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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • Old Westbury, New York, United States, 11568
        • Recruiting
        • New York Institute of Technology
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Eccentric Exercise for subjects with JHS
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.
Other: Eccentric Exercise for Controls
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New York Institute of Technology

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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