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Comparison of Intermittent Occlusion and Static Stretching

Primary Purpose

Muscle Soreness

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Static Stretching
Intermittent Occlusion
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Muscle Soreness focused on measuring Muscle soreness, Vital Signs, Intermittent occlusion, Static stretching

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age limit: 18 -25 years of age.
  • Both Males and Females.
  • Participants intending to join a fitness or body building program shortly ( the first exercise session would be utilized to induce mild muscle soreness )
  • Participants ready for physical exertion according to PAR-Q.

Exclusion Criteria:

  • Obesity (body mass index ≥ 30 kg/m2).
  • Skeletal or Orthopedic Injuries.
  • Known Cardiovascular disease.
  • Open wounds.
  • Uncontrolled Hypertension (resting brachial blood pressure ≥ 140/90 mmHg).
  • Exercise induced muscle soreness in last 6 months.

Sites / Locations

  • Shalimar Club

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Static stretching

Intermittent occlusion

Arm Description

Static stretching to lower limb muscles

Intermittent occlusion to lower limb

Outcomes

Primary Outcome Measures

Numeric pain rating scale (NPRS)
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). It has been shown that a composite scoring system including best, worse, and current level of pain. 27 Recent studies showed that the Majority of patients of all ages and both genders prefer NRS 28. Patients feel this scale of pain measuring technique quite easy and understandable. The benefit of the NRS is that it is validated as well as quick and easy to use.
Goniometer
A goniometer is an instrument which measures the available range of motion at a joint. This can be an indicator of stress which is unavoidable. Many studies showed that The universal goniometer are reliable in repeated measures of joint angles 30 .Manual goniometers can be used with confidence for longitudinal assessments in the clinic
Measuring Tape
Tape measurement has been used for decades round measurement or the contour of the Muscle to detect atrophy or hypertrophy of Joint to determine swelling. Research shows that measuring tape is valid and reliable tool for circumference measurements .Circumference measurements taken by spring tape have high reliability
Borg Rate of Perceived Exertion
Research suggest that the Borg CR-10 scale is valid and reliable for monitoring exercise intensity
PAR-Q Questionnaire
Physical Activity Readiness Questionnaire (PARQ) clearance has been recommended prior to low-to-moderate exercise involvement. Physical Activity Readiness Questionnaire (PARQ) is safe and effective means of risk stratification for patients interested in becoming more physically active. These results support the concurrent validity of the PARQ and suggest the revisions have had their intended effect
Temperature
A valid Tool for temperature measurement which has been in use from centuries is Mercury Thermometer.
Pulse rate
The pulse rate is a measurement of the heart rate, or the number of times the heart beats per minute which can be felt by the beats by firmly pressing on the arteries, which are located close to the surface of the skin at certain points of the body. In this study we will be using Radial Artery.
Respiratory Rate
The respiration rate is the number of breaths a person takes per minute , when a person is at rest counting the number of breaths for one minute by counting how many times the chest rises.
Blood pressure
The aneroid monitor is valid and cost effective tool which for measuring blood pressure

Secondary Outcome Measures

Full Information

First Posted
September 16, 2020
Last Updated
February 16, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04574661
Brief Title
Comparison of Intermittent Occlusion and Static Stretching
Official Title
Comparison of Intermittent Occlusion and Static Stretching of Muscles in Prevention of Soreness and Vital Changes in Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 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
No

5. Study Description

Brief Summary
To determine changes in Vitals caused by Intermittent Occlusion ( 220 mg ) and to compare the effectiveness of Intermittent Occlusion and Static Stretching of the lower limb muscle group in preventing the development of exercise induce Muscle Soreness
Detailed Description
Main purpose of this study is to determine changes in Vitals caused by Intermittent Occlusion ( 220 mg ) and to compare the effectiveness of Intermittent Occlusion and Static Stretching of the lower limb muscle group in preventing the development of exercise induce Muscle Soreness. As muscle soreness is very major and basis problem of every individual , specially after enrolling into some physical activity . First consent form will be given to both male and female participants from 18 to 25 years of age and after that PAR-Q Questionnaire will be filled for every individual, so that we will check their readiness for the Exercise then all the four Vitals will measured from every individual .They will randomly assigned by lottery method to intervention group and control group. Both group individuals will be exerted by Warm up for 5 mints, heel raise in 3 sets for 10 to 15 mints until we get 4 on RPE scale, by asking to hold dumbbells of 2 kg on both of the hands. Rate of perceived exertion (RPE) is calculated by Borg grading scale .Plus, leg circumference, ROM of planter and dorsal flexion and numeric pain rating scale (NPRS) will be measured for comparison within and between the groups. Again vitals will be monitored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Soreness
Keywords
Muscle soreness, Vital Signs, Intermittent occlusion, Static stretching

