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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Zurich, Schweiz, 8037
- Centre on Aging and Mobility, University of Zurich, Waid City Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Age 65+ years
- Diagnosed with MCI or mild dementia by the memory clinic of City Hospital Waid
Exclusion Criteria:
-
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
Andere Namen:
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.
|
|
Experimental: 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.
Andere Namen:
The home exercise program is a strengthening program that will consist of five simple exercises.
|
|
Sonstiges: 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.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Rate of falls (any falls, low trauma falls, injurious falls) during 12 month follow-up
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of participants who fell at least once during 12 months of follow up
Zeitfenster: 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)
Zeitfenster: Baseline, 6 & 12 months
|
assessed by a GAITRite analysis system
|
Baseline, 6 & 12 months
|
|
Cognitive function
Zeitfenster: Baseline, 6 & 12 months
|
assessed using the Montreal Cognitive Assessment (MoCA)
|
Baseline, 6 & 12 months
|
|
Alertness
Zeitfenster: 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
Zeitfenster: Baseline, 6 and 12 months
|
evaluated using the SF-36 questionnaire
|
Baseline, 6 and 12 months
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
progression of MCI/mild dementia
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Heike Bischoff-Ferrari, Prof., Director Geriatric Clinic University Hospital Zurich and Centre on Aging and Mobility, University of Zurich
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Psychische Störungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Neurokognitive Störungen
- Kognitionsstörungen
- Demenz
- Kognitive Dysfunktion
- Physiologische Wirkungen von Arzneimitteln
- Mikronährstoffe
- Vitamine
- Mittel zur Erhaltung der Knochendichte
- Calciumregulierende Hormone und Wirkstoffe
- Vitamin-D
- Cholecalciferol
Andere Studien-ID-Nummern
- SNCTP000000580
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .