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

Primary Purpose

Muscle Weakness Condition

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Low Resistance training with venous blood flow restriction
High Resistance training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness Condition focused on measuring Exercise Training

Eligibility Criteria

20 Years - 28 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • RCRAHS Potohar campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low Resistance Training Group

High Resistance Training Group

Arm Description

The experimental group will receive low resistance blood flow restriction training with 30% of 1 RM.

Participants of this group will receive High resistance training (80% of 1 RM) without blood flow restriction.

Outcomes

Primary Outcome Measures

Muscle strength
Handheld dynamometer will be used for measuring muscle strength of bicep muscle of all participants by single examiner
Muscle strength
Handheld dynamometer will be used for measuring muscle strength of bicep muscle of all participants by single examiner
1 Repetition maximum
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.
1 Repetition maximum
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.
Bicep Muscle power
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
Bicep Muscle power
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
Bicep muscle endurance testing
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
Bicep muscle endurance testing
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
Arm circumference
arm circumference will be measured in centimeters at the midpoint between the acromion process and the center of the elbow(by measuring tape)
Arm circumference
arm circumference will be measured in centimeters at the midpoint between the acromion process and the center of the elbow(by measuring tape)

Secondary Outcome Measures

Full Information

First Posted
November 26, 2019
Last Updated
January 17, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04181671
Brief Title
Low Resistance Venous Blood Flow Restriction Training (LR-VBFRT) on Biceps Brachii Muscle Performance
Official Title
Effects of Low Resistance Venous Blood Flow Restriction Training (LR-VBFRT) on Biceps Brachii Muscle Performance
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness Condition
Keywords
Exercise Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Both experimental and control groups will be treated at the same time following their respective protocols
Masking
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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Resistance Training Group
Arm Type
Experimental
Arm Description
The experimental group will receive low resistance blood flow restriction training with 30% of 1 RM.
Arm Title
High Resistance Training Group
Arm Type
Active Comparator
Arm Description
Participants of this group will receive High resistance training (80% of 1 RM) without blood flow restriction.
Intervention Type
Other
Intervention Name(s)
Low Resistance training with venous blood flow restriction
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
High Resistance training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle strength
Description
Handheld dynamometer will be used for measuring muscle strength of bicep muscle of all participants by single examiner
Time Frame
Baseline
Title
Muscle strength
Description
Handheld dynamometer will be used for measuring muscle strength of bicep muscle of all participants by single examiner
Time Frame
Post 6 weeks
Title
1 Repetition maximum
Description
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.
Time Frame
Baseline
Title
1 Repetition maximum
Description
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.
Time Frame
Post 6 weeks
Title
Bicep Muscle power
Description
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
Time Frame
Baseline
Title
Bicep Muscle power
Description
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
Time Frame
Post 6 weeks
Title
Bicep muscle endurance testing
Description
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
Time Frame
Baseline
Title
Bicep muscle endurance testing
Description
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
Time Frame
Post 6 weeks
Title
Arm circumference
Description
arm circumference will be measured in centimeters at the midpoint between the acromion process and the center of the elbow(by measuring tape)
Time Frame
Baseline
Title
Arm circumference
Description
arm circumference will be measured in centimeters at the midpoint between the acromion process and the center of the elbow(by measuring tape)
Time Frame
Post 6 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only male participants are recruited in the study.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huma Riaz, PHD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
RCRAHS Potohar campus
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12436270
Citation
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.
Results Reference
background
PubMed Identifier
26323350
Citation
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.
Results Reference
background
PubMed Identifier
25344395
Citation
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.
Results Reference
background
PubMed Identifier
23446173
Citation
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.
Results Reference
background
PubMed Identifier
25338316
Citation
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.
Results Reference
background

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

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