An interventional study of Exercise Program in Primary Immune Deficiency Disorder, Common Variable Immunodeficiency and Specific Antibody Deficiency, sponsored by Stockton University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-06.
Sponsored by Stockton University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Other: Exercise Program
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).
Participants will utilize the Physitrack exercise program to engage in up to 150 minutes of exercise at a rating of 11-14 on the Borg Rate of Perceived Exertion scale, per week.
Short Form 36 version 2
Measure of quality of life.
Time frame: Change during 8 weeks
Infection Incidence
Measure of number of infections that have occurred
Time frame: Change from 8 weeks prior to the start of study to the 8 weeks during the study
Unplanned use of medical provider
Number of unplanned visits to a medical provider
Time frame: Change from 8 weeks prior to the start of the study to the 8 weeks during the study.
Fatigue Impact Scale
Measure of fatigue.
Time frame: Change during 8 weeks
Exercise Benefits/Barriers Scale
Measure of perceptions about exercise.
Time frame: Change during 8 weeks
Perceived Stress Scale 10
Measure of stress.
Time frame: Change during 8 weeks
Self-efficacy for Exercise Scale
Measure about ability to comply with exercise program
Time frame: Change during 8 weeks
Subjective Exercise Experience Scale
Measures perceptions about participation in an exercise program
Time frame: Change during 8 weeks
Plan to share: No
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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Hypergammaglobulinemia
Stockton University