- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00483275
Fall Prevention by Alfacalcidol and Training (SPALT)
Effects of a Multi-modal 12-month-intervention With Alfacalcidol Plus Calcium, Patient Education and a Mobility Program on the Number of Fallers Among Patients With an Impaired Kidney Function Aged 65 and Older.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The risk of falling increases with age. An impaired renal function is an additional risk factor. Guidelines and systematic reviews suggest, that multimodal interventions are most likely to control this risk. This study evaluates, if patients at high risk for falls will benefit from a multimodal intervention simple and feasible enough to be transferred into general practice. Participants will be randomized either into an intervention group or a control group receiving usual care.
The multimodal intervention consists of:
- medication: Participants receive 1µg Alfacalcidol and 500mg Calcium daily
- mobility program: strength, balance and gait training twice a week for one hour
- patient education: a single meeting with teaching lessons on risk factors for falling and modes of fall prevention followed by an evaluation of the individual fall risk and corresponding recommendations to reduce it
Type d'étude
Inscription (Anticipé)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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NRW
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Herne, NRW, Allemagne, 44627
- Klinik für Altersmedizin und Frührehabilitation, Marienhospital, Ruhr-Universität Bochum
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Men and women who are 65 years of age or older
- Personal history of at least one movement-related, non-syncopal fall, either within the past year OR earlier with additional findings of an increased fall risk during screening examination.
- Creatinine-clearance of 30 to 60 ml/min equivalent to a moderately impaired kidney function (stage 3) according to the classification of the Kidney Disease Outcomes Quality Initiative (K/DOQI) of the National Kidney Foundation (NKF).
Exclusion Criteria:
- Immobility with inability to go out and participate in training course
- History of a fracture or of a stroke provided the event has occurred in the last 3 months
- Presence of a physical or mental disorder that has led to a set-up or to a planned set-up for a statutory care
- Severe dementia
- Severe disorder of speech or comprehension
- Disease that rules out participation during the intervention period or that would deteriorate as a result of type of intervention (e.g. absorptive hypercalciuria, nephrocalcinosis, calcium containing renal calculi or hypophosphataemia)
- Hypersensitivity (allergy) to Alfacalcidol, groundnuts, groundnut oil or Soya
- Vitamin-D hypersensitivity or -intoxication
- Simultaneous intake of vitamin D and its derivatives.
- Participation in any other clinical trial, that is still ongoing or has been completed less than 3 months prior date of intended inclusion
- Substitution of more than 500 mg calcium per day
- Planned medical therapy during the period of intervention that requires long-term suspension of intervention.
- Presence of hypercapnia of over 2.6mmol/l, calcium x phosphate product of over 3.7 (mmol/l)2 and alkalosis with venous blood-pH- reading of over 7.44 (milk-alkali-syndrome, Burnett syndrome)
- Hypercalcaemia (e.g. as a result of hyperparathyroidism, an overdose of vitamin D, paraneoplastic syndrome, osseous metastases, sarcoidosis, Boeck´s disease, osteoporosis induced by immobilisation) or hypermagnesemia according to normative values of the engaged laboratory
- Hereditary fructose intolerance
- Commitment into an institution
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Number of fallers
Délai: One year
|
One year
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Number of falls
Délai: One year
|
One year
|
Number of fractures
Délai: One year
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One year
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Performance in balance and mobility
Délai: One year
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One year
|
Fear of falling
Délai: One year
|
One year
|
Rate of hypercalcaemia
Délai: One year
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One year
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Prof. Dr. med. Ludger Pientka, MD, MPH, Klinik für Altersmedizin und Frührehabilitation, Marienhospital Herne, Ruhr-Universität Bochum
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GER-001-SP
- EudraCT 2006-006205-83
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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