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Completed

NCT Number: NCT05800262

Dynamic Stability Exercises in Patients With Hypermobile Ehlers-Danlos Syndrome and Hypermobility Spectrum Disorder

Background:

Symptomatic hypermobility may lead to a number of restrictions in daily life. So far, there is a lack of effective treatments. A whole-body dynamic stability exercise intervention targets to stimulate the dynamic stability and activation of the proprioceptive system and thereby intends to improve patients' health. The aim of the current study was to examine the feasibility, acceptability and impact of a whole-body dynamic stability exercise intervention in patients with hypermobile Ehlers-Danlos syndrome and hypermobility spectrum disorder.

The aim of the current study was to examine the feasibility, acceptability and impact of a dynamic stability exercise intervention in patients with hypermobile Ehlers-Danlos syndrome and hypermobility spectrum disorder.

Methods:

This is a mixed-methods feasibility study. Fifteen patients (14 women and 1 man) with hypermobile Ehlers-Danlos syndrome or hypermobility spectrum disorder and chronic pain were recruited from two pain specialist clinics in the South-East of Sweden. A dynamic stability exercise program for daily home-exercise was applied during five physiotherapist led sessions distributed over seven weeks. Patient reported outcome measures (PROMs) included pain and function, psychological well-being and quality of life. The clinical tests included walking and balance. Through qualitative interviews patients and physiotherapists described their experiences of the assessments and intervention. Assessments were done at baseline, after the intervention, and at the 3-month follow-up.

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Key information

Conditions

Hypermobility Syndrome Ehlers-Danlos syndrome type 3 Hypermobile Ehlers-Danlos Syndrome

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samrehab Smärtenheten, the Hospital of Västervik, Västervik, Kalmar County, Sweden

Loading trial locations.

About this study

The specific research questions are:

  • Do retention rates, adherence rates and adverse events allow continuation to a large scale RCT?
  • What are the tendencies of impact of the exercise program on pain, function, psychological well-being and quality of life?
  • Which of the outcome measures used are appropriate and acceptable?
  • What are the patients' and physiotherapists' experiences of the exercise program and protocol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

were adults aged 18 to 67 years old, with generalized hypermobility (castori. A framework), persistent pain (i.e. longer than three months) in at least two of four quadrants of the body and ability to perform the exercises.

Exclusion criteria

Exclusion criteria

were cancer-related pain, underlying neurological disease, presence of severe psychiatric disorders, known substance abuse, patients in the process of finding optimal medication as well as patients with previous experience of similar exercises.

Treatment and study plan

Dynamic stability exercises

Behavioral

A dynamic stability exercise program for daily home-exercise was applied during five physiotherapist led sessions distributed over seven weeks.

Primary outcomes

  1. Identification of suitable measures for a forthcoming RCT

    Time frame: Nine months

    Qualitative and quantitative evaluation through secondaty outcome measures and qualitative interviews with patients and physiotherapists

Secondary outcomes

  1. Pain numeric rating scale

    Time frame: 6 months

    Rating of mean pain last week

  2. Functional Rating Index

    Time frame: 6 months

    Disability regarding daily activities

  3. Multidimensional Fatigue Inventory 20

    Time frame: 6 months

    Five subscales measuring general fatigue, physical fatigue, reduced motivation, reduced activity and mental fatigue.

    Item 19 was removed according to Hagelin (2009).

  4. Arthritis Self-efficacy scale

    Time frame: 6 months

    Twenty items divided into three sub-scales for self-efficacy for physical function, other symptoms and pain.

  5. Stress and Crisis Inventory-93

    Time frame: 6 months

    Thirty-five items on physical and psychological symptoms that can be clinical manifestations of stress.

  6. Tampa Scale for Kinesiophobia

    Time frame: 6 months

    Questionnaire measuring kinesiophobia, 17 items.

  7. Orthostatic Hypotension Questionnaire

    Time frame: 6 months

    Assessment of symptoms and daily activity in relation to orthostatic hypotension. 10 items.

  8. European Quality of Life questionnaire (EQ-5D-3L)

    Time frame: 6 months

    Health related quality of life

  9. Berg balance scale

    Time frame: 6 months

    14 tasks common in daily activities testing balance

  10. Bruininks-Oseretsky Test of Motor Proficiency 2

    Time frame: 6 months

    Nine tasks testing balance

  11. Timed up and go

    Time frame: 6 months

    Mobility, balance, walking ability and fall risk in older adults

  12. 2-minute walk test

    Time frame: 6 months

    Walking ability

  13. Wii balance test using a Wii Balance Board

    Time frame: 6 months

    Balance test. Centre of pressure path length, anterio-posterior and medio-lateral sway measured standing on two feet with eyes open and eyes closed, standing on dominant foot and on non-dominant foot with eyes open. Tests performed according to Schmidt (2017), but during 60 seconds instead of 30 seconds.

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Collaborators

  • Linkoeping University
  • Länssjukhuset i Kalmar län
  • Medical Research Council of Southeast Sweden

Registry information

Official study title

Dynamic Stability Exercises in Patients With Hypermobile Ehlers-Danlos Syndrome and Hypermobility Spectrum Disorder - a Mixed-methods Feasibility Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2023
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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