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Static stretching
Arm Type
Active Comparator
Arm Description
Static stretching to lower limb muscles
Arm Title
Intermittent occlusion
Arm Type
Experimental
Arm Description
Intermittent occlusion to lower limb
Intervention Type
Other
Intervention Name(s)
Static Stretching
Intervention Description
In Control group all the individuals will be asked to perform static stretching for 10 mints, 1 set . Vitals will be monitored from every individual. On 3rd day to this protocol leg circumference, ROM of planter and dorsal flexion and numeric pain rating scale (NPRS ) will be measured alone with all the Vitals from every individual.
Intervention Type
Other
Intervention Name(s)
Intermittent Occlusion
Intervention Description
Individuals of Interventional group will be asked to lay down in supine position, apply proximal thigh cuff, 220mg for 12 minutes for intermittent occlusion. During this procedure discomfort will be checked on numeric pain rating scale, if we get 6 on scale, will stop the occlusion. Vitals will be monitored from every individual. On 3rd day to this protocol leg circumference, ROM of planter and dorsal flexion and numeric pain rating scale (NPRS ) will be measured alone with all the Vitals from every individual
Primary Outcome Measure Information:
Title
Numeric pain rating scale (NPRS)
Description
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). It has been shown that a composite scoring system including best, worse, and current level of pain. 27 Recent studies showed that the Majority of patients of all ages and both genders prefer NRS 28. Patients feel this scale of pain measuring technique quite easy and understandable. The benefit of the NRS is that it is validated as well as quick and easy to use.
Time Frame
4th day
Title
Goniometer
Description
A goniometer is an instrument which measures the available range of motion at a joint. This can be an indicator of stress which is unavoidable. Many studies showed that The universal goniometer are reliable in repeated measures of joint angles 30 .Manual goniometers can be used with confidence for longitudinal assessments in the clinic
Time Frame
4th day
Title
Measuring Tape
Description
Tape measurement has been used for decades round measurement or the contour of the Muscle to detect atrophy or hypertrophy of Joint to determine swelling. Research shows that measuring tape is valid and reliable tool for circumference measurements .Circumference measurements taken by spring tape have high reliability
Time Frame
4th day
Title
Borg Rate of Perceived Exertion
Description
Research suggest that the Borg CR-10 scale is valid and reliable for monitoring exercise intensity
Time Frame
4th day
Title
PAR-Q Questionnaire
Description
Physical Activity Readiness Questionnaire (PARQ) clearance has been recommended prior to low-to-moderate exercise involvement. Physical Activity Readiness Questionnaire (PARQ) is safe and effective means of risk stratification for patients interested in becoming more physically active. These results support the concurrent validity of the PARQ and suggest the revisions have had their intended effect
Time Frame
4th day
Title
Temperature
Description
A valid Tool for temperature measurement which has been in use from centuries is Mercury Thermometer.
Time Frame
4th day
Title
Pulse rate
Description
The pulse rate is a measurement of the heart rate, or the number of times the heart beats per minute which can be felt by the beats by firmly pressing on the arteries, which are located close to the surface of the skin at certain points of the body. In this study we will be using Radial Artery.
Time Frame
4th day
Title
Respiratory Rate
Description
The respiration rate is the number of breaths a person takes per minute , when a person is at rest counting the number of breaths for one minute by counting how many times the chest rises.
Time Frame
4th day
Title
Blood pressure
Description
The aneroid monitor is valid and cost effective tool which for measuring blood pressure
Time Frame
4th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age limit: 18 -25 years of age. Both Males and Females. Participants intending to join a fitness or body building program shortly ( the first exercise session would be utilized to induce mild muscle soreness ) Participants ready for physical exertion according to PAR-Q. Exclusion Criteria: Obesity (body mass index ≥ 30 kg/m2). Skeletal or Orthopedic Injuries. Known Cardiovascular disease. Open wounds. Uncontrolled Hypertension (resting brachial blood pressure ≥ 140/90 mmHg). Exercise induced muscle soreness in last 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anam Aftab, Phd*
Organizational Affiliation
Riphah college of rehabilitation and allied health sciences - Rawalpindi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shalimar Club
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30399118
Citation
