Low Resistance Venous Blood Flow Restriction Training (LR-VBFRT) on Biceps Brachii Muscle Performance

January 17, 2020 updated by: Riphah International University

Effects of Low Resistance Venous Blood Flow Restriction Training (LR-VBFRT) on Biceps Brachii Muscle Performance

Resistance training has been widely recognized as an effective stimulus for increasing skeletal muscle size and strength. This study intends to compare the effects of high resistance training without blood flow restriction and the low resistance training with blood flow restriction training on bicep muscle performance.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is Randomized Control Trail, which is being conducted in RIPHAH COLLEGE OF REHABILITATION SCIENCES. Sample size of 40 individual was calculated using Epitool with 95% confidence interval (CI) and power 80%. Individual will be screened out according to inclusion criteria. Individuals will be allocated randomly into two groups, 20 in high resistance training group and 20 in low resistance training with blood flow restriction group by sealed envelope method.

High resistance training will be use in control group.Low resistance with blood flow restriction training will be used in experimental group.

Assessment will be done on baseline 2-4 days prior to the intervention and after 8 weeks of training.

Data will be analyzed on SPSS version 21.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 44000
        • RCRAHS Potohar campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 28 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Males
  • Age: 20-28 year
  • Body mass index: 18.5-24.9

Exclusion Criteria:

  • Vascular Disease
  • Upper Limb Pathology Requiring Surgical Intervention
  • Upper Limb Musculoskeletal Issues
  • Blood Pressure >140/90
  • Coronary Artery Disease
  • Venous Thromboembolism
  • Congenital Cardiac Diseases
  • Syncope, Arrhythmias, Smokers
  • Alcohol Use
  • Supplements Intake
  • whey Protein Intake

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low Resistance Training Group
The experimental group will receive low resistance blood flow restriction training with 30% of 1 RM.
Other: Low Resistance training with venous blood flow restriction

Total 20 males will participate in this group after warmup , Blood flow restriction will be provided through sphygmomanometer optimum pressure will be measured through following formula occlusion pressure (mmHg) = 0.514 (SBP) + 0.339 (DBP) + 1.461 (Arm circumference) + 17.236 then 30% of 1RM will be used for training . The standard protocol will be used which is four sets (1st set-30 repetitions, 2nd set-15 repetitions, 3rd set-15 repetitions, and 4th set-15 repetitions) with 30-60 s of interval between sets. ( the cuff must be deflated between sets of exercise) for 8 weeks (24) sessions on non-consecutive days. participants will be re-assessed for all baseline variables after 8 weeks of training biceps curls will be used for training.

Heart Rate and oxygen saturation will be measured during the session through Pulse oximeter
Active Comparator: High Resistance Training Group
Participants of this group will receive High resistance training (80% of 1 RM) without blood flow restriction.
Other: High Resistance training
Total 20 males will participate in this group after warm up. 80% of 1RM will be used for training, 3 sets of 8 repetitions will be used with 30-60 s of interval between sets. for 8 weeks (24) sessions on non-consecutive days.No blood flow restriction will be applied to this group Participants will be re-assessed for all baseline variables after 8 weeks of training. Bicep curls will be used for training.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: Baseline
Handheld dynamometer will be used for measuring muscle strength of bicep muscle of all participants by single examiner
Baseline
Muscle strength
Time Frame: Post 6 weeks
Handheld dynamometer will be used for measuring muscle strength of bicep muscle of all participants by single examiner
Post 6 weeks
1 Repetition maximum
Time Frame: Baseline
1RM will be assess using Epley's formula of 1RM , RM= w(1+r/30) where "w" is the sub maximal weight and "r" is repetition then percentages of 1RM will be used for training purposes 80% of 1 RM for control group and 30% of 1RM for experimental group.
Baseline
1 Repetition maximum
Time Frame: Post 6 weeks
1RM will be assess using Epley's formula of 1RM , RM= w(1+r/30) where "w" is the sub maximal weight and "r" is repetition then percentages of 1RM will be used for training purposes 80% of 1 RM for control group and 30% of 1RM for experimental group.
Post 6 weeks
Bicep Muscle power
Time Frame: Baseline
Muscle power will be assesses of all the participants using power formula(Power= W/t= FS/t) for that force (F) will be assessed through dynamometer in newton covered distance (S) will be taken as covered range of motion and will be asses through goniometer (elbow flexion in supinated position). Time (t) will be calculated using stop watch
Baseline
Bicep Muscle power
Time Frame: Post 6 weeks
Muscle power will be assesses of all the participants using power formula(Power= W/t= FS/t) for that force (F) will be assessed through dynamometer in newton covered distance (S) will be taken as covered range of motion and will be asses through goniometer (elbow flexion in supinated position). Time (t) will be calculated using stop watch
Post 6 weeks
Bicep muscle endurance testing
Time Frame: Baseline
Bicep muscle endurance will be calculated prior to the intervention by asking participants to lift light -moderate weight and perform bicep curls in supinated position the total number of repetition they will perform doing complete eccentric and concentric movement of the muscle will be taken as the endurance of the bicep muscle
Baseline
Bicep muscle endurance testing
Time Frame: Post 6 weeks
Bicep muscle endurance will be calculated prior to the intervention by asking participants to lift light -moderate weight and perform bicep curls in supinated position the total number of repetition they will perform doing complete eccentric and concentric movement of the muscle will be taken as the endurance of the bicep muscle
Post 6 weeks
Arm circumference
Time Frame: Baseline
arm circumference will be measured in centimeters at the midpoint between the acromion process and the center of the elbow(by measuring tape)
Baseline
Arm circumference
Time Frame: Post 6 weeks
arm circumference will be measured in centimeters at the midpoint between the acromion process and the center of the elbow(by measuring tape)
Post 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RiphahIU 00563

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings