Move for Your Mind - Pilot Trial (MFYM - P)
Home Exercise, Vitamin D and Dalcroze Eurhythmics for Seniors With Mild Cognitive Impairment (MCI) or Mild Dementia
Move for your mind is a single blind, 3-arm randomized controlled clinical pilot trial. The study aims to test the effect of a weekly Dalcroze eurhythmics program (arm 1) and a home strength exercise program (arm 2) against control (no exercise) on the rate of falling, quality of life, gait performance and cognitive function. All groups receive vitamin D. In addition the study shall test the feasibility of the recruitment and the interventions in this target population.
The study includes 60 seniors, age 65 and older, with mild cognitive impairment or mild dementia. Participants are recruited by the memory clinic of City Hospital Waid.
During the 12 months follow-up, participants will have 3 clinical visits (baseline, 6 and 12 month). Despite major efforts the target population is very difficult to recruit and adherence to treatment is low. We therefore decided to stop recruitment and to use this trial as a pilot trial for future clinical trials of the same topic.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Primary objective To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) will decrease rate of falls in seniors with MCI or mild dementia compared with the control group.
Secondary objectives Objective 1: To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) decreases 12-month risk of falling at least once in seniors with MCI or mild dementia compared with the control group.
Objective 2: To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) improves cognitive func-tion and alertness in seniors with MCI or mild dementia compared with the control group.
Objective 3: To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) decreases gait variability in seniors with MCI or mild dementia compared with the control group.
Objective 4: To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) improves quality of life in seniors with MCI or mild dementia compared with the control group.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Zurich, Suisse, 8037
- Centre on Aging and Mobility, University of Zurich, Waid City Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age 65+ years
- Diagnosed with MCI or mild dementia by the memory clinic of City Hospital Waid
Exclusion Criteria:
-
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Jaques-Dalcroze eurhythmics
Jaques-Dalcroze eurhythmics (60min/wk) + 800 IU Vitamin D3
|
All participants receive a dose of 800 IU vitamin D3 per day as a standard of care.
800 IU Vitamin D is the dose that is currently recommended by the Swiss Health Department (Bundesamt für Gesundheit) for seniors over 60.
Autres noms:
The Jaques-Dalcroze eurhythmics method includes different courses of motion (multi-task exercises) that are conducted to the rhythm of improvised piano music.
A session starts with a short warm-up that includes simple exercises to get body and mind prepared for the rest of the exercise session.
The complexity of the exercises increases gradually during the session: starting with single tasks and then combining them into a multi-task exercise gradually increasing complexity.
|
|
Expérimental: Home exercise program
Home exercise strength program (3x30min/wk) + 800 IU vitamin D
|
All participants receive a dose of 800 IU vitamin D3 per day as a standard of care.
800 IU Vitamin D is the dose that is currently recommended by the Swiss Health Department (Bundesamt für Gesundheit) for seniors over 60.
Autres noms:
The home exercise program is a strengthening program that will consist of five simple exercises.
|
|
Autre: Vitamin D only
800 IU Vi-De 3
|
All participants receive a dose of 800 IU vitamin D3 per day as a standard of care.
800 IU Vitamin D is the dose that is currently recommended by the Swiss Health Department (Bundesamt für Gesundheit) for seniors over 60.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of falls (any falls, low trauma falls, injurious falls) during 12 month follow-up
Délai: at month 2, 4, 6, 8, 10 and 12 after baseline
|
A fall is defined as unintentional coming to rest on the ground, floor, or other lower level (coming to rest against furniture or a wall is not considered a fall).
All reported incident falls will be ascertained every 2 month (phone calls at 2, 4, 8 and 10 months and clinical visits at 6 and 12 months after baseline) with a questionnaire evaluating the circumstances of each fall and injuries associated with it.
Participants will also receive a diary to record any new health event including a fall.
The diary will serve as a supplementary tool to falls evaluation minimizing potential recall bias.
|
at month 2, 4, 6, 8, 10 and 12 after baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of participants who fell at least once during 12 months of follow up
Délai: at month 2, 4, 6, 8, 10 and 12 after baseline
|
at month 2, 4, 6, 8, 10 and 12 after baseline
|
|
|
Gait variability (stride time, stride length and gait speed)
Délai: Baseline, 6 & 12 months
|
assessed by a GAITRite analysis system
|
Baseline, 6 & 12 months
|
|
Cognitive function
Délai: Baseline, 6 & 12 months
|
assessed using the Montreal Cognitive Assessment (MoCA)
|
Baseline, 6 & 12 months
|
|
Alertness
Délai: Baseline, 6 & 12 months
|
Alertness will be assessed using the two subtests "alertness" and "split alertness" of the test of attentional performance (TAP)
|
Baseline, 6 & 12 months
|
|
Quality of life
Délai: Baseline, 6 and 12 months
|
evaluated using the SF-36 questionnaire
|
Baseline, 6 and 12 months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
progression of MCI/mild dementia
Délai: 6 &12 months
|
any progression of the cognitive disorder to a more severe state ( will be confirmed based on medical records of the memory clinic of Waid City Hospital.
Evaluation of this endpoint will be supported by information from the MoCA and the TAP subtests at baseline, 6, and 12 months clinical visits.
|
6 &12 months
|
|
Musculoskeletal pain
Délai: baseline, 6 and 12 month
|
assessed using McGill pain map.
Number of painful joints will be assessed using a joint map.
|
baseline, 6 and 12 month
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Heike Bischoff-Ferrari, Prof., Director Geriatric Clinic University Hospital Zurich and Centre on Aging and Mobility, University of Zurich
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- Les troubles mentaux
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Troubles neurocognitifs
- Troubles cognitifs
- Démence
- Dysfonctionnement cognitif
- Effets physiologiques des médicaments
- Micronutriments
- Vitamines
- Agents de conservation de la densité osseuse
- Hormones et agents régulateurs du calcium
- Vitamine D
- Cholécalciférol
Autres numéros d'identification d'étude
- SNCTP000000580
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 .