Progressive Heavy Shoulder Resistance Training for Patients With Hypermobility Spectrum Disorders and Shoulder Symptoms: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Patient recruitment
研究概览
简要总结
Hypermobility Spectrum Disorders (HSD) is a recent diagnosis that covers joint hypermobility with one or more secondary symptomatic musculoskeletal manifestations. Current clinical management of this population with shoulder symptoms is a non-standardized combination of physiotherapy modalities including exercise prescription. There is evidence suggesting that progressive heavy resistance training increases muscle strength and tendon stiffness, which may be valuable for treatment of this population.
The aim of this study is to evaluate the feasibility of progressive heavy shoulder resistance training (PHSRT) for adults with HSD and shoulder symptoms.
详细描述
Hypermobility Spectrum Disorders (HSD) is a recent diagnosis that covers joint hypermobility with one or more secondary symptomatic musculoskeletal manifestations. Current clinical management of this population with shoulder symptoms is a non-standardized combination of physiotherapy modalities including exercise prescription. There is evidence suggesting that progressive heavy resistance training increases muscle strength and tendon stiffness, which may be valuable for treatment of this population.
The aim of this study is to evaluate the feasibility of progressive heavy shoulder resistance training (PHSRT) for adults with HSD and shoulder symptoms before safely performing a definitive RCT-study in a large cohort. The objectives are to address whether PHSRT is feasible regarding i) patient recruitment and retention, ii) adherence to exercise protocol and its progression levels, iii) completion of objective outcome measures, and iv) registering potential flare up in shoulder symptoms.
Study progression criteria are based on a traffic light system of green (go), amber (amend) and red (stop). Results of these progression criteria will be evaluated by the investigator group, who will recommend amendments that need to be made before proceeding with the definitive RCT.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 - 65
- •Generalized HSD (G-HSD) defined with Beighton score cut-off ≥ 5 for women up to the age of 50 years and ≥ 4 for those above 50 years and all men [21, 22] or historical HSD (H-HSD) if the Beighton score was 1 point below the age and sex-specific cut-off AND the five-part questionnaire (5PQ) was positive (= at least two positive items). In patients with acquired joint limitations (past surgery, wheelchair, amputations) affecting the Beighton score calculation, the assessment of GJH only included a positive 5 part-questionnaire.
- •Present with one or more secondary symptomatic musculoskeletal manifestations, defined as either musculoskeletal pain in minimum one shoulder for at least three months or recurrent joint dislocations or joint instability without a reported history of trauma defined as: a) minimum three atraumatic dislocations in same shoulder or minimum two atraumatic dislocations in two different joints (minimum one in the shoulder) occurring at different times, or b) medical confirmation of joint instability in minimum two joints (minimum one in the shoulder) not related to trauma.
排除标准
- •Clinically suspected referred pain from the cervical spine
- •Systemic rheumatic diseases (e.g. Marfans, Stickler's or Loeys Dietz syndromes)
- •Neurological diseases
- •Pregnancy or childbirth within the latest year
- •Shoulder surgery within the past year
- •Inability to speak and understand Danish.
结局指标
主要结局
Patient recruitment
时间窗: 4 months
Green: Inclusion rate of one patient per general practitioner or physiotherapist every month (approximately n=6-8/month). Amber: If the recruitment rate falls behind, screening logs and reasons for exclusion will be explored after the first month in order to adjust eligibility criteria (n\<6 after first month) Red: No recruitment after two months
Completion of the outcome measures
时间窗: Baseline measures
Green: 120 minutes for completing all objective outcome measures and at least 67% of patients answering that it was an acceptable duration Amber: Between 121-150 minutes or between 50-66% of patients answering that it was an acceptable duration Red: \>150 minutes or \<50% of patients answering that it was an acceptable duration
Patient retention
时间窗: 4 months
Green: 10 or more patients show up at 16-weeks follow up Amber: 6-9 patients show up at 16-weeks follow up Red: Less than 6 patients show up at 16-weeks follow up
Adherence to training intervention
时间窗: 4 months
Green: At least 75% of patients adhering to at least 75% of training sessions Amber: 50-75% of patients adhering to 50-75% of training sessions Red: \<50% of patients adhering to \<50% of training sessions
Adverse events
时间窗: 4 months
Green: No or minor adverse events with no patients discontinuing the trial Amber: Minor or serious adverse events leading to 2 or less patients discontinuing the trial Red: Serious adverse events leading to \>2 patients discontinuing the trial
次要结局
- WOSI(4 months)
- Pain level(4 months)
- Checklist Individual Strength (CIS)(4 months)
- IPAQ short version(4 months)
- COOP/WONCA(4 months)
- Tampa Scale of Kinesiophobia (TSK-11)(4 months)
- Global Perceived Effect (GPE)(4 months)
- EQ-5D-5L Health status questionnaire(4 months)
- Isometric shoulder strength(4 months)
- Active and passive shoulder range of motion(4 months)
- Shoulder proprioception(4 months)
研究者
Behnam Liaghat
Principal Investigator
University of Southern Denmark