Common Variable Immunodeficiency Clinical Trial
Official title:
The Impact of Exercise on Stress, Fatigue, and Quality of Life in Individuals With Primary Immunodeficiency Disease
Verified date | September 2018 |
Source | Stockton University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | December 31, 2017 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
United States | Stockton University | Galloway | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Stockton University | Nova Southeastern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short Form 36 version 2 | Measure of quality of life. | Change during 8 weeks | |
Secondary | 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 | |
Secondary | Unplanned use of medical provider | Number of unplanned visits to a medical provider | Change from 8 weeks prior to the start of the study to the 8 weeks during the study. | |
Secondary | Fatigue Impact Scale | Measure of fatigue. | Change during 8 weeks | |
Secondary | Exercise Benefits/Barriers Scale | Measure of perceptions about exercise. | Change during 8 weeks | |
Secondary | Perceived Stress Scale 10 | Measure of stress. | Change during 8 weeks | |
Secondary | Self-efficacy for Exercise Scale | Measure about ability to comply with exercise program | Change during 8 weeks | |
Secondary | Subjective Exercise Experience Scale | Measures perceptions about participation in an exercise program | Change during 8 weeks |
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