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

NCT05800262 | Completed

• 1 other identifier: 1A
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypermobility Syndrome; Hypermobile Ehlers-Danlos Syndrome

Keywords

Hypermobility, exercise intervention, feasibility study, EDS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Pain numeric rating scale

  6 months

• Functional Rating Index

  6 months

• Multidimensional Fatigue Inventory 20

  6 months

• Arthritis Self-efficacy scale

  6 months

• Stress and Crisis Inventory-93

  6 months

Study Arms (1)

Dynamic stability exercise

EXPERIMENTAL

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

Behavioral: Dynamic stability exercises

Interventions

Dynamic stability exercises BEHAVIORAL

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

Dynamic stability exercise

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University Hospital, Linkoeping: lead
• Linkoeping University: collaborator
• Länssjukhuset i Kalmar län: collaborator
• Medical Research Council of Southeast Sweden: collaborator

Study Sites (2)

Samrehab Smärtenheten, the Hospital of Västervik

Västervik, Kalmar County, 59333, Sweden

Location

Pain and rehabilitation center, University Hospital of Linkoping.

Linköping, Östergötland County, 587 37, Sweden

Location

MeSH Terms

Conditions

Ehlers-Danlos syndrome type 3

Study Officials

• Helena Romero

  Smärt- och rehabcentrum, Universitetssjukhuset i Linköping

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: April 19, 2019
• Primary Completion: September 12, 2019
• Study Completion: December 12, 2019
• Last Updated: April 5, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

SE (2)