- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04934267
The Effect of Joint Hypermobility Syndrome on Delayed Onset of Muscle Soreness and Recovery Time
November 1, 2021 updated by: Peter Douris, New York Institute of Technology
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Peter C Douris, EdD
- Phone Number: 5162486332
- Email: pdouris@nyit.edu
Study Locations
-
-
New York
-
Old Westbury, New York, United States, 11568
- Recruiting
- New York Institute of Technology
-
Contact:
- Peter C Douris, EdD
- Phone Number: 516-248-6332
- Email: pdouris@nyit.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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 (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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
"Change" is being assessed in Girth between the 5 time points
Time Frame: Baseline (Day 1) through Day 2,3,4 and 5.
|
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,
Time Frame: Baseline (Day 1) through Day 2,3,4 and 5.
|
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
Time Frame: Baseline (Day 1) through Day 2,3,4 and 5.
|
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
Time Frame: Baseline (Day 1) through Day 2,3,4 and 5.
|
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
Time Frame: Baseline (Day 1) through Day 2,3,4 and 5.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2021
Primary Completion (ANTICIPATED)
May 1, 2022
Study Completion (ANTICIPATED)
May 15, 2022
Study Registration Dates
First Submitted
May 19, 2021
First Submitted That Met QC Criteria
June 21, 2021
First Posted (ACTUAL)
June 22, 2021
Study Record Updates
Last Update Posted (ACTUAL)
November 2, 2021
Last Update Submitted That Met QC Criteria
November 1, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BHS-1636
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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