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

• Sponsor: Riphah International University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04181671
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.2
• Patients Per Site Per Month: 18.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Weakness Condition	Other: Low Resistance training with venous blood flow restriction; Other: High Resistance training	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Both experimental and control groups will be treated at the same time following their respective protocolsBoth experimental and control groups will be treated at the same time following their respective protocols
• Masking: Single (Participant)
• Masking Description: This study will be single blinded randomized control trail, participants will be unaware of treatment groups, they will be randomly allocated through sealed envelope method.
• Primary Purpose: Treatment
• Official Title: Effects of Low Resistance Venous Blood Flow Restriction Training (LR-VBFRT) on Biceps Brachii Muscle Performance
• Actual Study Start Date: Nov 4, 2019
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Jan 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Muscle strength [Baseline]

   Handheld dynamometer will be used for measuring muscle strength of bicep muscle of all participants by single examiner

2. Muscle strength [Post 6 weeks]

   Handheld dynamometer will be used for measuring muscle strength of bicep muscle of all participants by single examiner

3. 1 Repetition maximum [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.

4. 1 Repetition maximum [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.

5. Bicep Muscle power [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

6. Bicep Muscle power [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

7. Bicep muscle endurance testing [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

8. Bicep muscle endurance testing [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

9. Arm circumference [Baseline]

   arm circumference will be measured in centimeters at the midpoint between the acromion process and the center of the elbow(by measuring tape)

10. Arm circumference [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 28 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RCRAHS Potohar campus	Rawalpindi	Punjab	Pakistan	44000

Sponsors and Collaborators

• Riphah International University

Investigators

• Principal Investigator: Huma Riaz, PHD*, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

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. Epub 2002 Aug 15.
• Lixandrão 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.
• 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.
• Mattar MA, Gualano B, Perandini LA, Shinjo SK, Lima FR, Sá-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.

• Responsible Party: Riphah International University
• ClinicalTrials.gov Identifier: NCT04181671
• Other Study ID Numbers: RiphahIU 00563
• First Posted: Nov 29, 2019
• Last Update Posted: Jan 22, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Riphah International University: Exercise Training
• Additional relevant MeSH terms: Muscle Weakness

Study Results

No Results Posted as of Jan 22, 2020