Clinical trial NCT05800262: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypermobility Syndrome
Hypermobile Ehlers-Danlos Syndrome
Keywords: Hypermobility, exercise intervention, feasibility study, EDS
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
Collaborators: name: Linkoeping University
name: Länssjukhuset i Kalmar län
name: Medical Research Council of Southeast Sweden
First posted: 2023-04-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: Identification of suitable measures for a forthcoming RCT
timeFrame: Nine months
Secondary outcomes:
measure: Pain numeric rating scale
timeFrame: 6 months
measure: Functional Rating Index
timeFrame: 6 months
measure: Multidimensional Fatigue Inventory 20
timeFrame: 6 months
measure: Arthritis Self-efficacy scale
timeFrame: 6 months
measure: Stress and Crisis Inventory-93
timeFrame: 6 months
measure: Tampa Scale for Kinesiophobia
timeFrame: 6 months
measure: Orthostatic Hypotension Questionnaire
timeFrame: 6 months
measure: European Quality of Life questionnaire (EQ-5D-3L)
timeFrame: 6 months
measure: Berg balance scale
timeFrame: 6 months
measure: Bruininks-Oseretsky Test of Motor Proficiency 2
timeFrame: 6 months
measure: Timed up and go
timeFrame: 6 months
measure: 2-minute walk test
timeFrame: 6 months
measure: Wii balance test using a Wii Balance Board
timeFrame: 6 months
Other outcomes:
Locations:
city: Västervik
country: Sweden
facility: Samrehab Smärtenheten, the Hospital of Västervik
state: Kalmar Län
city: Linköping
country: Sweden
facility: Pain and rehabilitation center, University Hospital of Linkoping.
state: Östergötland
Study officials:
affiliation: Smärt- och rehabcentrum, Universitetssjukhuset i Linköping
name: Helena Romero
role: PRINCIPAL_INVESTIGATOR
References: