Physical Activity and Hidradenitis Suppurativa: A Novel Controlled Trial Investigating Functional Performance and Activity Limitations and Assessing the Benefits of an Outcome Measures Driven Exercise Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Change in Functional Strength/Endurance as Measured by 30-second chair-stand test
研究概览
简要总结
The purpose of the study is to characterize the challenges to physical activity and exercise for HS patients and design an exercise program (EP) with evidence-based techniques and examine its outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years old to 80 years old
- •Have diagnosis of HS confirmed by a dermatologist
- •Able to provide informed consent
- •For the extended portion of the study: Classified as having moderate-to-severe HS as per the IHS-4 criteria
排除标准
- •Individuals who are not yet adults
- •Women known to be pregnant
- •Prisoners
- •Subjects, who in the opinion of the PI, cannot comply with the study procedures
研究组 & 干预措施
Home Exercise EP Group
Participants in this group will follow an at home personalized EP for up to 12 weeks.
干预措施: Home Exercise Program (Behavioral)
Short EP Group
Participants in this group will be enrolled in the short EP program.
干预措施: Short Exercise Program (Behavioral)
结局指标
主要结局
Change in Functional Strength/Endurance as Measured by 30-second chair-stand test
时间窗: Baseline and up to 12 weeks
Determines how many times a person can rise from a chair and sit down again in 30 seconds while keeping their arms crossed over their chest. The test will assess lower body strength and endurance and will be reported using a composite score of the number of times completed.
Change in Functional Strength/Endurance as measured by six-minute walk test
时间窗: Baseline and up to 12 weeks
Six-minute walk measures overall functioning capacity, and lower body muscle strength/ endurance, with a composite score reported in meters.
Change in Functional Strength as measured by hand grip strength test
时间窗: Baseline and up to 12 weeks
It is a measure of upper body muscular strength measured in kilograms.
次要结局
- Quality of life impairment as measured by the DLQI(Baseline, up to 12 weeks)
- Change in Physical activity as measured by the International Physical Activity Questionnaire (IPAQ)(Baseline, up to 12 weeks)
- Quality of life impairment as measured by the HiSQOL(Baseline, up to 12 weeks)
- Average pain as assessed by the Numerical Rating Scale (NRS)(Up to 8 weeks)
- Change in Level of Activity as measured by the average number of steps daily(Baseline, up to 12 weeks)
- Change in Severity of HS score using the IHS-4(Baseline, up to 12 weeks)
研究者
Hadar Lev-Tov
Associate Professor of Clinical
University of Miami