and Personal Control Questionnaire (HLPCQ) from baseline to 3 and 6 months
timeFrame: T0(Baseline), T1 (3 months) and T2 (6 months)
measure: Change in the physical Activity Enjoyment Scale from baseline to 3 and 6 months
timeFrame: T0(Baseline), T1 (3 months) and T2 (6 months)
measure: Change in period pain (hours) from baseline to 3 and 6 months
timeFrame: T0(Baseline), T1 (3 months) and T2 (6 months)
measure: Change in period pain (intensity) from baseline to 3 and 6 months
timeFrame: T0(Baseline), T1 (3 months) and T2 (6 months)
measure: Change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to 3 and 6 months
timeFrame: T0(Baseline), T1 (3 months) and T2 (6 months)
measure: Change in conditioned pain modulation (CPM) from baseline to 3 and 6 months
timeFrame: T0(Baseline), T1 (3 months) and T2 (6 months)
measure: Change in cold pain threshold from baseline to 3 and 6 months
timeFrame: T0(Baseline), T1 (3 months) and T2 (6 months)
measure: Change in cold pain inensity from baseline to 3 and 6 months
timeFrame: T0(Baseline), T1 (3 months) and T2 (6 months)
measure: Cold pain tolerance from baseline to 3 and 6 months
timeFrame: T0(Baseline), T1 (3 months) and T2 (6 months)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universitat de Valencia
Study officials:
References: