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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04181671
Other study ID # RiphahIU 00563
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 4, 2019
Est. completion date January 10, 2020

Study information

Verified date January 2020
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 10, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 28 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
Pakistan RCRAHS Potohar campus Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & 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. Epub 2002 Aug 15. — View Citation

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. — View 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. — View Citation

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle strength Handheld dynamometer will be used for measuring muscle strength of bicep muscle of all participants by single examiner Baseline
Primary Muscle strength Handheld dynamometer will be used for measuring muscle strength of bicep muscle of all participants by single examiner Post 6 weeks
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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