NCT07444736

Brief Summary

To analyze the effect of 8 weeks of resistance training with blood flow restriction on muscle strength, clinical parameters, biochemical biomarkers, and perceived exertion in adults with obesity.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

February 1, 2026

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

1 month

First QC Date

February 25, 2026

Last Update Submit

February 25, 2026

Conditions

Keywords

ObesityExercise

Outcome Measures

Primary Outcomes (23)

  • Muscle strength

    Muscle strength (kg): Change from baseline to 8 weeks of intervention. Muscle strength will be assessed using dynamometry

    Baseline and after 8 weeks

  • Dynamic muscle strength

    Dynamic muscle strength (kg): Change from baseline to 8 weeks of intervention.

    Baseline and after 8 weeks

  • Arm circumference

    Arm circumference (cm): Change from baseline to 8 weeks of intervention. Measurements will be obtained using a non-elastic measuring tape in accordance with the International Society for the Advancement of Kinanthropometry (ISAK) protocol

    Baseline and after 8 weeks

  • Thigh circumference

    Thigh circumference (cm): Change from baseline to 8 weeks of intervention. Measurements will be obtained using a non-elastic measuring tape in accordance with the International Society for the Advancement of Kinanthropometry (ISAK) protocol

    Baseline and after 8 weeks

  • Maximum oxygen uptake (VO₂max)

    VO₂max (ml/min/kg): Change from Baseline at 8 weeks, measured using a submaximal exercise test based on the Åstrand-Ryhming protocol

    Baseline and after 8 weeks

  • Systolic blood pressure (SBP)

    SBP (mmHg): Changes from baseline to 8 weeks of intervention

    Baseline and after 8 weeks

  • Diastolic blood pressure (DBP)

    DBP (mmHg): Changes from baseline to 8 weeks of intervention

    Baseline and after 8 weeks

  • Heart rate

    Heart rate (bpm): Change from baseline to 8 weeks of intervention.

    Baseline and after 8 weeks

  • Glucose

    Glucose (mg/dl): Changes from baseline to 8 weeks of intervention

    Baseline and after 8 weeks

  • Triglycerides

    Triglycerides (mg/dl): Changes from baseline to 8 weeks of intervention

    Baseline and after 8 weeks

  • Total cholesterol

    Total cholesterol (mg/dl): Changes from baseline to 8 weeks of intervention

    Baseline and after 8 weeks

  • HDL cholesterol

    HDL cholesterol (mg/dl): Changes from baseline to 8 weeks of intervention

    Baseline and after 8 weeks

  • LDL cholesterol

    LDL cholesterol (mg/dl): Changes from baseline to 8 weeks of intervention

    Baseline and after 8 weeks

  • C-reactive protein (CRP)

    CRP (mg/dl): Changes from baseline to 8 weeks of intervention

    Baseline and after 8 weeks

  • Interleukin-6 (IL-6)

    IL-6 (pg/mL):Change from baseline to 8 weeks of intervention.

    Baseline and after 8 weeks

  • Tumor Necrosis Factor Alpha (TNF-α)

    TNF-α (pg/mL): Change from baseline to 8 weeks of intervention

    Baseline and after 8 weeks

  • Weight

    Weight (kg): Changes in weight from baseline to 8 weeks of intervention.

    Baseline and after 8 weeks

  • Height

    Height (cm): Changes in height from baseline to 8 weeks of intervention

    Baseline and after 8 weeks

  • Body mass index (BMI)

    BMI (kg/m\^2): Change from Baseline at 8 weeks, calculated by: weight (kg)/ height (m\^2).

    Baseline and after 8 weeks

  • Body fat percentage

    Body fat percentage (%): Changes in body fat assessed by bioelectrical impedance analysis (BIA)

    Baseline and after 8 weeks

  • Muscle mass percentage

    Muscle mass percentage (%): Changes in muscle mass measured using bioelectrical impedance analysis (BIA)

    Baseline and after 8 weeks

  • Perceived Exertion

    Perceived exertion will be assessed using the Rating of Perceived Exertion Scale (RPE)

    Baseline and after 8 weeks

  • Exercise enjoyment

    Exercise enjoyment will be assessed using the validated Physical Activity Enjoyment Scale Questionnaire (PACES)

    Baseline and after 8 weeks

Study Arms (2)

BFR group

EXPERIMENTAL

This group will train for 8 weeks

Other: Intervention

Control group

ACTIVE COMPARATOR

This group will train for 8 weeks

Other: Intervention

Interventions

The BFR group will perform machine-based quadriceps extension exercises and dumbbell biceps curls involving both lower limbs and both upper limbs. Each exercise will consist of 4 sets of 12 repetitions. Quadriceps extensions will be performed at an intensity of 40% of one-repetition maximum (1RM), and biceps curls at 20% of 1RM. The execution cadence will be standardized to 1 second for the concentric phase and 2 seconds for the eccentric phase. Inter-set rest intervals will be 1 minute. For vascular occlusion, a Carbafix cuff (8 cm width × 68 cm length for the upper limb; 10.5 cm width × 106.0 cm length for the lower limb) will be applied directly to the skin at the most proximal portion of the arm or thigh. The cuff will be inflated to 20 mmHg above resting brachial systolic blood pressure. To ensure partial vascular occlusion, pulse and oxygen saturation will be assessed using a pulse oximeter at the end of each set. Cuff pressure will be released during the inter-set rest periods.

BFR group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18 to 40
  • Both genders
  • BMI ≥ 30 kg/m\^2 and \< 40 kg/m\^2
  • Signed informed consent form

You may not qualify if:

  • Participants who smoke
  • Personal and family history of vascular disease or deep vein thrombosis
  • Clinical diagnosis of hypothyroidism
  • Clinical diagnosis of type 1 diabetes mellitus
  • Clinical diagnosis of type 2 diabetes mellitus
  • Clinical diagnosis of grade 3 obesity
  • Clinical diagnosis of hypertension
  • Clinical diagnosis of acute myocardial infarction or angina pectoris
  • Use of nitrates and calcium channel blockers within 4 days prior to the start of the study
  • Use of anticoagulants
  • Use of beta-blockers or hypoglycemic agents within 7 days prior to the intervention
  • Pregnant women
  • Breastfeeding women
  • Men consuming more than 40 g of alcohol per day or women consuming more than 20 g per day
  • Postural and biomechanical disorders (knee, foot, and spine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Universitario de Tlajomulco

Tlajomulco de Zúñiga, Jalisco, 45650, Mexico

Location

MeSH Terms

Conditions

ObesityOverweightMotor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 3, 2026

Study Start

February 1, 2026

Primary Completion

March 15, 2026

Study Completion

May 15, 2026

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations