Metabolism of Obese Women Under Exercise and Recovery Hypoxia

NCT ID: NCT05380830

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-08-01

Brief Summary

Obesity is characterized as a low-grade systemic inflammatory disease, which changes several pro-and anti-inflammatory cytokines. The practice of physical activity is a non-pharmacological method that results in the reduction of the systemic inflammatory state and, when associated with hypoxia exposure, may substantially improve this state. Deep-water running is highly indicated to obese for guarantee less joint impact and lower fatigue levels. In this way, the high-intensity exercise associated with intermittent recovery hypoxia in obese women will be investigated.

Detailed Description

Obesity is characterized as a low-grade systemic inflammatory disease. With the increase in adipose tissue, several cytokines show alterations in synthesis and secretion, resulting in endocrine imbalances. The cytokines that most influence this process are adiponectin, which is anti-inflammatory and reduces its concentration during obesity. At the same time, the pro-inflammatory cytokines are tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6), which show a significant increase in the face of obesity. The practice of physical activity is a non-pharmacological method that results in the reduction of the systemic inflammatory state, altering the lipid profile and levels of both anti- and pro-inflammatory cytokines and the improvement of the individual's physical capacity. Due to the high joint overload and muscle stress, water exercises are recommended for obese individuals as it maintains motor stimulation with a low risk of injury. The training tied to running in a deep pool, also known as Deep Water Running (DWR), will promote advantages similar to running on the ground, such as improving aerobic capacity, avoiding impact and enabling the performance of exercise at high intensities lower levels of fatigue. The high-intensity exercise performance reduces the availability of oxygen to muscle cells, inducing the hypoxic environment, which causes stabilization of the hypoxia inductive factor 1 (HIF-1), promoting gene transcriptions related to erythropoiesis and angiogenesis. Thus, the present study aims to investigate the effects of high-intensity physical exercise associated with recovery hypoxia, observing both the inflammatory and lipid profile and the physical capacity of obese women grade I. For this, 45 women with obesity will participate in the study, divided into 3 groups: hypoxia, normoxia and control. All will perform body composition, food intake, hematological and lipid profile tests, plus the serum quantification of cytokines before and after the 8 weeks of physical training. Deep-water tied running (DWR) training will be periodized, high-intensity interval, with recovery in hypoxia or normoxia. Intermittent recovery hypoxia is expected to act as an additive effect on the use of oxygen by the muscle, resulting in an improvement in the hematological and lipid profile, aerobic capacity and changes in the inflammatory profile in obese women.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

The group will be only submitted to evaluations (body composition, hematological, lipid and cytokines profile, food intake, and maximal effort under treadmill and deep-water running) at the beginning and the end of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group Hypoxia

During the intervention of 8 weeks the participants will have the deep-water running training under normoxia, but during the rest they will be under hypoxia (FiO2=13%).

Group Type: EXPERIMENTAL

Tied deep-Water Running

Intervention Type: OTHER

4 efforts of tied deep-water running for 5 minutes at 100-110%Vo2max under normoxia with 5 minutes of passive rest under hypoxia (FiO2=13%) or normoxia (FiO2= 20%). Frequency: 3x/week for 8 weeks.

Group Normoxia

During the intervention of 8 weeks the participants will have the deep-water running training under normoxia, and during the rest they will keep under normoxia (FiO2=20%).

Group Type: PLACEBO_COMPARATOR

Tied deep-Water Running

Intervention Type: OTHER

4 efforts of tied deep-water running for 5 minutes at 100-110%Vo2max under normoxia with 5 minutes of passive rest under hypoxia (FiO2=13%) or normoxia (FiO2= 20%). Frequency: 3x/week for 8 weeks.

Interventions

Tied deep-Water Running

4 efforts of tied deep-water running for 5 minutes at 100-110%Vo2max under normoxia with 5 minutes of passive rest under hypoxia (FiO2=13%) or normoxia (FiO2= 20%). Frequency: 3x/week for 8 weeks.

Intervention Type: OTHER

Other Intervention Names

DWR

Eligibility Criteria

Inclusion Criteria

• Women
• Age between 25 - 45 years old;
• BMI between 30 - 35kg/m²;
• Not be on a diet;
• Not be on a physical activity program;
• Not be menopaused.

Exclusion Criteria

• Smokers;
• Alcoholics;
• Use thyroid medication;
• Carry out nutritional monitoring or in treatment for weight loss;
• Hypertension;
• Metabolical syndrome;
• Have any comorbidity associated to obesity;
• Drugs use.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ellen Cristini de Freitas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcela C Lima Viliod

Role: PRINCIPAL_INVESTIGATOR

USP

Locations

University of São Paulo, School of Physical Education and Sports of Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

Other Identifiers

DWR_Hypoxia

Identifier Type: -

Identifier Source: org_study_id