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Presentation of Young Adults With and Without Joint Hypermobility

2026年6月17日 更新者:Leslie Russek、Clarkson University

Prospective Study of Symptoms in People With and Without Joint Hypermobility

People with multiple hypermobile joints are diagnosed with Generalized Joint Hypermobility (GJH) when asymptomatic, or Hypermobile Ehlers-Danlos Syndrome (hEDS) and Hypermobility Spectrum Disorder (HSD) when symptomatic (hEDS/HSD, or 'HSD' here). GJH likely affects about 20% of the U.S. population, while HSD affects 0.5-3% of the US population. Although joint hypermobility is the most visible presentation of HSD, it is a systemic connective tissue disorder affecting multiple body systems. Due to frequent health concerns, HSD may contribute to more than 30% of patients in chronic pain, rheumatology, orthopedic and physical therapy clinics. It is still unclear why some people have asymptomatic hypermobility and others develop complex chronic health issues. However, recent research suggests that the transition might be triggered by severe physiological stress, such as viral infection.

HSD is commonly associated with Postural Orthostatic Tachycardia Syndrome (POTS) and Mast Cell Activation Syndrome (MCAS), as well as gastrointestinal (GI) problems. Recent research suggests that persistent inflammation due to MCAS or COVID may trigger HSD symptoms. The correlation between POTS and HSD may be due to effects of HSD on the autonomic nervous system or to inflammation triggering both conditions. It is also unclear whether body awareness and coordination deficits seen in symptomatic HSD are due to the fundamental connective tissue disorder or due to pain and injuries in HSD. This study seeks to determine whether asymptomatic hypermobile individuals (GJH) also have balance and coordination deficits. The current study hopes to identify factors that correlate with a transition from asymptomatic GJH to symptomatic HSD by following a group of Health Science students forward in time. The study will collect baseline health information including relevant diagnoses, symptoms and function. Physical measurements will include standard clinical tests performed by physical therapists: joint hypermobility and instability, standing balance, neck movement control, and heart rate in response to standing from lying down. The study is likely to last for at least 10 years to follow participants over time.

調査の概要

詳細な説明

Most hyper mobility-related research is conducted by clinical researchers, who are generally limited to recruiting research subjects from patients who present to their clinics. There are few opportunities for longitudinal studies of asymptomatic or 'healthy' individuals to identify potential triggers prospectively and to compare to people who do not develop symptoms. A health care academic institution provides the ideal environment for a prospective study, somewhat like the 'Nurses Health Study'* that followed a population of nurses throughout their lives.

The study will collect initial data on:

  • Current diagnoses related to HSD, MCAS, and POTS (questionnaire)
  • Current symptoms associated with HSD, MCAS and POTS (questionnaire)
  • Overall quality of life (questionnaire)
  • Physical measures for diagnosing joint hypermobility and instability
  • Physical screening for POTS
  • Physical screening for body awareness, balance and coordination

Objectives and Hypotheses

  1. What is the prevalence of HSD, POTS and MCAS in a 'healthy' young adult population?
  2. How often are HSD, POTS and MCAS undiagnosed in a 'healthy' young adult population?
  3. Are there factors that trigger or precede the development of widespread symptoms in people who have GJH, causing them to develop HSD?
  4. What risk factors are associated with increased likelihood that an individual will develop POTS, MCAS, or HSD?
  5. Do balance or motor control in the neck differ in asymptomatic joint hypermobility compared to symptomatic hypermobility?
  6. If coordination impairments exist in asymptomatic people with hypermobility, does that predict development of HSD?

Questionnaires will be on secure Google Forms accessed through participants' phones or other electronic devices. Participants may pause and return to the questionnaires if they choose. We intend for the questionnaires to require no more than 30 minutes to complete; we may need to eliminate questions from the current list to achieve this.

Physical measurements will be performed only at the initial data collection. These measurements will be performed by licensed physical therapists, who may be assisted by physical therapy graduate students with adequate training to assist in selected data collection. Data collection will take place in Clarkson Hall. Measurements are likely to be performed at 'stations' by various assessors, but any participant who would like to be in a private room for any or all of the assessment may request that. Physical measurements are likely to take about 30 minutes.

Each year, we will follow up by emailing participants asking them to complete questionnaires that will be a subset of the initial set of questions. Questionnaires will again be implemented through secure Google Forms.

研究の種類

観察的

入学 (推定)

100

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Leslie N Russek, PT, DPT, PhD
  • 電話番号:315-212-2851
  • メール:Lrussek@clarkson.edu

研究連絡先のバックアップ

研究場所

    • New York
      • Potsdam、New York、アメリカ、13699
        • Clarkson University, Lewis School of Health & Life Sciences
        • コンタクト:
        • コンタクト:
        • 主任研究者:
          • Leslie Russek, PT, DPT, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

Health Science graduate students are typically 20-35 years old, though some non-traditional students might be slightly older.

説明

Inclusion Criteria: Clarkson University Health Sciences students. -

Exclusion Criteria: Other physical conditions that preclude collecting >25% of physical measurements at initial data collection.

-

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
hypermobile - symptomatic
People who meet the diagnostic criteria for hEDS or HSD
non-hypermobile
People who do not meet the diagnostic criteria for generalized joint laxity, hEDS or HSD
hypermobile - non-symptomatic
People with generalized joint laxity but not meeting diagnostic criteria for hEDS/HSD

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Hypermobility status
時間枠:5 years
Subject meets diagnostic criteria for generalized joint hypermobility, hypermobile Ehlers-Danlos Syndrome or Hypermobility Spectrum Disorders. This will be nominal: None, GJH, HSD hEDS.
5 years

二次結果の測定

結果測定
メジャーの説明
時間枠
EuroQol, 5-Dimension, 5-Level (EQ-5D-5L)
時間枠:5 years
5-domain quality of life measure: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It scores each domain on a 1-5 scale, where higher scores indicate greater disability. The scores are not summed.
5 years
Hypermobility Spider Questionnaire
時間枠:5 years
31-item questionnaire quantifying symptoms in 8 domains: Neuromusculoskeletal, Pain, Fatigue, Gastrointestinal, Cardiac Dysautonomia, Urogenital, Anxiety, Depression. Each domain is scored 0-100, where 0 is no symptoms in that domain, and 100 is the most symptoms in that domain.
5 years

その他の成果指標

結果測定
メジャーの説明
時間枠
New comorbidities
時間枠:5 years
New presentation of POTS or MCAS
5 years
Physical activity
時間枠:5 years
Modified International Physical Activity Questionnaire short form measures vigorous, moderate, and light exercises and computes 'metabolic minutes' or METs. Minimum score of 0 indicates no exercise. The maximum possible score allowed is 19,278.
5 years

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出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月20日

一次修了 (推定)

2036年6月20日

研究の完了 (推定)

2036年6月20日

試験登録日

最初に提出

2026年6月15日

QC基準を満たした最初の提出物

2026年6月15日

最初の投稿 (実際)

2026年6月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月22日

QC基準を満たした最後の更新が送信されました

2026年6月17日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

To ensure privacy of health information in a fairly small subject pool.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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