- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07444736
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Resistance training has been demonstrated to be an effective intervention for improving muscular strength and metabolic profile. According to the available evidence, a moderate-to-high intensity level (60-90% of one-repetition maximum [1RM]) is required to achieve optimal outcomes in healthy adults.
Blood flow restriction (BFR) training, in turn, has emerged as an innovative strategy that promotes gains comparable or similar to those achieved with moderate-to-high intensity resistance training. It has been proposed as an efficient and safe training alternative in both clinical and non-clinical settings . Current findings identify BFR as a promising, versatile, accessible, and particularly useful tool when moderate-to-high intensity resistance training must be limited or contraindicated.
Therefore, the present study aims to evaluate the effects of 8 weeks of resistance training combined with blood flow restriction on muscular strength, clinical parameters, biochemical biomarkers, and perceived exertion in adults with obesity, providing evidence regarding a potentially safe and effective intervention.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jalisco
-
Tlajomulco de Zúñiga, Jalisco, Mexico, 45650
- Centro Universitario de Tlajomulco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 to 40
- Both genders
- BMI ≥ 30 kg/m^2 and < 40 kg/m^2
- Signed informed consent form
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BFR group
This group will train for 8 weeks
|
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.
The control group will perform quadriceps extensions and biceps curls, completing 4 sets of 10 repetitions at an intensity of 70% of one-repetition maximum (1RM).
The execution tempo will be standardized to 1 second for the concentric phase and 2 seconds for the eccentric phase, with 2-minute inter-set rest intervals.
The protocol will adhere to the resistance training guidelines established by the American College of Sports Medicine (ACSM)
|
|
Active Comparator: Control group
This group will train for 8 weeks
|
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.
The control group will perform quadriceps extensions and biceps curls, completing 4 sets of 10 repetitions at an intensity of 70% of one-repetition maximum (1RM).
The execution tempo will be standardized to 1 second for the concentric phase and 2 seconds for the eccentric phase, with 2-minute inter-set rest intervals.
The protocol will adhere to the resistance training guidelines established by the American College of Sports Medicine (ACSM)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle strength
Time Frame: Baseline and after 8 weeks
|
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
Time Frame: Baseline and after 8 weeks
|
Dynamic muscle strength (kg): Change from baseline to 8 weeks of intervention.
|
Baseline and after 8 weeks
|
|
Arm circumference
Time Frame: Baseline and after 8 weeks
|
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
Time Frame: Baseline and after 8 weeks
|
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)
Time Frame: Baseline and after 8 weeks
|
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)
Time Frame: Baseline and after 8 weeks
|
SBP (mmHg): Changes from baseline to 8 weeks of intervention
|
Baseline and after 8 weeks
|
|
Diastolic blood pressure (DBP)
Time Frame: Baseline and after 8 weeks
|
DBP (mmHg): Changes from baseline to 8 weeks of intervention
|
Baseline and after 8 weeks
|
|
Heart rate
Time Frame: Baseline and after 8 weeks
|
Heart rate (bpm): Change from baseline to 8 weeks of intervention.
|
Baseline and after 8 weeks
|
|
Glucose
Time Frame: Baseline and after 8 weeks
|
Glucose (mg/dl): Changes from baseline to 8 weeks of intervention
|
Baseline and after 8 weeks
|
|
Triglycerides
Time Frame: Baseline and after 8 weeks
|
Triglycerides (mg/dl): Changes from baseline to 8 weeks of intervention
|
Baseline and after 8 weeks
|
|
Total cholesterol
Time Frame: Baseline and after 8 weeks
|
Total cholesterol (mg/dl): Changes from baseline to 8 weeks of intervention
|
Baseline and after 8 weeks
|
|
HDL cholesterol
Time Frame: Baseline and after 8 weeks
|
HDL cholesterol (mg/dl): Changes from baseline to 8 weeks of intervention
|
Baseline and after 8 weeks
|
|
LDL cholesterol
Time Frame: Baseline and after 8 weeks
|
LDL cholesterol (mg/dl): Changes from baseline to 8 weeks of intervention
|
Baseline and after 8 weeks
|
|
C-reactive protein (CRP)
Time Frame: Baseline and after 8 weeks
|
CRP (mg/dl): Changes from baseline to 8 weeks of intervention
|
Baseline and after 8 weeks
|
|
Interleukin-6 (IL-6)
Time Frame: Baseline and after 8 weeks
|
IL-6 (pg/mL):Change from baseline to 8 weeks of intervention.
|
Baseline and after 8 weeks
|
|
Tumor Necrosis Factor Alpha (TNF-α)
Time Frame: Baseline and after 8 weeks
|
TNF-α (pg/mL): Change from baseline to 8 weeks of intervention
|
Baseline and after 8 weeks
|
|
Weight
Time Frame: Baseline and after 8 weeks
|
Weight (kg): Changes in weight from baseline to 8 weeks of intervention.
|
Baseline and after 8 weeks
|
|
Height
Time Frame: Baseline and after 8 weeks
|
Height (cm): Changes in height from baseline to 8 weeks of intervention
|
Baseline and after 8 weeks
|
|
Body mass index (BMI)
Time Frame: Baseline and after 8 weeks
|
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
Time Frame: Baseline and after 8 weeks
|
Body fat percentage (%): Changes in body fat assessed by bioelectrical impedance analysis (BIA)
|
Baseline and after 8 weeks
|
|
Muscle mass percentage
Time Frame: Baseline and after 8 weeks
|
Muscle mass percentage (%): Changes in muscle mass measured using bioelectrical impedance analysis (BIA)
|
Baseline and after 8 weeks
|
|
Perceived Exertion
Time Frame: Baseline and after 8 weeks
|
Perceived exertion will be assessed using the Rating of Perceived Exertion Scale (RPE)
|
Baseline and after 8 weeks
|
|
Exercise enjoyment
Time Frame: Baseline and after 8 weeks
|
Exercise enjoyment will be assessed using the validated Physical Activity Enjoyment Scale Questionnaire (PACES)
|
Baseline and after 8 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CUTLAJO260219
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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