The Impact of Exercise on Stress, Fatigue, and Quality of Life in Individuals With Primary Immunodeficiency Disease
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|ClinicalTrials.gov Identifier: NCT03211689|
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : September 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Primary Immune Deficiency Disorder Common Variable Immunodeficiency Specific Antibody Deficiency Hypergammaglobulinemia||Other: Exercise Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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).
- Short Form 36 version 2 [ Time Frame: Change during 8 weeks ]Measure of quality of life.
- 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
- 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
- Fatigue Impact Scale [ Time Frame: Change during 8 weeks ]Measure of fatigue.
- Exercise Benefits/Barriers Scale [ Time Frame: Change during 8 weeks ]Measure of perceptions about exercise.
- Perceived Stress Scale 10 [ Time Frame: Change during 8 weeks ]Measure of stress.
- Self-efficacy for Exercise Scale [ Time Frame: Change during 8 weeks ]Measure about ability to comply with exercise program
- Subjective Exercise Experience Scale [ Time Frame: Change during 8 weeks ]Measures perceptions about participation in an exercise program
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211689
|United States, New Jersey|
|Galloway, New Jersey, United States, 08205|
|Principal Investigator:||Kerri Sowers, PT, DPT, NCS||Stockton University|