NCT05380830

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2022

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

May 15, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

May 7, 2022

Last Update Submit

May 12, 2023

Conditions

Obesity

Keywords

ObesityIntermittent hypoxiaMetabolic diseaseDeep-water running

Outcome Measures

Primary Outcomes (12)

  • Body weight changes (Anthropometry)

    Changes in body weight (kilograms - Kg) pre- and post- intervention.

    Eight weeks

  • Height assessment (Anthropometry)

    Height measured in meters

    Eight weeks

  • Body mass index changes (Anthropometry)

    Changes in body mass index (BMI = weight measured(kg) / (height (m)²) evaluated pre- and post- intervention.

    Eight weeks

  • Body composition changes (Anthropometry)

    Changes in fat-free mass, fat mass and bone mineral content evaluated pre- and post- intervention. Dual energy x-ray absorptiometry (DEXA) will be use.

    Eight weeks

  • Erythrogram (Hematological profile)

    The red cells, hematocrit cells and hemoglobin will be evaluated pré- and post- intervention using a Radiometer-ABL 700 (Radiometer, Copenhagen, Denmark), and for erythropoietin evaluation an EPO Immunoassay ELISA kit will be used.

    Eight weeks

  • EPO (Hematological profile)

    The erythropoietin will be evaluated with an EPO Immunoassay ELISA kit in pre- and post- intervention .

    Eight weeks

  • Lipid profile

    Changes in total cholesterol, triglycerides, HDL-cholesterol and LDL-cholesterol and blood glucose evaluated pre- and post- intervention, quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer.

    Eight weeks

  • Inflammatory profile

    Changes in serum levels of cytokines IL-6, TNF-α, adiponectin, FBP4 and leptin will be evaluated pre- and post- intervention, by MILLIPLEX® Kit.

    Eight weeks

  • Changes in aerobic performance (deep-water running)

    Physical tests performed pre-, after 4 weeks and post- intervention to assess aerobic physical fitness by incremental test in treadmill. The test aim to evaluate the anaerobic threshold (AT) and VO2peak in deep-water running.

    eight weeks

  • Changes in aerobic performance (treadmill)

    Physical tests performed pre-, after 4 weeks and post- intervention to assess aerobic physical fitness by incremental test in treadmill. The test aim to evaluate the anaerobic threshold (AT) and VO2peak in treadmill.

    eight weeks

  • Food Intake changes

    A food record of three non-consecutive days: two days of the week and one day in the weekend. This evaluation will last eight weeks. The caloric intake, macronutrients and fiber will be evaluated over the intervention with Dietwin® software (São Paulo, Brazil).

    Eight weeks

  • Processed and ultraprocessed food intake changes

    The feed will undergo analysis through the NOVA Classification. By NOVA, food will be classified into four groups: Group 1 - Unprocessed or minimally processed foods; Group 2 - Processed culinary ingredients; Group 3 - Processed foods; Group 4 - Ultra-processed foods. For each category, the total calories ingested will be calculated, and later, represented in percentage (%) the participation of each food group in the general diet.

    Eight weeks

Secondary Outcomes (3)

  • Rate of Perceived Effort (RPE)

    eight weeks

  • Oxygen saturation (SpO2)

    Eight weeks

  • Internal load (TRIMP)

    Eight weeks

Study Arms (3)

Control

NO INTERVENTION

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 Hypoxia

EXPERIMENTAL

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%).

Other: Tied deep-Water Running

Group Normoxia

PLACEBO COMPARATOR

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%).

Other: Tied deep-Water Running

Interventions

Tied deep-Water RunningOTHER

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.

Also known as: DWR
Group HypoxiaGroup Normoxia

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

MeSH Terms

Conditions

ObesityMetabolic Diseases

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marcela C Lima Viliod

    USP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be randomly distributed into 3 groups: Control (Gcon), Hypoxia (GHyp) and Normoxia (GNor). Those in Ghyp and GNor won't be able to know which group they are.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2022

First Posted

May 19, 2022

Study Start

March 1, 2022

Primary Completion

May 10, 2022

Study Completion

August 1, 2022

Last Updated

May 15, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)