Dynamic Stability Exercises in Patients With Hypermobile Ehlers-Danlos Syndrome and Hypermobility Spectrum Disorder
- Conditions
- Hypermobile Ehlers-Danlos SyndromeHypermobility Syndrome
- Interventions
- Behavioral: Dynamic stability exercises
- Registration Number
- NCT05800262
- Lead Sponsor
- University Hospital, Linkoeping
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dynamic stability exercise Dynamic stability exercises A dynamic stability exercise program for daily home-exercise was applied during five physiotherapist led sessions distributed over seven weeks.
- Primary Outcome Measures
Name Time Method Identification of suitable measures for a forthcoming RCT Nine months Qualitative and quantitative evaluation through secondaty outcome measures and qualitative interviews with patients and physiotherapists
- Secondary Outcome Measures
Name Time Method Pain numeric rating scale 6 months Rating of mean pain last week
Functional Rating Index 6 months Disability regarding daily activities
Orthostatic Hypotension Questionnaire 6 months Assessment of symptoms and daily activity in relation to orthostatic hypotension. 10 items.
Arthritis Self-efficacy scale 6 months Twenty items divided into three sub-scales for self-efficacy for physical function, other symptoms and pain.
Stress and Crisis Inventory-93 6 months Thirty-five items on physical and psychological symptoms that can be clinical manifestations of stress.
Multidimensional Fatigue Inventory 20 6 months Five subscales measuring general fatigue, physical fatigue, reduced motivation, reduced activity and mental fatigue.
Item 19 was removed according to Hagelin (2009).Tampa Scale for Kinesiophobia 6 months Questionnaire measuring kinesiophobia, 17 items.
Bruininks-Oseretsky Test of Motor Proficiency 2 6 months Nine tasks testing balance
Timed up and go 6 months Mobility, balance, walking ability and fall risk in older adults
European Quality of Life questionnaire (EQ-5D-3L) 6 months Health related quality of life
Wii balance test using a Wii Balance Board 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.
2-minute walk test 6 months Walking ability
Berg balance scale 6 months 14 tasks common in daily activities testing balance
Trial Locations
- Locations (2)
Samrehab Smärtenheten, the Hospital of Västervik
🇸🇪Västervik, Kalmar Län, Sweden
Pain and rehabilitation center, University Hospital of Linkoping.
🇸🇪Linköping, Östergötland, Sweden