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NCT Number: NCT07698197

Exercise Intervention and Immunodeficiency

The purpose of this study is to assess if a 12-week exercise program is safe, practical, and acceptable for adults with primary antibody deficiencies. It also looks at whether the program can improve the quality of life and help the immune system work better.

Recruiting

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Key information

Conditions

Primary Antibody Deficiency Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bridgeport Hospital, Milford, Connecticut, United States

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About this study

Study activities will include:

Completion of health questionnaires Participation in a 12-week exercise program using a mobile application Having your exercise activity tracked through the mobile application Reporting any symptoms or infections that develop Providing blood samples for immune-related testing at your patient visits. Completion of assessments at the beginning and end of study

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with one of the following primary antibody deficiencies: IgG subclass deficiency, selective IgA deficiency, selective IgM deficiency, or specific antibody deficiency
  • Receiving care in the Section of Rheumatology, Allergy & Immunology
  • Able and willing to participate in a moderate-intensity exercise program. Patients will be screened using the American College of Sports Medicine (ACSM) Pre- participation Screening Guidelines. This algorithm assesses patients for cardiovascular, renal, and metabolic disease. Those patients determined to not require further medical clearance to participate in exercise will be included.

Exclusion criteria

  • Receipt of immunoglobulin (Ig) replacement therapy
  • Use of immunosuppressive or immunomodulatory medications (e.g., chronic systemic corticosteroids, B-cell-depleting therapies)
  • Medical contraindications to moderate-intensity exercise as determined by clinical assessment using the previously discussed ACSM Pre-participation Screening Guidelines.
  • Other risk factors/medical conditions that would limit safe participation in exercise as determined by clinical assessment, including active rheumatologic conditions including active rheumatoid arthritis.

Treatment and study plan

App-based exercise intervention

Behavioral

12 week structured moderate-intensity exercise intervention delivered via a mobile application

Primary outcomes

  1. Recruitment rate

    Time frame: Day 1

    Number and proportion of eligible individuals who enroll

  2. Retention rate

    Time frame: 12 weeks

    Number of enrolled participants who complete the 12-week study

  3. Frequency of app usage- Adherence

    Time frame: 12 weeks

    Mean number of times app was utilized

  4. Duration of workout- Adherence

    Time frame: 12 weeks

    Mean duration of workout in minutes

  5. Mean score Borg Scale of Rating of Perceived Exertion

    Time frame: 12 weeks

    Measures exertion on a total scale of 0 (no exertion or resting) to 10 (pushing yourself to the max).

  6. Data completeness

    Time frame: 12 weeks

    Proportion of expected study data successfully collected at each time point

Study contacts

Contact information is provided by the study sponsor or research team.

Ryan Steele, DO, MSc

CONTACT

[email protected]

203-785-7092 ext. 57092

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • The Pump

Registry information

Official study title

Exercise Intervention in Primary Antibody Deficiency Disorders: A 12-week Feasibility Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 13, 2026
Registry last updated
Jul 23, 2026

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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