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The Effect of Joint Hypermobility Syndrome on Delayed Onset of Muscle Soreness and Recovery Time

Primary Purpose

Hypermobility Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eccentric Exercise for subjects with JHS
Eccentric Exercise for Controls
Sponsored by
New York Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypermobility Syndrome focused on measuring DOMS, Hypermobility,, Recovery

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age range: 18-35 years
  2. Good overall health
  3. Regularly participate in recreational exercise
  4. 10 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)

Exclusion Criteria:

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

Sites / Locations

  • New York Institute of TechnologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

"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.
"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
"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.
"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.
"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.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2021
Last Updated
November 1, 2021
Sponsor
New York Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04934267
Brief Title
The Effect of Joint Hypermobility Syndrome on Delayed Onset of Muscle Soreness and Recovery Time
Official Title
The Effect of Joint Hypermobility Syndrome on Delayed Onset of Muscle Soreness and Recovery Time
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
May 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The research design will be a 2x5 factorial design. 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 (RANG), Pain 1-10 Visual Analogue Scale (VAS), McGill Pain Questionnaire, and pressure pain threshold using an algometer. The proposed study will include 20 participants between the ages of 18-35 years old, who exercise recreationally. Both groups will perform 1 set of standing eccentric bicep curls based on their 1RM to failure in order to induce DOMS.7 Each rep will include a timed 5 second long eccentric component with a metronome and without an concentric component, as the research conductors will lift the weight up or concentrically for the participant. 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. Girth is the measurement of the circumference of a limb measuring swelling, which commonly occurs during DOMS.7 Resting Arm Angle (RANG) is a range of motion (ROM) measurement of the arm while resting.The VAS is a simple pain scale ranging from 0-10, 0 being no pain and 10 being the worst pain the participant has felt..The McGill Pain Questionnaire is a questionnaire that allows the participant to rate their pain'.7 Lastly, the pressure pain threshold using an algometer is done by applying continuous ascending pressure at a constant rate in order to quantify the individuals pain pressure threshold.The change in measurements from baseline to post exercise will be recorded for subsequent data analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypermobility Syndrome
Keywords
DOMS, Hypermobility,, Recovery

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Comparing the recovery times and length of DOMS in individuals with JHS to individuals with normal ranges of motion in response to exercise
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eccentric exercise of elbow in order to induce Delayed Onset of Muscle Soreness
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Eccentric Exercise for subjects with JHS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Eccentric Exercise for Controls
Intervention Description
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.
Primary Outcome Measure Information:
Title
"Change" is being assessed in Girth between the 5 time points
Description
Girth is the measurement of the circumference of a limb in centimetres, measuring edema, which commonly occurs during DOMS.
Time Frame
Baseline (Day 1) through Day 2,3,4 and 5.
Title
"Change' is being assessed in Resting arm angle (RANG)between the 5 time points,
Description
Resting Arm Angle (RANG) is a Range Of Motion measurement in degrees of the arm while resting
Time Frame
Baseline (Day 1) through Day 2,3,4 and 5.
Title
"Change" is being assessed in Visual Analogue Scale (VAS) of Pain between the 5 time points
Description
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.
Time Frame
Baseline (Day 1) through Day 2,3,4 and 5.
Title
"Change" is being assessed in The McGill Pain Questionnaire (SF-MQ2)between the 5 time points
Description
The McGill Pain Questionnaire (SF-MQ2) is a questionnaire that allows the participant to rate their pain.
Time Frame
Baseline (Day 1) through Day 2,3,4 and 5.
Title
"Change" is being assessed in Algometer pain pressure threshold between the 5 time points
Description
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.
Time Frame
Baseline (Day 1) through Day 2,3,4 and 5.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age range: 18-35 years Good overall health Regularly participate in recreational exercise 10 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) Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter C Douris, EdD
Phone
5162486332
Email
pdouris@nyit.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter C Douris, EdD
Organizational Affiliation
New York Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Institute of Technology
City
Old Westbury
State/Province
New York
ZIP/Postal Code
11568
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter C Douris, EdD
Phone
516-248-6332
Email
pdouris@nyit.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan
Citations:
PubMed Identifier
31582002
Citation
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.
Results Reference
background
PubMed Identifier
24107654
Citation
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.
Results Reference
background
PubMed Identifier
22786715
Citation
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.
Results Reference
background
PubMed Identifier
25911504
Citation
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.
Results Reference
background
PubMed Identifier
16875447
Citation
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.
Results Reference
background

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The Effect of Joint Hypermobility Syndrome on Delayed Onset of Muscle Soreness and Recovery Time

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