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

• ClinicalTrials.gov Identifier: NCT03211689
• Recruitment Status: Completed
• First Posted: July 7, 2017
• Last Update Posted: September 6, 2018
• Sponsor: Stockton University
• Collaborator: Nova Southeastern University
• Information provided by (Responsible Party): Kerri Sowers PT, DPT, NCS, Stockton University

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	Not Applicable

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 (Clinical Trial)
• 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: June 27, 2017
• Actual Primary Completion Date: December 31, 2017
• Actual Study Completion Date: December 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).

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Infection Incidence [ Time Frame: 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
2. Unplanned use of medical provider [ Time Frame: 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
3. Fatigue Impact Scale [ Time Frame: Change during 8 weeks ]
   Measure of fatigue.
4. Exercise Benefits/Barriers Scale [ Time Frame: Change during 8 weeks ]
   Measure of perceptions about exercise.
5. Perceived Stress Scale 10 [ Time Frame: Change during 8 weeks ]
   Measure of stress.
6. Self-efficacy for Exercise Scale [ Time Frame: Change during 8 weeks ]
   Measure about ability to comply with exercise program
7. Subjective Exercise Experience Scale [ Time Frame: Change during 8 weeks ]
   Measures perceptions about participation in an exercise program

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

United States, New Jersey

Stockton University

Galloway, New Jersey, United States, 08205

Sponsors and Collaborators

Stockton University

Nova Southeastern University

Investigators

• Principal Investigator: Kerri Sowers, PT, DPT, NCS; Stockton University

More Information

• Responsible Party: Kerri Sowers PT, DPT, NCS, Assistant Professor of Health Science, Stockton University
• ClinicalTrials.gov Identifier: NCT03211689
• Other Study ID Numbers: IRB00010183; IRB00002823 ( Other Identifier: Nova Southeastern University )
• First Posted: July 7, 2017
• Last Update Posted: September 6, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kerri Sowers PT, DPT, NCS, Stockton University:

Exercise; Stress; Fatigue; Quality of Life

Additional relevant MeSH terms:

Hypergammaglobulinemia; Immunologic Deficiency Syndromes; Common Variable Immunodeficiency; Fatigue; Immune System Diseases; Blood Protein Disorders; Hematologic Diseases; Immunoproliferative Disorders