Pilates for Hypermobility: A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intervention Feasibility
研究概览
简要总结
This study is looking at whether Pilates-based exercise can help with hypermobility-related symptoms, like pain.
详细描述
In this study, investigators are looking at whether 6 weeks of Pilates-based exercise led by a licensed physical therapist can help with hypermobility-related symptoms, like pain. Pilates is a gentle mind-body exercise with an emphasis on muscular control, postural awareness, and breathing that may be particularly well-suited for managing hypermobility. Exercises are mostly floor-based and focus on developing muscular strength and stability which may improve pain and symptom management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old;
- •Self-reported hypermobility with confirmed or suspected diagnosis of hEDS/HSD;
- •Self-reported persistent pain ≥ 3 months;
- •A minimum of 3/10 self-reported pain intensity in the past week
- •Able to get on and off the floor without assistance;
- •Able to communicate fluently in English; and
- •Able to provide written, informed consent
排除标准
- •Regular ongoing mind-body practice (e.g. Tai chi, yoga, pilates) defined as a regular weekly practice of at least 20min/week over the past 6 months;
- •Recent surgery or acute bone, joint or nerve injury (<6 months);
- •Have a history of a severe or progressive neurological or movement disorder;
- •Pregnant, planning to become pregnant during the study, or currently breast feeding;
- •Unable to get on and off the floor without assistance;
- •Unable to complete study procedures due to cognitive impairment;
- •Unable to provide written, informed consent; or
- •Currently participating in or planning to participate in another physical activity, mind-body or pain-related intervention research study in the next 4 months.
研究组 & 干预措施
Enhanced Usual Care
6 weeks of once weekly educational seminars pertaining to hypermobility symptom management
干预措施: Education (Behavioral)
Pilates
6 weeks of once weekly in-person Pilates-based exercise classes
干预措施: Pilates (Behavioral)
结局指标
主要结局
Intervention Feasibility
时间窗: Enrollment to end of intervention (week 6) and follow-up (week 12)
Recruitment, Retention, Attendance
Acceptability
时间窗: Enrollment to end of intervention (week 6)
Treatment Helpfulness Questionnaire (THQ): The THQ is a single-item measure that evaluates the perception of helpfulness of an intervention. Participants will be asked to rate the helpfulness of the intervention to which they are randomized on a scale of -5 (extremely harmful) to 5 (extremely helpful) with 0 indicating "neutral."
次要结局
- Pain intensity(Baseline, week 6 and week 12)
- Pain interference(Baseline, week 6 and week 12)
- Bristol Questionnaire(Baseline, week 6 and week 12)
- WPI(Baseline, week 6 and week 12)
- PCS(Baseline, week 6 and week 12)
- MAIA-2(Baseline, week 6 and week 12)
- TSK(Baseline, week 6 and week 12)
- SHS(Baseline, week 6 and week 12)
- Overall physical and mental health(Baseline, week 6 and week 12)
- Heartrate Variability(Enrollment to end of intervention (week 6) and follow-up (week 12))
- Functional mobility(Enrollment to end of intervention (week 6) and follow-up (week 12))
- Functional endurance(Enrollment to end of intervention (week 6) and follow-up (week 12))
研究者
Samantha Meints
Assistant Professor
Brigham and Women's Hospital