Effect of a HIIT Program on Quality of Life, Executive Functions, and IGF-1 Response in Sedentary Young University Women

Executive Function Disorder Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05642169
• Other study ID #: Young Brain Proyect
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: April 15, 2023

Study information

• Verified date: November 2022
• Source: University of Seville
• Contact: Manuel Jesús Jiménez Roldán
• Phone: 650344644
• Email: manueljr[@]euosuna.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: April 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Executive Function Disorder
• IGF1 Deficiency

Intervention

Behavioral:
• HIIT
The training sessions will have a frequency of 3 times per week (Monday, Wednesday and Friday) and the duration will be between 39 to 54 minutes, depending on the training week. The training program will be developed with the own body weight of each participant. Therefore, a progression according to the needs of this population will be fulfilled. The session model could be multi-joint exercises with self-loads, where the difficulty of the exercises will be worked progressively. Throughout the main part of each workout, 30 seconds of work will be performed at the corresponding intensity and 30 seconds of rest. Halfway through the total repetitions, there will be 2 minutes of recovery.
• HIIT+PA
In relation to the 2 groups that will perform HIIT, the HIIT+AF will have to complete 10.000 steps per day. In this way, they will be focusing on increasing their daily physical activity. In addition, this group will perform the same HIIT training programme as the other experimental group.
• CON
This group will not suffer any changes in their lifestyle

