The Impact of Exercise on Stress, Fatigue, and Quality of Life in Individuals With Primary Immunodeficiency Disease

Not Applicable

Completed

• Conditions: Hypergammaglobulinemia; Specific Antibody Deficiency; Primary Immune Deficiency Disorder; Common Variable Immunodeficiency
• Interventions: Other: Exercise Program

• Registration Number: NCT03211689
• Lead Sponsor: Stockton University

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.

Study Timeline

• Study Start: 2017-06-27
• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-06
• Study First Posted: 2017-07-07
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Group	Exercise Program	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.

Primary Outcome Measures

Name	Time	Method
Short Form 36 version 2	Change during 8 weeks	Measure of quality of life.

Secondary Outcome Measures

Name	Time	Method
Infection Incidence	Change from 8 weeks prior to the start of study to the 8 weeks during the study	Measure of number of infections that have occurred
Unplanned use of medical provider	Change from 8 weeks prior to the start of the study to the 8 weeks during the study.	Number of unplanned visits to a medical provider
Fatigue Impact Scale	Change during 8 weeks	Measure of fatigue.
Exercise Benefits/Barriers Scale	Change during 8 weeks	Measure of perceptions about exercise.
Perceived Stress Scale 10	Change during 8 weeks	Measure of stress.
Self-efficacy for Exercise Scale	Change during 8 weeks	Measure about ability to comply with exercise program
Subjective Exercise Experience Scale	Change during 8 weeks	Measures perceptions about participation in an exercise program

Trial Locations

Locations (1)

Stockton University; 🇺🇸 Galloway, New Jersey, United States