NCT04934267

Brief Summary

The purpose of the study is to investigate Joint Hypermobility Syndrome (JHS) and its effect on delayed onset muscle soreness (DOMS) and recovery time. The hypothesis is that people with JHS will experience increased DOMS when compared to non-hypermobile people. The results this study may assist and add to the body of knowledge when treating and exercising patients with JHS, as considerations can possibly be made when treating this population. Subjects with JHS may experience greater DOMS and require more time to recover between treatment sessions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

November 2, 2021

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

May 19, 2021

Last Update Submit

November 1, 2021

Conditions

Keywords

DOMSHypermobility,Recovery

Outcome Measures

Primary Outcomes (5)

  • "Change" is being assessed in Girth between the 5 time points

    Girth is the measurement of the circumference of a limb in centimetres, measuring edema, which commonly occurs during DOMS.

    Baseline (Day 1) through Day 2,3,4 and 5.

  • "Change' is being assessed in Resting arm angle (RANG)between the 5 time points,

    Resting Arm Angle (RANG) is a Range Of Motion measurement in degrees of the arm while resting

    Baseline (Day 1) through Day 2,3,4 and 5.

  • "Change" is being assessed in Visual Analogue Scale (VAS) of Pain between the 5 time points

    The VAS is a simple pain scale ranging from 0-100 mm, 0 being no pain and 100 mm being the worst pain the participant has felt.

    Baseline (Day 1) through Day 2,3,4 and 5.

  • "Change" is being assessed in The McGill Pain Questionnaire (SF-MQ2)between the 5 time points

    The McGill Pain Questionnaire (SF-MQ2) is a questionnaire that allows the participant to rate their pain.

    Baseline (Day 1) through Day 2,3,4 and 5.

  • "Change" is being assessed in Algometer pain pressure threshold between the 5 time points

    the pressure pain threshold using an algometer is done by applying continuous ascending pressure at a constant rate on their self reported most painful area surrounding the elbow in order to quantify the individuals pain pressure threshold, measured in kg.

    Baseline (Day 1) through Day 2,3,4 and 5.

Study Arms (1)

Eccentric exercise of elbow in order to induce Delayed Onset of Muscle Soreness

EXPERIMENTAL

There will be two groups, an experimental group with hypermobile individuals, and a control group with individuals that are not hypermobile with normal ranges of motion. All participants will take part in an exercise session with eccentric bicep curls based on their 1 repetition maximum (1RM).Both groups will perform 1 set of standing eccentric bicep curls based on their 1RM to failure in order to induce DOMS.The exercise will stop when the participant cannot volitionally keep up with the 5 second count lowering the weight. Prior to exercise, baseline measurements will be taken for all dependent variables. These measures will be taken every day at the same time of day,for the next 4 days.

Other: Eccentric Exercise for subjects with JHSOther: Eccentric Exercise for Controls

Interventions

There will be two groups, an experimental group with hypermobile individuals, and a control group with individuals that are not hypermobile with normal ranges of motion. All participants will take part in an exercise session with eccentric bicep curls based on their 1 repetition maximum (1-RM), which is the highest amount of weight that they can lift concentrically once. The independent variables are the two groups and the dependent variables are girth, resting arm angle, Pain, McGill Pain Questionnaire, and pressure pain threshold. This groups will perform 1 set of standing eccentric bicep curls order to induce DOMS.Each rep will include a timed 5 second long eccentric component without an concentric component,. The exercise will stop when the participant cannot volitionally keep up with the 5 second count. Prior to exercise, baseline measurements will be taken for all dependent variables. These measures will be taken every day at the same time of day,for the next 4 days.

Eccentric exercise of elbow in order to induce Delayed Onset of Muscle Soreness

There will be two groups, an experimental group with hypermobile individuals, and a control group with individuals that are not hypermobile with normal ranges of motion. All participants will take part in an exercise session with eccentric bicep curls based on their 1 repetition maximum (1-RM), which is the highest amount of weight that they can lift concentrically once. The independent variables are the two groups and the dependent variables are girth, resting arm angle, Pain, McGill Pain Questionnaire, and pressure pain threshold. This groups will perform 1 set of standing eccentric bicep curls order to induce DOMS.Each rep will include a timed 5 second long eccentric component without an concentric component,. The exercise will stop when the participant cannot volitionally keep up with the 5 second count. Prior to exercise, baseline measurements will be taken for all dependent variables. These measures will be taken every day at the same time of day,for the next 4 days.

Eccentric exercise of elbow in order to induce Delayed Onset of Muscle Soreness

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range: 18-35 years
  • Good overall health
  • Regularly participate in recreational exercise
  • subjects with normal ranges of motion (score of \<4 on Beighton Scale), 10 subjects with increased ranges of motion (score of \>4 on Beighton Scale AND hypermobile in the elbow)

You may not qualify if:

  • Individuals with Ehler-Danlos Syndrome.
  • Any major musculoskeletal injuries in the last 6 months.
  • Any recent traumas that could lead to acute hypermobility or instabilities
  • Any known disorders that impede recovery/healing time (i.e. Lupus, Rheumatoid Arthritis, Scleroderma).
  • Any other health issues that would risk the safety of the subject.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Institute of Technology

Old Westbury, New York, 11568, United States

RECRUITING

Related Publications (5)

  • Tinkle BT, Levy HP. Symptomatic Joint Hypermobility: The Hypermobile Type of Ehlers-Danlos Syndrome and the Hypermobility Spectrum Disorders. Med Clin North Am. 2019 Nov;103(6):1021-1033. doi: 10.1016/j.mcna.2019.08.002.

    PMID: 31582002BACKGROUND
  • Lee H, Petrofsky JS, Laymon M, Yim J. A greater reduction of anterior cruciate ligament elasticity in women compared to men as a result of delayed onset muscle soreness. Tohoku J Exp Med. 2013 Oct;231(2):111-5. doi: 10.1620/tjem.231.111.

    PMID: 24107654BACKGROUND
  • Castori M, Morlino S, Celletti C, Celli M, Morrone A, Colombi M, Camerota F, Grammatico P. Management of pain and fatigue in the joint hypermobility syndrome (a.k.a. Ehlers-Danlos syndrome, hypermobility type): principles and proposal for a multidisciplinary approach. Am J Med Genet A. 2012 Aug;158A(8):2055-70. doi: 10.1002/ajmg.a.35483. Epub 2012 Jul 11.

    PMID: 22786715BACKGROUND
  • Terry RH, Palmer ST, Rimes KA, Clark CJ, Simmonds JV, Horwood JP. Living with joint hypermobility syndrome: patient experiences of diagnosis, referral and self-care. Fam Pract. 2015 Jun;32(3):354-8. doi: 10.1093/fampra/cmv026. Epub 2015 Apr 24.

    PMID: 25911504BACKGROUND
  • Douris P, Southard V, Ferrigi R, Grauer J, Katz D, Nascimento C, Podbielski P. Effect of phototherapy on delayed onset muscle soreness. Photomed Laser Surg. 2006 Jun;24(3):377-82. doi: 10.1089/pho.2006.24.377.

    PMID: 16875447BACKGROUND

Study Officials

  • Peter C Douris, EdD

    New York Institute of Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter C Douris, EdD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Comparing the recovery times and length of DOMS in individuals with JHS to individuals with normal ranges of motion in response to exercise
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 19, 2021

First Posted

June 22, 2021

Study Start

May 1, 2021

Primary Completion

May 1, 2022

Study Completion

May 15, 2022

Last Updated

November 2, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

No plan

Locations