NCT05642169

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 18, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

December 8, 2022

Status Verified

November 1, 2022

Enrollment Period

3 months

First QC Date

November 18, 2022

Last Update Submit

November 30, 2022

Conditions

Keywords

HIITIGF-1young adultwomen

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Body composition

    Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).

  • Maximum oxygen consumption

    Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).

  • Physical activity and sedentary behaviour

    Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).

  • SF-36 quality of life.

    Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).

  • Rosenberg self-esteem scale.

    Up to 12 weeks (post) and through study completion, an average of 24 weeks (Follow-Up).

  • +6 more secondary outcomes

Study Arms (3)

HIIT

EXPERIMENTAL

Training program for 12 weeks with a frequency of 3 workouts per week.

Behavioral: HIIT

HIIT+AF

EXPERIMENTAL

They will develop the same training program as the HIIT group, and they will also have to perform 10,000 steps per day.

Behavioral: HIIT+PA

Control

PLACEBO COMPARATOR

They will not suffer any change in their lifestyle.

Behavioral: CON

Interventions

HIITBEHAVIORAL

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
HIIT+PABEHAVIORAL

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.

HIIT+AF
CONBEHAVIORAL

This group will not suffer any changes in their lifestyle

Control

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThere are gender differences in the practice of physical activity, being lower in women than in men in young adults. This leads to changes in different aspects, such as quality of life, physical and mental health. Among the state of mental health, differences have been observed in executive functions between men and women, sometimes being more reduced in the latter.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Education Faculty

Seville, 41013, Spain

RECRUITING

Related 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(1):302. doi: 10.3390/ijerph18010302.

Related Links

MeSH Terms

Conditions

Insulin-Like Growth Factor I Deficiency

Study Officials

  • Manuel Jesus Jimenez Roldan

    University of Seville

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Jesús Jiménez Roldán

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 18, 2022

First Posted

December 8, 2022

Study Start

October 15, 2022

Primary Completion

January 15, 2023

Study Completion

April 15, 2023

Last Updated

December 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations