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

Common Variable Immunodeficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03211689
• Other study ID #: IRB00010183
• Secondary ID: IRB00002823
• Status: Completed
• Phase: N/A
• Start date: June 27, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: September 2018
• Source: Stockton University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Common Variable Immunodeficiency
• Fatigue
• Hypergammaglobulinemia
• Immunologic Deficiency Syndromes
• Primary Immune Deficiency Disorder
• Specific Antibody Deficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Stockton University	Galloway	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Stockton University	Nova Southeastern University

Country where clinical trial is conducted

United States, 

Outcome

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