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

Primary Purpose

Hypermobility Syndrome, Hypermobile Ehlers-Danlos Syndrome

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Dynamic stability exercises
Sponsored by
University Hospital, Linkoeping
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypermobility Syndrome focused on measuring Hypermobility, exercise intervention, feasibility study, EDS

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Samrehab Smärtenheten, the Hospital of Västervik
  • Pain and rehabilitation center, University Hospital of Linkoping.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dynamic stability exercise

Arm Description

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

Outcomes

Primary Outcome Measures

Identification of suitable measures for a forthcoming RCT
Qualitative and quantitative evaluation through secondaty outcome measures and qualitative interviews with patients and physiotherapists

Secondary Outcome Measures

Pain numeric rating scale
Rating of mean pain last week
Functional Rating Index
Disability regarding daily activities
Multidimensional Fatigue Inventory 20
Five subscales measuring general fatigue, physical fatigue, reduced motivation, reduced activity and mental fatigue. Item 19 was removed according to Hagelin (2009).
Arthritis Self-efficacy scale
Twenty items divided into three sub-scales for self-efficacy for physical function, other symptoms and pain.
Stress and Crisis Inventory-93
Thirty-five items on physical and psychological symptoms that can be clinical manifestations of stress.
Tampa Scale for Kinesiophobia
Questionnaire measuring kinesiophobia, 17 items.
Orthostatic Hypotension Questionnaire
Assessment of symptoms and daily activity in relation to orthostatic hypotension. 10 items.
European Quality of Life questionnaire (EQ-5D-3L)
Health related quality of life
Berg balance scale
14 tasks common in daily activities testing balance
Bruininks-Oseretsky Test of Motor Proficiency 2
Nine tasks testing balance
Timed up and go
Mobility, balance, walking ability and fall risk in older adults
2-minute walk test
Walking ability
Wii balance test using a Wii Balance Board
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.

Full Information

First Posted
March 23, 2023
Last Updated
March 23, 2023
Sponsor
University Hospital, Linkoeping
Collaborators
Linkoeping University, Länssjukhuset i Kalmar län, Medical Research Council of Southeast Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT05800262
Brief Title
Dynamic Stability Exercises in Patients With Hypermobile Ehlers-Danlos Syndrome and Hypermobility Spectrum Disorder
Official Title
Dynamic Stability Exercises in Patients With Hypermobile Ehlers-Danlos Syndrome and Hypermobility Spectrum Disorder - a Mixed-methods Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 19, 2019 (Actual)
Primary Completion Date
September 12, 2019 (Actual)
Study Completion Date
December 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping
Collaborators
Linkoeping University, Länssjukhuset i Kalmar län, Medical Research Council of Southeast Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypermobility Syndrome, Hypermobile Ehlers-Danlos Syndrome
Keywords
Hypermobility, exercise intervention, feasibility study, EDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dynamic stability exercise
Arm Type
Experimental
Arm Description
A dynamic stability exercise program for daily home-exercise was applied during five physiotherapist led sessions distributed over seven weeks.
Intervention Type
Behavioral
Intervention Name(s)
Dynamic stability exercises
Intervention Description
A dynamic stability exercise program for daily home-exercise was applied during five physiotherapist led sessions distributed over seven weeks.
Primary Outcome Measure Information:
Title
Identification of suitable measures for a forthcoming RCT
Description
Qualitative and quantitative evaluation through secondaty outcome measures and qualitative interviews with patients and physiotherapists
Time Frame
Nine months
Secondary Outcome Measure Information:
Title
Pain numeric rating scale
Description
Rating of mean pain last week
Time Frame
6 months
Title
Functional Rating Index
Description
Disability regarding daily activities
Time Frame
6 months
Title
Multidimensional Fatigue Inventory 20
Description
Five subscales measuring general fatigue, physical fatigue, reduced motivation, reduced activity and mental fatigue. Item 19 was removed according to Hagelin (2009).
Time Frame
6 months
Title
Arthritis Self-efficacy scale
Description
Twenty items divided into three sub-scales for self-efficacy for physical function, other symptoms and pain.
Time Frame
6 months
Title
Stress and Crisis Inventory-93
Description
Thirty-five items on physical and psychological symptoms that can be clinical manifestations of stress.
Time Frame
6 months
Title
Tampa Scale for Kinesiophobia
Description
Questionnaire measuring kinesiophobia, 17 items.
Time Frame
6 months
Title
Orthostatic Hypotension Questionnaire
Description
Assessment of symptoms and daily activity in relation to orthostatic hypotension. 10 items.
Time Frame
6 months
Title
European Quality of Life questionnaire (EQ-5D-3L)
Description
Health related quality of life
Time Frame
6 months
Title
Berg balance scale
Description
14 tasks common in daily activities testing balance
Time Frame
6 months
Title
Bruininks-Oseretsky Test of Motor Proficiency 2
Description
Nine tasks testing balance
Time Frame
6 months
Title
Timed up and go
Description
Mobility, balance, walking ability and fall risk in older adults
Time Frame
6 months
Title
2-minute walk test
Description
Walking ability
Time Frame
6 months
Title
Wii balance test using a Wii Balance Board
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena Romero
Organizational Affiliation
Smärt- och rehabcentrum, Universitetssjukhuset i Linköping
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samrehab Smärtenheten, the Hospital of Västervik
City
Västervik
State/Province
Kalmar Län
ZIP/Postal Code
59333
Country
Sweden
Facility Name
Pain and rehabilitation center, University Hospital of Linkoping.
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
587 37
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data is available from the authors on reasonable request.

Learn more about this trial

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

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