Clinical trial NCT05642169: Effect of a HIIT Program on Quality of Life, Executive Functions, and IGF-1 Response in Sedentary Young University Women
Official title: Effect of a High Interval Intensity Training Program on Quality of Life, Mental Health, Brain Executive Functions, and IGF-1 Response in Sedentary Young University Women.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insulin Growth Factor I Deficiency
IGF1 Deficiency
Executive Function Disorder
Keywords: HIIT
IGF-1
young adult
women
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present research follows a randomized controlled experimental design (RCT), sequential type, with parallel groups with three groups and repeated measures, being evaluated in a pretest, posttest and after the end of the follow-up period.

The sample, of casual or incidental type, were randomly distributed in two experimental groups and one CG, thus avoiding selection bias. The CG continued to maintain their lifestyle on a daily basis. On the other hand, we found two experimental groups, which performed a HIIT program with a frequency of 3 workouts per week. In one of them (HIIT+AF), the focus was on increasing their daily physical activity through the execution of 10,000 steps per day. The other experimental group (HIIT) followed the same HIIT program.
Primary purpose: TREATMENT

Brief summary: Sedentary lifestyle, understood as an activity that requires minimal body movement (Tremblay et al., 2017), is one of the main factors responsible for chronic diseases in Young adults.

In addition, this sedentary lifestyle generates mental disorders, such as anxiety, low self-esteem and depression, being more pronounced in women than in men (Nihill et al., 2013). Thus, both daily physical activity (PA) and physical exercise programs (PE), of moderate-vigorous intensity, act as an effective tools for the improvement of quality of life, since they generate benefits at physiological, psychological and social levels (Cohen et al., 2019).

If we focus on young adult, it can be seen how there is a significant decrease in the practice of physical exercise at this age (Grim et al., 2011). This means that the aforementioned recommendations are not reached (Cancela et al., 2019). Furthermore, if compared between sexes, lower levels are shown in the female sex (King et al., 2014).

For this reasons, and taking into account that the female population is a population vulnerable to significantly reduce their physical activity practice with age (Cohen et al., 2019), it is interesting to investigate on the possible health-related factors that this entails, such as quality of life, physical condition and mental health.

For these reasons, it is necessary to create effective strategies to address factors related to the main cognitive impairments and thus preserve better mental health.

Among all possible strategies, both pharmacological and non-pharmacological for the improvement of mental health, cognition and executive functions in young adults.Physical exercise has been shown to be a highly effective strategy at these ages (Heath et al., 2016). The stimulation of HIIT seems to reduce antioxidant responses. In recent years, there is a high interest in knowing the effect of HIIT on different health outcomes, such as physical and psychological fitness (Eather et al., 2019).

For all these reasons, sedentary lifestyles are an important public health factor associated with numerous pathologies and have been shown to have a significant cognitive involvement. Although we know that physical exercise can have a preventive role in the management of these associations, the conditioning factors of physical exercise are unknown, as well as the lifestyle factors that could contribute to a greater extent to the improvement of executive functionality in young women.

Detailed description: The present investigation follows a randomized controlled experimental design (RCT), of sequential type, with parallel groups with three groups and repeated measures, being evaluated in a pretest, posttest and after the end of the follow-up period.

The sample, of casual or incidental type, was randomly distributed in two experimental groups and a control group, thus avoiding selection bias.

Once the study population had been selected and met the established inclusion and exclusion criteria, a 12-week HIIT-based intervention was performed.

Two of the experimental groups will perform this training program with the only difference that the HIIT+PA group will have to perform 10,000 steps per day, thus increasing daily physical activity.

Among the main study variables were insulin-like growth factor-1 (IGF-1), executive functions, physical condition, physical activity, quality of life and body composition.

Eligibility criteria: Inclusion Criteria:

* Age: 18-30 years old
* Reflect in the IPAQ questionnaire to be in category 1 or low level of physical activity (Craig et al., 2003) and therefore not conform to the minimum recommendations for physical activity and physical exercise proposed by the WHO.
* Not suffering from somatic signs or serious psychiatric illnesses that prevent the practice of physical exercise.
* Not attending psychological therapies in the last 12 months prior to the study. The use of this type of treatment may have an impact on the improvement of cognitive abilities and executive functions of the study population.
* Being able to communicate.
* Informed consent: Be able and willing to give informed consent.

Exclusion Criteria:

* Having a general cognitive impairment or executive function disorder recognized and treated by specialists.
* Physical activity: In order to select sedentary subjects, we excluded those who engaged in physical activity in their leisure time in a continuous and planned manner.
* Bilingualism: Habitual and indistinct use of two or more languages. This may condition the results in various cognitive tests present in the study, since it is known that this intellectual capacity has a morphological and functional impact on the brain.
* Musical instrument: Playing a musical instrument regularly and continuously, as in the previous criterion, generates a positive effect on the subject's cognition

Primary outcomes:
measure: Biochemical determinants
timeFrame: Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
Secondary outcomes:
measure: Body composition
timeFrame: Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
measure: Maximum oxygen consumption
timeFrame: Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
measure: Physical activity and sedentary behaviour
timeFrame: Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
measure: SF-36 quality of life.
timeFrame: Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
measure: Rosenberg self-esteem scale.
timeFrame: Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
measure: Hamilton Rating Scale for the Evaluation of Depression (HDRS).
timeFrame: Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
measure: Executive functions
timeFrame: Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
measure: Lower body muscle strength
timeFrame: Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
measure: Upper extremity muscle strength.
timeFrame: Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
measure: Beck Depression Inventory (BDI-II)
timeFrame: Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
measure: International Physical Activity Questionnaire (IPAQ).
timeFrame: Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Education Faculty
Study officials:
affiliation: University of Seville
name: Manuel Jesus Jimenez Roldan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Y, Zhang B, Gan L, Ke L, Fu Y, Di Q, Ma X. Effects of Online Bodyweight High-Intensity Interval Training Intervention and Health Education on the Mental Health and Cognition of Sedentary Young Females. Int J Environ Res Public Health. 2021 Jan 3;18(1):302. doi: 10.3390/ijerph18010302.