Magoffin RD, Parcell AC, Hyldahl RD, Fellingham GW, Hopkins JT, Feland JB. Whole-Body Vibration as a Warm-up Before Exercise-Induced Muscle Damage on Symptoms of Delayed-Onset Muscle Soreness in Trained Subjects. J Strength Cond Res. 2020 Apr;34(4):1123-1132. doi: 10.1519/JSC.0000000000002896.
Results Reference
background
PubMed Identifier
28118308
Citation
Brandner CR, Warmington SA. Delayed Onset Muscle Soreness and Perceived Exertion After Blood Flow Restriction Exercise. J Strength Cond Res. 2017 Nov;31(11):3101-3108. doi: 10.1519/JSC.0000000000001779.
Results Reference
background
PubMed Identifier
22882137
Citation
Hedayatpour N, Arendt-Nielsen L, Falla D. Facilitation of quadriceps activation is impaired following eccentric exercise. Scand J Med Sci Sports. 2014 Apr;24(2):355-62. doi: 10.1111/j.1600-0838.2012.01512.x. Epub 2012 Aug 12.
Results Reference
background
PubMed Identifier
23977721
Citation
Kanda K, Sugama K, Hayashida H, Sakuma J, Kawakami Y, Miura S, Yoshioka H, Mori Y, Suzuki K. Eccentric exercise-induced delayed-onset muscle soreness and changes in markers of muscle damage and inflammation. Exerc Immunol Rev. 2013;19:72-85.
Results Reference
background
PubMed Identifier
29755363
Citation
Dupuy O, Douzi W, Theurot D, Bosquet L, Dugue B. An Evidence-Based Approach for Choosing Post-exercise Recovery Techniques to Reduce Markers of Muscle Damage, Soreness, Fatigue, and Inflammation: A Systematic Review With Meta-Analysis. Front Physiol. 2018 Apr 26;9:403. doi: 10.3389/fphys.2018.00403. eCollection 2018.
Results Reference
background
PubMed Identifier
18550979
Citation
Newton MJ, Morgan GT, Sacco P, Chapman DW, Nosaka K. Comparison of responses to strenuous eccentric exercise of the elbow flexors between resistance-trained and untrained men. J Strength Cond Res. 2008 Mar;22(2):597-607. doi: 10.1519/JSC.0b013e3181660003.
Results Reference
background
PubMed Identifier
14604503
Citation
Graven-Nielsen T, Arendt-Nielsen L. Induction and assessment of muscle pain, referred pain, and muscular hyperalgesia. Curr Pain Headache Rep. 2003 Dec;7(6):443-51. doi: 10.1007/s11916-003-0060-y.
Results Reference
background
PubMed Identifier
16874584
Citation
Chapman D, Newton M, Sacco P, Nosaka K. Greater muscle damage induced by fast versus slow velocity eccentric exercise. Int J Sports Med. 2006 Aug;27(8):591-8. doi: 10.1055/s-2005-865920.
Results Reference
background
PubMed Identifier
26383887
Citation
Costello JT, Baker PR, Minett GM, Bieuzen F, Stewart IB, Bleakley C. Whole-body cryotherapy (extreme cold air exposure) for preventing and treating muscle soreness after exercise in adults. Cochrane Database Syst Rev. 2015 Sep 18;2015(9):CD010789. doi: 10.1002/14651858.CD010789.pub2.
Results Reference
background
PubMed Identifier
31135462
Citation
Luetmer MT, Do A, Canzanello NC, Bauer BA, Laskowski ER. The Feasibility and Effects of Acupuncture on Muscle Soreness and Sense of Well-being in an Adolescent Football Population. Am J Phys Med Rehabil. 2019 Nov;98(11):964-970. doi: 10.1097/PHM.0000000000001226.
Results Reference
background
PubMed Identifier
28614163
Citation
Farias Junior LF, Browne RAV, Frazao DT, Dantas TCB, Silva PHM, Freitas RPA, Aoki MS, Costa EC. Effect of Low-Volume High-Intensity Interval Exercise and Continuous Exercise on Delayed-Onset Muscle Soreness in Untrained Healthy Males. J Strength Cond Res. 2019 Mar;33(3):774-782. doi: 10.1519/JSC.0000000000002059.
Results Reference
background
PubMed Identifier
22970789
Citation
Beaven CM, Cook CJ, Kilduff L, Drawer S, Gill N. Intermittent lower-limb occlusion enhances recovery after strenuous exercise. Appl Physiol Nutr Metab. 2012 Dec;37(6):1132-9. doi: 10.1139/h2012-101. Epub 2012 Sep 12.
Results Reference
background
PubMed Identifier
28153608
Citation
Page W, Swan R, Patterson SD. The effect of intermittent lower limb occlusion on recovery following exercise-induced muscle damage: A randomized controlled trial. J Sci Med Sport. 2017 Aug;20(8):729-733. doi: 10.1016/j.jsams.2016.11.015. Epub 2017 Jan 24.
Results Reference
background
PubMed Identifier
16476913
Citation
LaRoche DP, Connolly DA. Effects of stretching on passive muscle tension and response to eccentric exercise. Am J Sports Med. 2006 Jun;34(6):1000-7. doi: 10.1177/0363546505284238. Epub 2006 Feb 13.
Results Reference
background
PubMed Identifier
12617692
Citation
Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. doi: 10.2165/00007256-200333020-00005.
Results Reference
background
PubMed Identifier
28742609
Citation
Xie Y, Feng B, Chen K, Andersen LL, Page P, Wang Y. The Efficacy of Dynamic Contract-Relax Stretching on Delayed-Onset Muscle Soreness Among Healthy Individuals: A Randomized Clinical Trial. Clin J Sport Med. 2018 Jan;28(1):28-36. doi: 10.1097/JSM.0000000000000442.
Results Reference
background

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Comparison of Intermittent Occlusion and Static Stretching

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