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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00002823 | Other Identifier | Nova Southeastern University |
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| Name | Class |
|---|---|
| Nova Southeastern University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Group | Experimental | 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. |
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| Control Group | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form 36 version 2 | Measure of quality of life. | Change during 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Infection Incidence | Measure of number of infections that have occurred | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerri Sowers, PT, DPT, NCS | Stockton University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stockton University | Galloway | New Jersey | 08205 | United States |
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| Change from 8 weeks prior to the start of the study to the 8 weeks during the study. |
| Fatigue Impact Scale | Measure of fatigue. | Change during 8 weeks |
| Exercise Benefits/Barriers Scale | Measure of perceptions about exercise. | Change during 8 weeks |
| Perceived Stress Scale 10 | Measure of stress. | Change during 8 weeks |
| Self-efficacy for Exercise Scale | Measure about ability to comply with exercise program | Change during 8 weeks |
| Subjective Exercise Experience Scale | Measures perceptions about participation in an exercise program | Change during 8 weeks |
| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| D017074 | Common Variable Immunodeficiency |
| D006942 | Hypergammaglobulinemia |
| D009043 | Motor Activity |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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