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

NCT03211689 | Completed

• 2 other identifiers: IRB00010183IRB00002823
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Immune Deficiency Disorder; Common Variable Immunodeficiency; Specific Antibody Deficiency; Hypergammaglobulinemia

Keywords

Exercise; Stress; Fatigue; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Short Form 36 version 2

  Measure of quality of life.

  Change during 8 weeks

Secondary Outcomes (7)

• Infection Incidence

  Change from 8 weeks prior to the start of study to the 8 weeks during the study

• Unplanned use of medical provider

  Change from 8 weeks prior to the start of the study to the 8 weeks during the study.

• Fatigue Impact Scale

  Change during 8 weeks

• Exercise Benefits/Barriers Scale

  Change during 8 weeks

• Perceived Stress Scale 10

  Change during 8 weeks

Study Arms (2)

Exercise Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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).

Interventions

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.

Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stockton University: lead
• Nova Southeastern University: collaborator

Study Sites (1)

Stockton University

Galloway, New Jersey, 08205, United States

Location

MeSH Terms

Conditions

Primary Immunodeficiency Diseases; Common Variable Immunodeficiency; Hypergammaglobulinemia; Motor Activity; Fatigue

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kerri Sowers, PT, DPT, NCS

  Stockton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Health Science

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 7, 2017
• Study Start: June 27, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)