Clinical trial NCT05380830: Metabolism of Obese Women Under Exercise and Recovery Hypoxia
Official title: Metabolic Alterations in Obese Women Undergoing High-intensity Physical Exercise Associated With Intermittent Recovery Hypoxia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Intermittent hypoxia
Metabolic disease
Deep-water running
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2022-05-19
Enrollment: 45
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Body weight changes (Anthropometry)
timeFrame: Eight weeks
measure: Height assessment (Anthropometry)
timeFrame: Eight weeks
measure: Body mass index changes (Anthropometry)
timeFrame: Eight weeks
measure: Body composition changes (Anthropometry)
timeFrame: Eight weeks
measure: Erythrogram (Hematological profile)
timeFrame: Eight weeks
measure: EPO (Hematological profile)
timeFrame: Eight weeks
measure: Lipid profile
timeFrame: Eight weeks
measure: Inflammatory profile
timeFrame: Eight weeks
measure: Changes in aerobic performance (deep-water running)
timeFrame: eight weeks
measure: Changes in aerobic performance (treadmill)
timeFrame: eight weeks
measure: Food Intake changes
timeFrame: Eight weeks
measure: Processed and ultraprocessed food intake changes
timeFrame: Eight weeks
Secondary outcomes:
measure: Rate of Perceived Effort (RPE)
timeFrame: eight weeks
measure: Oxygen saturation (SpO2)
timeFrame: Eight weeks
measure: Internal load (TRIMP)
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of São Paulo, School of Physical Education and Sports of Ribeirão Preto
state: São Paulo
Study officials:
affiliation: USP
name: Marcela C Lima Viliod
role: PRINCIPAL_INVESTIGATOR
References: