Clinical trial NCT03211689: The Impact of Exercise on Stress, Fatigue, and Quality of Life in Individuals With Primary Immunodeficiency Disease
Official title: The Impact of Exercise on Stress, Fatigue, and Quality of Life in Individuals With Primary Immunodeficiency Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Immune Deficiency Disorder
Common Variable Immunodeficiency
Specific Antibody Deficiency
Hypergammaglobulinemia
Keywords: Exercise
Stress
Fatigue
Quality of Life
Lead sponsor: Stockton University
Sponsor class: OTHER
Collaborators: name: Nova Southeastern University
First posted: 2017-07-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Short Form 36 version 2
timeFrame: Change during 8 weeks
Secondary outcomes:
measure: Infection Incidence
timeFrame: Change from 8 weeks prior to the start of study to the 8 weeks during the study
measure: Unplanned use of medical provider
timeFrame: Change from 8 weeks prior to the start of the study to the 8 weeks during the study.
measure: Fatigue Impact Scale
timeFrame: Change during 8 weeks
measure: Exercise Benefits/Barriers Scale
timeFrame: Change during 8 weeks
measure: Perceived Stress Scale 10
timeFrame: Change during 8 weeks
measure: Self-efficacy for Exercise Scale
timeFrame: Change during 8 weeks
measure: Subjective Exercise Experience Scale
timeFrame: Change during 8 weeks
Other outcomes:
Locations:
city: Galloway
country: United States
facility: Stockton University
state: New Jersey
Study officials:
affiliation: Stockton University
name: Kerri Sowers, PT, DPT, NCS
role: PRINCIPAL_INVESTIGATOR
References: