- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07698197
Exercise Intervention and Immunodeficiency
Exercise Intervention in Primary Antibody Deficiency Disorders: A 12-week Feasibility Study
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Ryan Steele, DO, MSc
- Telefonnummer: 57092 203-785-7092
- E-post: r.steele@yale.edu
Studieorter
-
-
Connecticut
-
Milford, Connecticut, Förenta staterna, 06460
- Rekrytering
- Bridgeport Hospital
-
North Haven, Connecticut, Förenta staterna, 06473
- Rekrytering
- Yale New Haven Health
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Recruitment rate
Tidsram: Day 1
|
Number and proportion of eligible individuals who enroll
|
Day 1
|
|
Retention rate
Tidsram: 12 weeks
|
Number of enrolled participants who complete the 12-week study
|
12 weeks
|
|
Frequency of app usage- Adherence
Tidsram: 12 weeks
|
Mean number of times app was utilized
|
12 weeks
|
|
Duration of workout- Adherence
Tidsram: 12 weeks
|
Mean duration of workout in minutes
|
12 weeks
|
|
Mean score Borg Scale of Rating of Perceived Exertion
Tidsram: 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
Tidsram: 12 weeks
|
Proportion of expected study data successfully collected at each time point
|
12 weeks
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Ryan Steele, DO, MSc, Yale University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2000042319
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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