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

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.

Study Overview

• Status: Completed
• Conditions: Common Variable Immunodeficiency; Hypergammaglobulinemia; Primary Immune Deficiency Disorder; Specific Antibody Deficiency
• Intervention / Treatment: Other: Exercise Program

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Galloway, New Jersey, United States, 08205
      • Stockton University

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form 36 version 2	Measure of quality of life.	Change during 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
Fatigue Impact Scale	Measure of fatigue.	Change during 8 weeks
Exercise Benefits/Barriers Scale	Measure of perceptions about exercise.	Change during 8 weeks
Perceived Stress Scale 10	Measure of stress.	Change during 8 weeks
Self-efficacy for Exercise Scale	Measure about ability to comply with exercise program	Change during 8 weeks
Subjective Exercise Experience Scale	Measures perceptions about participation in an exercise program	Change during 8 weeks

Collaborators and Investigators

• Sponsor: Stockton University
• Collaborators: Nova Southeastern University
• Investigators: Principal Investigator: Kerri Sowers, PT, DPT, NCS, Stockton University

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: July 3, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 4, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Exercise; Quality of Life; Stress; Fatigue
• Additional Relevant MeSH Terms: Immune System Diseases; Immunoproliferative Disorders; Hematologic Diseases; Genetic Diseases, Inborn; Blood Protein Disorders; Fatigue; Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases; Common Variable Immunodeficiency; Hypergammaglobulinemia
• Other Study ID Numbers: IRB00010183; IRB00002823 (Other Identifier: Nova Southeastern University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No