NCT04181671

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2019

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

November 26, 2019

Last Update Submit

January 17, 2020

Conditions

Keywords

Exercise Training

Outcome Measures

Primary Outcomes (10)

  • Muscle strength

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

    Baseline

  • Muscle strength

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

    Post 6 weeks

  • 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.

    Baseline

  • 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.

    Post 6 weeks

  • 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

    Baseline

  • 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

    Post 6 weeks

  • 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

    Baseline

  • 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

    Post 6 weeks

  • 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)

    Baseline

  • 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)

    Post 6 weeks

Study Arms (2)

Low Resistance Training Group

EXPERIMENTAL

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

High Resistance Training Group

ACTIVE COMPARATOR

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

Other: High Resistance training

Interventions

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

Low Resistance Training Group

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.

High Resistance Training Group

Eligibility Criteria

Age20 Years - 28 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly male participants are recruited in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RCRAHS Potohar campus

Rawalpindi, Punjab Province, 44000, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 12436270BACKGROUND
  • 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.

    PMID: 26323350BACKGROUND
  • 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.

    PMID: 25344395BACKGROUND
  • 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.

    PMID: 23446173BACKGROUND
  • 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.

    PMID: 25338316BACKGROUND

Study Officials

  • Huma Riaz, PHD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Both experimental and control groups will be treated at the same time following their respective protocols
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2019

First Posted

November 29, 2019

Study Start

November 4, 2019

Primary Completion

January 1, 2020

Study Completion

January 10, 2020

Last Updated

January 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations