Dynamic Stability Exercises in Patients With Hypermobile Ehlers-Danlos Syndrome and Hypermobility Spectrum Disorder - a Mixed-methods Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Identification of suitable measures for a forthcoming RCT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Identification of suitable measures for a forthcoming RCT
时间窗: Nine months
Qualitative and quantitative evaluation through secondaty outcome measures and qualitative interviews with patients and physiotherapists
次要结局
- Pain numeric rating scale(6 months)
- Functional Rating Index(6 months)
- Orthostatic Hypotension Questionnaire(6 months)
- Arthritis Self-efficacy scale(6 months)
- Stress and Crisis Inventory-93(6 months)
- Multidimensional Fatigue Inventory 20(6 months)
- Tampa Scale for Kinesiophobia(6 months)
- Bruininks-Oseretsky Test of Motor Proficiency 2(6 months)
- Timed up and go(6 months)
- European Quality of Life questionnaire (EQ-5D-3L)(6 months)
- Wii balance test using a Wii Balance Board(6 months)
- 2-minute walk test(6 months)
- Berg balance scale(6 months)
研究者
Helena Romero
Physiotherapist
University Hospital, Linkoeping