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

Hypermobile Ehlers-Danlos Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05800262
• Other study ID #: 1A
• Status: Completed
• Phase: N/A
• Start date: April 19, 2019
• Est. completion date: December 12, 2019

Study information

• Verified date: March 2023
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The specific research questions are: 1. Do retention rates, adherence rates and adverse events allow continuation to a large scale RCT? 2. What are the tendencies of impact of the exercise program on pain, function, psychological well-being and quality of life? 3. Which of the outcome measures used are appropriate and acceptable? 4. What are the patients' and physiotherapists' experiences of the exercise program and protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 12, 2019
• Est. primary completion date: September 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ehlers-Danlos Syndrome
• Hypermobile Ehlers-Danlos Syndrome
• Hypermobility Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Sweden	Pain and rehabilitation center, University Hospital of Linkoping.	Linköping	Östergötland
Sweden	Samrehab Smärtenheten, the Hospital of Västervik	Västervik	Kalmar Län

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Linkoeping	Länssjukhuset i Kalmar län, Linkoeping University, Medical Research Council of Southeast Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of suitable measures for a forthcoming RCT	Qualitative and quantitative evaluation through secondaty outcome measures and qualitative interviews with patients and physiotherapists	Nine months
Secondary	Pain numeric rating scale	Rating of mean pain last week	6 months
Secondary	Functional Rating Index	Disability regarding daily activities	6 months
Secondary	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).	6 months
Secondary	Arthritis Self-efficacy scale	Twenty items divided into three sub-scales for self-efficacy for physical function, other symptoms and pain.	6 months
Secondary	Stress and Crisis Inventory-93	Thirty-five items on physical and psychological symptoms that can be clinical manifestations of stress.	6 months
Secondary	Tampa Scale for Kinesiophobia	Questionnaire measuring kinesiophobia, 17 items.	6 months
Secondary	Orthostatic Hypotension Questionnaire	Assessment of symptoms and daily activity in relation to orthostatic hypotension. 10 items.	6 months
Secondary	European Quality of Life questionnaire (EQ-5D-3L)	Health related quality of life	6 months
Secondary	Berg balance scale	14 tasks common in daily activities testing balance	6 months
Secondary	Bruininks-Oseretsky Test of Motor Proficiency 2	Nine tasks testing balance	6 months
Secondary	Timed up and go	Mobility, balance, walking ability and fall risk in older adults	6 months
Secondary	2-minute walk test	Walking ability	6 months
Secondary	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.	6 months