Exercise Intervention in Primary Antibody Deficiency Disorders: A 12-week Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
The purpose of this study is to assess if a 12-week exercise program is safe, practical, and acceptable for adults with primary antibody deficiencies. It also looks at whether the program can improve the quality of life and help the immune system work better.
详细描述
Study activities will include:
Completion of health questionnaires Participation in a 12-week exercise program using a mobile application Having your exercise activity tracked through the mobile application Reporting any symptoms or infections that develop Providing blood samples for immune-related testing at your patient visits. Completion of assessments at the beginning and end of study
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
- •Diagnosed with one of the following primary antibody deficiencies: IgG subclass deficiency, selective IgA deficiency, selective IgM deficiency, or specific antibody deficiency
- •Receiving care in the Section of Rheumatology, Allergy & Immunology
- •Able and willing to participate in a moderate-intensity exercise program. Patients will be screened using the American College of Sports Medicine (ACSM) Pre- participation Screening Guidelines. This algorithm assesses patients for cardiovascular, renal, and metabolic disease. Those patients determined to not require further medical clearance to participate in exercise will be included.
排除标准
- •Receipt of immunoglobulin (Ig) replacement therapy
- •Use of immunosuppressive or immunomodulatory medications (e.g., chronic systemic corticosteroids, B-cell-depleting therapies)
- •Medical contraindications to moderate-intensity exercise as determined by clinical assessment using the previously discussed ACSM Pre-participation Screening Guidelines.
- •Other risk factors/medical conditions that would limit safe participation in exercise as determined by clinical assessment, including active rheumatologic conditions including active rheumatoid arthritis.
研究组 & 干预措施
App-based exercise intervention
12-week, app-based exercise intervention in adults with primary antibody deficiencies with completion of survey procedures and collection of clinical and laboratory data
干预措施: App-based exercise intervention (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: Day 1
Number and proportion of eligible individuals who enroll
Retention rate
时间窗: 12 weeks
Number of enrolled participants who complete the 12-week study
Frequency of app usage- Adherence
时间窗: 12 weeks
Mean number of times app was utilized
Duration of workout- Adherence
时间窗: 12 weeks
Mean duration of workout in minutes
Mean score Borg Scale of Rating of Perceived Exertion
时间窗: 12 weeks
Measures exertion on a total scale of 0 (no exertion or resting) to 10 (pushing yourself to the max).
Data completeness
时间窗: 12 weeks
Proportion of expected study data successfully collected at each time point
次要结局
未报告次要终点