Hypermobility SyndromeNCT05800262
Dynamic Stability Exercises in Patients With Hypermobile Ehlers-Danlos Syndrome and Hypermobility Spectrum Disorder
A study testing Dynamic stability exercises in people with Hypermobility Syndrome and Hypermobile Ehlers-Danlos Syndrome, run by University Hospital, Linkoeping at 2 sites in Sweden.
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'… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Hypermobility Syndrome, Hypermobile Ehlers-Danlos Syndrome
- What is being tested?
- Dynamic stability exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesSweden
- Study dates
- 19 Apr 2019to 12 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Pain and rehabilitation center, University Hospital of Linkoping.
Linköping, Östergötland County, 587 37
Samrehab Smärtenheten, the Hospital of Västervik
Västervik, Kalmar County, 59333
About this study
Official title: Dynamic Stability Exercises in Patients With Hypermobile Ehlers-Danlos Syndrome and Hypermobility Spectrum Disorder - a Mixed-methods Feasibility Study
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.
Read more
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.
Read the 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.
- Being tested
- Dynamic stability exercises
- Keywords
- Hypermobility, exercise intervention, feasibility study, EDS
- Medical subject headings
- Ehlers-Danlos syndrome type 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic stability exercisesBehavioural
A dynamic stability exercise program for daily home-exercise was applied during five physiotherapist led sessions distributed over seven weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic stability exercise | Experimental | A dynamic stability exercise program for daily home-exercise was applied during five physiotherapist led sessions distributed over seven weeks. Receives: Behavioral: Dynamic stability exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of suitable measures for a forthcoming RCT
Qualitative and quantitative evaluation through secondaty outcome measures and qualitative interviews with patients and physiotherapists
Measured: Nine months
Secondary outcomes (13)
Pain numeric rating scale
Rating of mean pain last week
Measured: 6 months
Functional Rating Index
Disability regarding daily activities
Measured: 6 months
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).
Measured: 6 months
Arthritis Self-efficacy scale
Twenty items divided into three sub-scales for self-efficacy for physical function, other symptoms and pain.
Measured: 6 months
Stress and Crisis Inventory-93
Thirty-five items on physical and psychological symptoms that can be clinical manifestations of stress.
Measured: 6 months
Tampa Scale for Kinesiophobia
Questionnaire measuring kinesiophobia, 17 items.
Measured: 6 months
Orthostatic Hypotension Questionnaire
Assessment of symptoms and daily activity in relation to orthostatic hypotension. 10 items.
Measured: 6 months
European Quality of Life questionnaire (EQ-5D-3L)
Health related quality of life
Measured: 6 months
Berg balance scale
14 tasks common in daily activities testing balance
Measured: 6 months
Bruininks-Oseretsky Test of Motor Proficiency 2
Nine tasks testing balance
Measured: 6 months
Timed up and go
Mobility, balance, walking ability and fall risk in older adults
Measured: 6 months
2-minute walk test
Walking ability
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start19 Apr 2019
- Primary completion12 Sep 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypermobility SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University, Länssjukhuset i Kalmar län, Medical Research Council of Southeast Sweden
- Responsible party
- Principal investigator, Helena Romero, University Hospital, Linkoeping
- Investigators
- Helena Romero, Principal investigator, Smärt- och rehabcentrum, Universitetssjukhuset i Linköping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800262
- Sponsor's protocol ID
- 1A
- Status last verified
- Mar 2023
- First submitted
- 23 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is available from the authors on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Stability Exercises in Patients With Hypermobile Ehlers-Danlos Syndrome and Hypermobility Spectrum Disorder - a Mixed-methods Feasibility Study
- ClinicalTrials.gov ID
- NCT05800262
- Acronym / sponsor ID
- 1A
- Keywords
- Hypermobility, exercise intervention, feasibility study, EDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Linkoeping University, Länssjukhuset i Kalmar län, Medical Research Council of Southeast Sweden
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dynamic stability exercise | Experimental | Behavioral: Dynamic stability exercisesA dynamic stability exercise program for daily home-exercise was applied during five physiotherapist led sessions distributed over seven weeks. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic stability exercisesA dynamic stability exercise program for daily home-exercise was applied during five physiotherapist led sessions distributed over seven weeks. | Behavioural | Dynamic stability exercise |
Primary outcome
Identification of suitable measures for a forthcoming RCT
Time frame: Nine months
Qualitative and quantitative evaluation through secondaty outcome measures and qualitative interviews with patients and physiotherapists
13 secondary outcomes
Pain numeric rating scale
Time frame: 6 months
Functional Rating Index
Time frame: 6 months
Multidimensional Fatigue Inventory 20
Time frame: 6 months
Arthritis Self-efficacy scale
Time frame: 6 months
Stress and Crisis Inventory-93
Time frame: 6 months
Tampa Scale for Kinesiophobia
Time frame: 6 months
Orthostatic Hypotension Questionnaire
Time frame: 6 months
European Quality of Life questionnaire (EQ-5D-3L)
Time frame: 6 months
Berg balance scale
Time frame: 6 months
Bruininks-Oseretsky Test of Motor Proficiency 2
Time frame: 6 months
Timed up and go
Time frame: 6 months
2-minute walk test
Time frame: 6 months
Wii balance test using a Wii Balance Board
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: Yes. Data is available from the authors on reasonable request.
Related trials for Hypermobility Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Romero principal investigator
Smärt- och rehabcentrum, Universitetssjukhuset i Linköping
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic stability exercises in people with Hypermobility Syndrome and Hypermobile Ehlers-Danlos Syndrome, run by University Hospital, Linkoeping at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of suitable measures for a forthcoming RCT (time frame: Nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.