NCT04574661

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2020

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

September 16, 2020

Last Update Submit

February 16, 2021

Conditions

Keywords

Muscle sorenessVital SignsIntermittent occlusionStatic stretching

Outcome Measures

Primary Outcomes (9)

  • 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.

    4th day

  • 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

    4th day

  • 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

    4th day

  • Borg Rate of Perceived Exertion

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

    4th day

  • 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

    4th day

  • Temperature

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

    4th day

  • 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.

    4th day

  • 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.

    4th day

  • Blood pressure

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

    4th day

Study Arms (2)

Static stretching

ACTIVE COMPARATOR

Static stretching to lower limb muscles

Other: Static Stretching

Intermittent occlusion

EXPERIMENTAL

Intermittent occlusion to lower limb

Other: Intermittent Occlusion

Interventions

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.

Static stretching

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

Intermittent occlusion

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalimar Club

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (16)

  • 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.

    PMID: 30399118BACKGROUND
  • 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.

    PMID: 28118308BACKGROUND
  • 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.

    PMID: 22882137BACKGROUND
  • 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.

    PMID: 23977721BACKGROUND
  • 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.

    PMID: 29755363BACKGROUND
  • 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.

    PMID: 18550979BACKGROUND
  • 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.

    PMID: 14604503BACKGROUND
  • 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.

    PMID: 16874584BACKGROUND
  • 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.

    PMID: 26383887BACKGROUND
  • 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.

    PMID: 31135462BACKGROUND
  • 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.

    PMID: 28614163BACKGROUND
  • 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.

    PMID: 22970789BACKGROUND
  • 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.

    PMID: 28153608BACKGROUND
  • 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.

    PMID: 16476913BACKGROUND
  • 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.

    PMID: 12617692BACKGROUND
  • 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.

    PMID: 28742609BACKGROUND

MeSH Terms

Conditions

Myalgia

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Anam Aftab, Phd*

    Riphah college of rehabilitation and allied health sciences - Rawalpindi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2020

First Posted

October 5, 2020

Study Start

January 15, 2020

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

February 17, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations