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Completed

NCT Number: NCT03211689

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

exercise program

Other

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.

Primary outcomes

  1. Short Form 36 version 2

    Time frame: Change during 8 weeks

    Measure of quality of life.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Stockton University

Other

Collaborators

  • Nova Southeastern University

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 7, 2017
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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