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

NCT ID: NCT05800262

Last Updated: 2023-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-19

Study Completion Date

2019-12-12

Brief Summary

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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

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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.

Conditions

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Hypermobility Syndrome Hypermobile Ehlers-Danlos Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dynamic stability exercise

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

Group Type EXPERIMENTAL

Dynamic stability exercises

Intervention Type BEHAVIORAL

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

Interventions

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Dynamic stability exercises

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role collaborator

Länssjukhuset i Kalmar län

OTHER_GOV

Sponsor Role collaborator

Medical Research Council of Southeast Sweden

OTHER_GOV

Sponsor Role collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

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Helena Romero

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helena Romero

Role: PRINCIPAL_INVESTIGATOR

Smärt- och rehabcentrum, Universitetssjukhuset i Linköping

Locations

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Samrehab Smärtenheten, the Hospital of Västervik

Västervik, Kalmar County, Sweden

Site Status

Pain and rehabilitation center, University Hospital of Linkoping.

Linköping, Östergötland County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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1A

Identifier Type: -

Identifier Source: org_study_id

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