- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07698197
Exercise Intervention and Immunodeficiency
Exercise Intervention in Primary Antibody Deficiency Disorders: A 12-week Feasibility Study
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Ryan Steele, DO, MSc
- Telefonnummer: 57092 203-785-7092
- E-post: r.steele@yale.edu
Studiesteder
-
-
Connecticut
-
Milford, Connecticut, Forente stater, 06460
- Rekruttering
- Bridgeport Hospital
-
North Haven, Connecticut, Forente stater, 06473
- Rekruttering
- Yale New Haven Health
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: App-based exercise intervention
12-week, app-based exercise intervention in adults with primary antibody deficiencies with completion of survey procedures and collection of clinical and laboratory data
|
12 week structured moderate-intensity exercise intervention delivered via a mobile application
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Recruitment rate
Tidsramme: Day 1
|
Number and proportion of eligible individuals who enroll
|
Day 1
|
|
Retention rate
Tidsramme: 12 weeks
|
Number of enrolled participants who complete the 12-week study
|
12 weeks
|
|
Frequency of app usage- Adherence
Tidsramme: 12 weeks
|
Mean number of times app was utilized
|
12 weeks
|
|
Duration of workout- Adherence
Tidsramme: 12 weeks
|
Mean duration of workout in minutes
|
12 weeks
|
|
Mean score Borg Scale of Rating of Perceived Exertion
Tidsramme: 12 weeks
|
Measures exertion on a total scale of 0 (no exertion or resting) to 10 (pushing yourself to the max).
|
12 weeks
|
|
Data completeness
Tidsramme: 12 weeks
|
Proportion of expected study data successfully collected at each time point
|
12 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ryan Steele, DO, MSc, Yale University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2000042319
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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