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CompletedNCT04574661Updated Feb 17, 2021

Comparison of Intermittent Occlusion and Static Stretching

An interventional study of Static Stretching and Intermittent Occlusion in Muscle Soreness, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-17.

Sponsored by Riphah International University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jan 2020, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Muscle Soreness

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Keywords

  • Muscle soreness
  • Vital Signs
  • Intermittent occlusion
  • Static stretching
03

In context

Myalgia

282 studies on the registry are indexed under Myalgia; 43 are open to participants now.

This study's enrollment of 20 is below the median of 44 across 241 interventional studies indexed under Myalgia.

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Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Static stretching

    Static stretching to lower limb muscles

    Other: Static Stretching

  • Experimental
    Intermittent occlusion

    Intermittent occlusion to lower limb

    Other: Intermittent Occlusion

Interventions

  • OtherStatic Stretching

    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.

  • OtherIntermittent Occlusion

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4th day

  2. 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

    Time frame: 4th day

  3. 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

    Time frame: 4th day

  4. Borg Rate of Perceived Exertion

    Research suggest that the Borg CR-10 scale is valid and reliable for monitoring exercise intensity

    Time frame: 4th day

  5. 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

    Time frame: 4th day

  6. Temperature

    A valid Tool for temperature measurement which has been in use from centuries is Mercury Thermometer.

    Time frame: 4th day

  7. 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.

    Time frame: 4th day

  8. 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.

    Time frame: 4th day

  9. Blood pressure

    The aneroid monitor is valid and cost effective tool which for measuring blood pressure

    Time frame: 4th day

07

Study locations

1 site
  • Shalimar Club
    Rawalpindi, Punjab 46000, Pakistan
08

References and documents

Publications

  • 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. PubMed 30399118 ↗
  • 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. PubMed 28118308 ↗
  • 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. PubMed 22882137 ↗
  • 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. PubMed 23977721 ↗
  • 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. PubMed 29755363 ↗
  • 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. PubMed 18550979 ↗
  • 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. PubMed 14604503 ↗
  • 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. PubMed 16874584 ↗
  • 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. PubMed 26383887 ↗
  • 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. PubMed 31135462 ↗
  • 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. PubMed 28614163 ↗
  • 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. PubMed 22970789 ↗
  • 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. PubMed 28153608 ↗
  • 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. PubMed 16476913 ↗
  • 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. PubMed 12617692 ↗
  • 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. PubMed 28742609 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04574661
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Oct 5, 2020
Start date
Jan 15, 2020
Primary completion
Sep 30, 2020
Completion
Sep 30, 2020
Last update
Feb 17, 2021

Study contacts

Anam Aftab, Phd*
principal investigator · Riphah college of rehabilitation and allied health sciences - Rawalpindi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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