Locations

Country	Name	City	State
Spain	Education Faculty	Seville

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical determinants	The main biochemical determinants established in this study will be measured in saliva. Thus, the magnitude of the IGF-1 response in saliva as a consequence of the execution of a 12-week HIIT training program will be analyzed. In addition, the acute response to maximal effort will be measured at the initial and final assessments.; Saliva will be collected in a fasted state (between 8-12 hours) and the passive drooling method will be used. At each assessment, a saliva sample will be obtained at rest and after maximal effort.; To measure the variability in each assessment of IGF-1 concentration in saliva, the ELISA KIT protocol will be used.	Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
Secondary	Body composition	Body composition will be measured by taking waist and hip perimeters and through electrical bioimpedance (BIA). This is a fast and non-invasive technique in which different body composition variables are estimated. Such a tool becomes a reliable system with scientific validity (Kelly & Metcalfe, 2012).; The BIA used in this investigation (Tanita BC-418, Tokyo, Japan) is a segmental measurement. The subject is placed in a standing position on 4 electrodes, located on the feet and hands, where through two of them an alternating current is introduced and the remaining two collect this current, measuring, among others, the values of impedance, resistance and body reactance.	Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
Secondary	Maximum oxygen consumption	Maximum oxygen consumption (VO2max) will be estimated from the maximum power output (MPO) achieved in an incremental cycloergometer test (Andersen, 1995). Therefore, only the MPO will be taken into account for its estimation, since it is a measure of the capacity of the cardiorespiratory system, which can predict 80% of the variation in VO2max.; The development of the test begins with a first part of 7 minutes at a submaximal load of 69W. At the end of this phase the heart rate was recorded with a pulsometer (H10 Polar Electro OY, Finalandia). The load will be increased by 35W every 2 minutes until the subject reached exhaustion.	Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
Secondary	Physical activity and sedentary behaviour	Physical activity will be evaluated objectively by accelerometry. The accelerometer is a device that allows objective quantification of the physical activity performed by a person. The study population was asked to wear a triaxial accelerometer (GTX3, Penascola, Florida, USA).; Participants were instructed to wear the accelerometer throughout the day (24h). The placement of the accelerometer during the recording days should be on the right side at hip height and in line with the anterior face of the ipsilateral lower extremity. To avoid damage to the device, it was removed in any aquatic situation. On this occasion, a record sheet was provided for its annotation.	Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
Secondary	SF-36 quality of life.	To detect changes in health-related quality of life, the SF-36 questionnaire will be used. This questionnaire, in its Spanish versión (Vilagut et al., 2005), focuses on assessing general health status through a generic scale. This provides a profile of quality of life, both of a general population and of specific subgroups.; This questionnaire consists of a total of 36 questions covering 8 health concepts. In addition, there are two summary measures, which are physical health and mental health. Mental health is divided into the vitality scale (4 items), social functioning (2), emotional role (3) and mental health (5). On the other hand, physical health encompasses physical capacity (10 items), physical role (4), bodily pain (2) and general health (5). In addition, two global questions on the perception of their health are added.; The scores for each scale range from 0 to 100, with higher scores indicating a better quality of life	Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
Secondary	Rosenberg self-esteem scale.	The Rosenberg self-esteem scale (1965) is the most widely used test for the evaluation of self-esteem in scientific research and clinical practice.; This test is a 10-item scale for analyzing global self-esteem (Vázquez Morejón et al., 2004). Each item is classified on a 4-point Likert scale, where 1 is equivalent to "strongly disagree" and 4 to "strongly agree". Of the 10 questions asked, five are formulated positively and five negatively (2,5,8,9,10). In addition, each question measures the degree of satisfaction of the person together with the person's self-assessment.; In relation to the results, the unifactorial nature proposed by Rosenberg has been questioned; however, other authors support a bifactorial structure of positive and negative self-esteem. According to the validation study of this work in Spanish (Atienza et al., 2000), when the sample is made up of women, the elaboration of a single factor of global self-esteem is suggested.	Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
Secondary	Hamilton Rating Scale for the Evaluation of Depression (HDRS).	The HDRS (Hamilton, 1960) is a scale for assessing depression. It is hetero-applicable and is designed with the aim of quantitatively assessing the degree of depression of the interviewed subject.; The original version consists of 21 questions, but on this occasion the reduced versión (Hamilton, 1967) published later will be used. This version consists of 17 questions, which is recommended for clinical use.; The short version of the HDRS has been validated in the Spanish version (Ramos-Brieva & Cordero Villafáfila, 1986) showing high reliability and sensitivity to change in different populations (Ramos-Brieva & Cordero-Villafafila, 1988).	Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
Secondary	Executive functions	The measurements of the following cognitive tests will be performed with the collaboration of a psychologist specialized in the execution and description of the following executive tests: For the evaluation of inhibitory control, the Stroop testT will be used (Golden, 1999). This is a neuropsychological test that measures the interference generated in the performance of a task. In this work, the Victoria version will be developed in a digitized form (Mueller et al., 2012).; For the evaluation of cognitive flexibility, wil be used the Wisconsin card test (WCST) (Cepeda et al., 2000). It can be performed traditionally or, as in this case, digitally. This test consists of a total of 64 cards. The cards present different combinations according to 4 geometric shapes, 4 colors and 4 quantities.; Digit Span Test (DST) analyzes the ability to store and retain information, whose mission is to measure working memory.	Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
Secondary	Lower body muscle strength	Leg extension muscle strength will be assessed on a calibrated isokinetic dynamometer (Biodex System 4, Biodex Medical System, Inc., Shirley, NY, USA). Therefore, the Biodex System 4 will be used to assess each subject's ability to generate maximal isometric power with the knee extensor musculature in a 60° flexion joint position from a seated position.; For measurement, the Biodex clinical data station will be used to analyze the Biodex torque and position signals and obtain the resulting measurements.; The performance protocol will consist of executing two maximal isometric efforts for 5 seconds. The subject, with arms crossed over the chest, will begin to perform the maximal force at the evaluator's "push" voice. Subsequently, the subject will rest 30 seconds to perform the second attempt.; Once both attempts have been completed, the best result of the peak torque variable (N-M) will be recorded for further analysis.	Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
Secondary	Upper extremity muscle strength.	Upper extremity muscle strength will be assessed through manual dynamometry testing with a digital dynamometer (TKK 5101 Grip-D; Takey, Tokyo, Japan) as described in other studies (Ruiz-Ruiz et al., 2002).; Subjects were to be placed in a bipedal position during the test with the arms in full extension and without touching any part of the body with the dynamometer, except for the hand. The positioning of the body should be at all times with the shoulder girdle parallel to the ground, without allowing flexion or lateral movement of the trunk during the application of force.; The participants will be instructed to squeeze the dynamometer grip as hard as possible and without being able to bend any of the joints involved. The duration of the effort will be 5 seconds, without being able to perform discontinuous activations, i.e., they must maintain the maximum isometric force possible during the 5 seconds.; Finally, the best result (Kg) of the two tests performed will be recorded.	Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
Secondary	Beck Depression Inventory (BDI-II)	The Beck-II (Beck & Steer, 1993) is used to measure depressive symptomatology.; It is a self-administered instrument consisting of 21 items that assess cognitive, affective and neurovegetative factors. This questionnaire is usually the most widely used in clinical psychology to assess the degree of depression (Sanz et al., 2003).; This questionnaire has been validated in the Spanish version (Sanz et al., 2005) and has also shown high reliability in a university population (Sprinkle et al., 2002).; Each item has four responses, ordered from least to most severe (from 0 to 3 points), and the subject must choose the sentence that most closely matches his or her perception during the last week. The scores of this instrument range from 0-63, with the reference cut-off points being the following: 0-9 no depression; 10-15 mild depression; 16-19 moderate depression; 20-29 moderate-severe depression; 30-63 severe depression.	Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).
Secondary	International Physical Activity Questionnaire (IPAQ).	The IPAQ questionnaire is an instrument to determine approximately the level of physical activity practiced by the general population (Hagstro et al., 2006). This questionnaire is one of the most widely used for the detection of sedentary lifestyles, used to a greater extent in its short version, adapted and translated into Spanish. In addition, this questionnaire shows excellent reliability (Craig et al., 2003) and high validity for its application in university population (Cancela et al., 2019).; Therefore, for the calculation of the IPAQ data, an average of Mets will be adopted for each type of activity, resulting as follows: walking 3.3 Mets, moderate activities 4.0 Mets and intense activities 8.0 Mets.	Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).

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