Hypermobility SyndromeNCT04934267
The Effect of Joint Hypermobility Syndrome on Delayed Onset of Muscle Soreness and Recovery Time
A study testing Eccentric Exercise for subjects with JHS in people with Hypermobility Syndrome, run by New York Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypermobility Syndrome
- What is being tested?
- Eccentric Exercise for subjects with JHS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 15 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New York Institute of Technology
Old Westbury, New York, 11568
Peter C Douris, EdD, 516-248-6332, pdouris@nyit.edu
About this study
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.
Read the 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.
- Conditions
- Hypermobility Syndrome
- Being tested
- Eccentric Exercise for subjects with JHS, Eccentric Exercise for Controls
- Keywords
- DOMS, Hypermobility,, Recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric Exercise for subjects with JHSOther
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 for ControlsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Eccentric Exercise for subjects with JHS; Other: Eccentric Exercise for Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1) through Day 2,3,4 and 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 May 2021
- Primary completion1 May 2022 (estimated)
- Study completion15 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hypermobility SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Douris, New York Institute of Technology
- Investigators
- Peter C Douris, EdD, Principal investigator, New York Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934267
- Sponsor's protocol ID
- BHS-1636
- Status last verified
- Nov 2021
- First submitted
- 19 May 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
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.
PubMed 31582002Lee 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.
PubMed 24107654Castori 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.
PubMed 22786715Terry 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.
PubMed 25911504Douris 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.
PubMed 16875447
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Joint Hypermobility Syndrome on Delayed Onset of Muscle Soreness and Recovery Time
- ClinicalTrials.gov ID
- NCT04934267
- Acronym / sponsor ID
- BHS-1636
- Conditions
- Hypermobility Syndrome
- Keywords
- DOMS, Hypermobility,, Recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 15 May 2022 (estimated)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Eccentric exercise of elbow in order to induce Delayed Onset of Muscle Soreness | Experimental | Other: Eccentric Exercise for subjects with JHS, Other: Eccentric Exercise for ControlsThere 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eccentric Exercise for subjects with JHSThere 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. | Other | Eccentric exercise of elbow in order to induce Delayed Onset of Muscle Soreness |
| Eccentric Exercise for ControlsThere 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. | Other | Eccentric exercise of elbow in order to induce Delayed Onset of Muscle Soreness |
Primary outcome
"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.
"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
"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.
"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.
"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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Background: PubMed 31582002Tinkle 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.
- Background: PubMed 24107654Lee 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.
- Background: PubMed 22786715Castori 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.
- Background: PubMed 25911504Terry 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.
- Background: PubMed 16875447Douris 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.
- Individual participant dataSharing planned: No. No plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter C Douris, EdD principal investigator
New York Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric Exercise for subjects with JHS in people with Hypermobility Syndrome, run by New York Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter C Douris, EdD (5162486332, pdouris@nyit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Change" is being assessed in Girth between the 5 time points (time frame: Baseline (Day 1) through Day 2,3,4 and 5.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04934267, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.