The Impact of Exercise on Stress, Fatigue, and Quality of Life in Individuals With Primary Immunodeficiency Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Short Form 36 version 2
研究概览
简要总结
This aim of this research project is to determine if low to moderate level exercise can have an impact on stress, fatigue, and quality of life for individuals diagnosed with a primary immunodeficiency disease. This 8-week study will compare participants engaging in a semi-customized, home exercise program (exercise intervention group) to participants performing normal activities (non-exercise control group). This study will track stress, fatigue, and quality of life in individuals with a diagnosis of primary immunodeficiency disease, using standardized questionnaires, journals, and interviews.
详细描述
This aim of this research project is to determine if low to moderate level exercise can have an impact on stress, fatigue, and quality of life for individuals diagnosed with a primary immunodeficiency disease. Many individuals diagnosed with primary immunodeficiency disease report chronic fatigue and/or pain, which can potentially limit their participation in exercise and physical activities. Research shows that regular exercise can improve both physical and mental health for individuals diagnosed with a chronic medical condition. Exercise is a healthy and low-cost alternative to some medications, and may be an effective addition to the treatment plan for many patients with primary immunodeficiency disease. Research also suggests that low level exercise may be beneficial to immune function, while intense, or prolonged exercise can be harmful. This 8-week study will compare participants engaging in a semi-customized, home exercise program (exercise intervention group) to participants performing normal activities (non-exercise control group). This study will track stress, fatigue, and quality of life, using standardized questionnaires, journals, and interviews. Weekly contact will be made with all participants throughout the 8 weeks of the study. Individuals in the exercise group will be asked to complete up to 150 minutes of exercise, per week, at the 11-14 rating of perceived exertion. Participants who are randomized to the control group will continue their normal activities; they will also be given the opportunity to participate in the exercise program at the end of the 8 week study. To help assess the safety of a low to moderate level exercise program for individuals with primary immunodeficiency disease, this research will track the number of infections, non-planned medical visits, or increased medication usage during the study (compared to 8 weeks prior to the intervention). This research will help provide valuable information about the safety and effectiveness of an exercise program for individuals with a primary immunodeficiency disease.
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 of age or older.
- •Physician diagnosis of a primary immunodeficiency disease (as evidenced by physician letter or medical documentation/report)
- •Willingness to participate in eight-week exercise program
排除标准
- •Current participation in a structured exercise program for greater than 75 minutes per week
- •Any medical condition that prevents participation in a low to moderate level exercise program (such as, but not limited to, uncontrolled asthma, unstable cardiac condition, acute orthopedic injury which requires restricted activities)
研究组 & 干预措施
Exercise Group
Participants will engage in up to 150 minutes of exercise per week, at a level of 11-14 on the Borg Rate of Perceived Exertion scale.
干预措施: Exercise Program (Other)
Control Group
Participants will continue normal activities, with no new participation in exercise program (may engage in less than 75 minutes of non-structured exercise per week).
结局指标
主要结局
Short Form 36 version 2
时间窗: Change during 8 weeks
Measure of quality of life.
次要结局
- Infection Incidence(Change from 8 weeks prior to the start of study to the 8 weeks during the study)
- Unplanned use of medical provider(Change from 8 weeks prior to the start of the study to the 8 weeks during the study.)
- Fatigue Impact Scale(Change during 8 weeks)
- Exercise Benefits/Barriers Scale(Change during 8 weeks)
- Perceived Stress Scale 10(Change during 8 weeks)
- Self-efficacy for Exercise Scale(Change during 8 weeks)
- Subjective Exercise Experience Scale(Change during 8 weeks)
研究者
Kerri Sowers PT, DPT, NCS
Assistant Professor of Health Science
Stockton University