- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04181671
Low Resistance Venous Blood Flow Restriction Training (LR-VBFRT) on Biceps Brachii Muscle Performance
Effects of Low Resistance Venous Blood Flow Restriction Training (LR-VBFRT) on Biceps Brachii Muscle Performance
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Punjab
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Rawalpindi, Punjab, Pakistan, 44000
- RCRAHS Potohar campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low Resistance Training Group
The experimental group will receive low resistance blood flow restriction training with 30% of 1 RM.
|
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
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
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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
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Baseline
|
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Bicep muscle endurance testing
Time Frame: Post 6 weeks
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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
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Post 6 weeks
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Arm circumference
Time Frame: Baseline
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arm circumference will be measured in centimeters at the midpoint between the acromion process and the center of the elbow(by measuring tape)
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Baseline
|
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Arm circumference
Time Frame: Post 6 weeks
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arm circumference will be measured in centimeters at the midpoint between the acromion process and the center of the elbow(by measuring tape)
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Post 6 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Campos GE, Luecke TJ, Wendeln HK, Toma K, Hagerman FC, Murray TF, Ragg KE, Ratamess NA, Kraemer WJ, Staron RS. Muscular adaptations in response to three different resistance-training regimens: specificity of repetition maximum training zones. Eur J Appl Physiol. 2002 Nov;88(1-2):50-60. doi: 10.1007/s00421-002-0681-6. Epub 2002 Aug 15.
- Lixandrao ME, Ugrinowitsch C, Laurentino G, Libardi CA, Aihara AY, Cardoso FN, Tricoli V, Roschel H. Effects of exercise intensity and occlusion pressure after 12 weeks of resistance training with blood-flow restriction. Eur J Appl Physiol. 2015 Dec;115(12):2471-80. doi: 10.1007/s00421-015-3253-2. Epub 2015 Sep 1.
- Mattar MA, Gualano B, Perandini LA, Shinjo SK, Lima FR, Sa-Pinto AL, Roschel H. Safety and possible effects of low-intensity resistance training associated with partial blood flow restriction in polymyositis and dermatomyositis. Arthritis Res Ther. 2014 Oct 25;16(5):473. doi: 10.1186/s13075-014-0473-5.
- Wilson JM, Lowery RP, Joy JM, Loenneke JP, Naimo MA. Practical blood flow restriction training increases acute determinants of hypertrophy without increasing indices of muscle damage. J Strength Cond Res. 2013 Nov;27(11):3068-75. doi: 10.1519/JSC.0b013e31828a1ffa.
- Loenneke JP, Allen KM, Mouser JG, Thiebaud RS, Kim D, Abe T, Bemben MG. Blood flow restriction in the upper and lower limbs is predicted by limb circumference and systolic blood pressure. Eur J Appl Physiol. 2015 Feb;115(2):397-405. doi: 10.1007/s00421-014-3030-7. Epub 2014 Oct 22.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RiphahIU 00563
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
product manufactured in and exported from the U.S.
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