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

Sponsor

Stockton University (Other)

Overall Status

Completed

CT.gov ID

NCT03211689

Collaborator

Nova Southeastern University (Other)

Enrollment

Location

Arms

6.1

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Immune Deficiency Disorder Common Variable Immunodeficiency Specific Antibody Deficiency Hypergammaglobulinemia	Other: Exercise Program	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 27, 2017

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Dec 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise Group 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 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.
No Intervention: Control Group 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).

Arm

Intervention/Treatment

Experimental: Exercise Group

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 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.

No Intervention: Control Group

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).

Outcome Measures

Primary Outcome Measures

Short Form 36 version 2 [Change during 8 weeks]
Measure of quality of life.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)