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

Primary Purpose

Primary Immune Deficiency Disorder, Common Variable Immunodeficiency, Specific Antibody Deficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Program
Sponsored by
Stockton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Immune Deficiency Disorder focused on measuring Exercise, Stress, Fatigue, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Stockton University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise Group

Control Group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Short Form 36 version 2
Measure of quality of life.

Secondary Outcome Measures

Infection Incidence
Measure of number of infections that have occurred
Unplanned use of medical provider
Number of unplanned visits to a medical provider
Fatigue Impact Scale
Measure of fatigue.
Exercise Benefits/Barriers Scale
Measure of perceptions about exercise.
Perceived Stress Scale 10
Measure of stress.
Self-efficacy for Exercise Scale
Measure about ability to comply with exercise program
Subjective Exercise Experience Scale
Measures perceptions about participation in an exercise program

Full Information

First Posted
July 3, 2017
Last Updated
September 4, 2018
Sponsor
Stockton University
Collaborators
Nova Southeastern University
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1. Study Identification

Unique Protocol Identification Number
NCT03211689
Brief Title
The Impact of Exercise on Stress, Fatigue, and Quality of Life in Individuals With Primary Immunodeficiency Disease
Official Title
The Impact of Exercise on Stress, Fatigue, and Quality of Life in Individuals With Primary Immunodeficiency Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 27, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stockton University
Collaborators
Nova Southeastern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immune Deficiency Disorder, Common Variable Immunodeficiency, Specific Antibody Deficiency, Hypergammaglobulinemia
Keywords
Exercise, Stress, Fatigue, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Exercise Program
Intervention Description
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 Outcome Measure Information:
Title
Short Form 36 version 2
Description
Measure of quality of life.
Time Frame
Change during 8 weeks
Secondary Outcome Measure Information:
Title
Infection Incidence
Description
Measure of number of infections that have occurred
Time Frame
Change from 8 weeks prior to the start of study to the 8 weeks during the study
Title
Unplanned use of medical provider
Description
Number of unplanned visits to a medical provider
Time Frame
Change from 8 weeks prior to the start of the study to the 8 weeks during the study.
Title
Fatigue Impact Scale
Description
Measure of fatigue.
Time Frame
Change during 8 weeks
Title
Exercise Benefits/Barriers Scale
Description
Measure of perceptions about exercise.
Time Frame
Change during 8 weeks
Title
Perceived Stress Scale 10
Description
Measure of stress.
Time Frame
Change during 8 weeks
Title
Self-efficacy for Exercise Scale
Description
Measure about ability to comply with exercise program
Time Frame
Change during 8 weeks
Title
Subjective Exercise Experience Scale
Description
Measures perceptions about participation in an exercise program
Time Frame
Change during 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri Sowers, PT, DPT, NCS
Organizational Affiliation
Stockton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stockton University
City
Galloway
State/Province
New Jersey
ZIP/Postal Code
08205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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