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SNCTP000004426 | ISRCTN12051706 | BASEC2021-00601

Mobilise-D Studie: Messung von Mobilität mit Bewegungssensoren

Data source: BASEC (Imported from 03.05.2024), WHO (Imported from 03.05.2024)
Changed: Dec 23, 2023, 4:25 PM
Disease category: Respiratory diseases (non cancer)

Brief description of trial (Data source: BASEC)

Die Fähigkeit, zu gehen und sich zu bewegen, trägt wesentlich dazu bei, dass sich Menschen wohl und gesund fühlen. Heutzutage bieten kleine elektronische Geräte, sogenannte Bewegungssensoren, eine einfache Möglichkeit, die verschiedenen Aspekte der Mobilität zu erheben. Mit diesem Forschungsprojekt wollen wir herausfinden, welche Aspekte der Mobilität, die diese Bewegungssensoren messen, für Personen mit bestimmten chronischen Erkrankungen besonders relevant sind. Aus diesen Resultaten werden wir eine Methode (einen digitalen Algorithmus) entwickeln, der die relevante Mobilität möglichst genau beschreibt. Dieses Forschungsprojekt ist eine Kohortenstudie und Teil des Mobilise-D-Projekts (www.mobilise-d.eu). Mobilise-D ist ein von der EU finanziertes Projekt, das von über 34 europäischen Universitäten und Industriepartnern durchgeführt wird. In ganz Europa werden insgesamt 2‘400 Personen teilnehmen, die entweder an einer COPD, an Parkinson oder an multipler Sklerose leiden oder einen Oberschenkelhalsbruch erlitten haben. In der Schweiz werden in drei Rehabilitationskliniken Personen mit COPD für eine Teilnahme angefragt. Es ist geplant, insgesamt 40 Personen für das Forschungsprojekt einzuschliessen. Die Studienteilnehmenden werden über einem Zeitraum von zwei Jahren zu fünf Studienbesuchen einladen. Die Erhebungen bei diesen Besuchen umfassen das Ausfüllen von Fragebögen, die Beantwortung von Fragen sowie die Durchführung von verschiedenen Tests und klinischen Untersuchungen. Im Anschluss tragen die Studienteilnehmenden neun Tage lang einen Bewegungssensor und werden gebeten, zu Hause ein Tagebuch zur Verschlechterung von allfälligen Lungensymptomen zu führen.

Health conditions investigated(Data source: BASEC)

In dieser Studie werden Personen untersucht, die entweder an einer COPD, an Parkinson oder an multipler Sklerose leiden oder einen Oberschenkelhalsbruch erlitten haben.

Health conditions (Data source: WHO)

Parkinson’s disease (PD), multiple sclerosis (MS), chronic obstructive pulmonary disease (COPD), proximal femoral fracture (PFF)
Not Applicable
Parkinson disease, multiple sclerosis, other chronic obstructive pulmonary disease, fracture of femur

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Validierung von digitalen Mobilitäts-Outcomes ("digital mobility outcomes") bei Personen die an COPD, Parkinson, multipler Sklerose oder einem Oberschenkelhalsbruch leiden.

Interventions (Data source: WHO)


Participants will attend a baseline visit and four follow up visits every 6 months (study length is 24 months). Each visit will involve the completion of questionnaires and assessments including:
1. Descriptive measures (i.e. height and weight, living arrangements, smoking and alcohol use and vision)
2. Clinical assessments (i.e. level of function and disability, quality of life, frailty, fall and injury history, medical history, medication, blood pressure, pain, fatigue and muscle/fat mass)
3. Psychological assessments (i.e. brief memory test, fear of falling and depression)
4. Physical assessments (i.e. balance tests, 6-minute walk test and muscle strength)
5. Disease-specific assessments measuring the severity of the participant s health condition
At the end of each visit, participants will be asked to wear a mobility monitor around their waist for 7 days. The monitor will measure several aspects of mobility such as walking speed and step length.

Criteria for participation in trial (Data source: BASEC)

- Erwachsene Person (mind. 18 Jahre) mit genügend Deutschkenntnissen zum Verständnis der Studienprozesse
- COPD Diagnose
- Stabiler klinischer Zustand

Exclusion criteria (Data source: BASEC)

- Spezifisch definierte medizinische Vorfälle innerhalb der letzten 3 Monaten
- Geplante Lungentransplantation
- Aktuelle Diagnose von Lungenkrebs

Inclusion/Exclusion Criteria (Data source: WHO)

Inclusion criteria: All participants: 1. Adults aged 18 or over 2. Able to walk 4 meters independently with or without walking aids 3. Anticipated availability for repeated study visits over 24 months 4. Ability to consent and comply with any study specific procedures. 5. Willingness to wear the McRobert’s body sensor (DynaPort MoveMonitor) 6. Able to read and write in first language in the respective country PD Cohort: 1. Patients with the clinical diagnosis of PD according to the recent criteria of the Movement Disorder Society 2. Hoehn & Yahr stage I-III. MS Cohort: 1. A diagnosis of MS based on the revised McDonald’s criteria 2. EDSS score of 3.0-6.5. 3. Evidence of confirmed disability progression within the 12 months prior to screening (defined by a 6-month confirmed EDSS increase of 1.0-point for participants if the EDSS score was 3.0 to 5.5 and a 0.5-point if the EDSS score was 6.0 to 6.5). COPD Cohort: 1. Diagnosis of COPD (post-bronchodilator forced expiratory volume in the first second (FEV1) to forced vital capacity (FVC) ratio
Minimum age:
Maximum age:
Sex: Both
Exclusion criteria: All participants: 1. Occurrence of any of the following within 3 months prior to informed consent: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac resynchronization therapy device (CRTD), active treatment for cancer or other malignant disease, uncontrolled congestive heart disease (NYHA class >3), acute psychosis or major psychiatric disorders or continued substance abuse. PD Cohort: 1. History consistent with Dementia with Lewy Bodies (DLB), atypical parkinsonian syndromes (including multiple system atrophy or progressive supranuclear palsy, diagnosed according to accepted criteria) 2. Repeated strokes or stepwise progression of symptoms, leading to a diagnosis of ‘vascular parkinsonism’ 3. Drug-induced Parkinsonism MS Cohort: 1. Clinical relapse within 30 days prior to screening and baseline. COPD Cohort: 1. Having undergone major lung surgery (e.g. lung transplant) 2. Current diagnosis of lung cancer 3. Primary respiratory diseases other than COPD 4. Substantial limitations in mobility due to factors other than COPD 5. Lung volume reduction within 6 months before inclusion PFF Cohort: 1. Not able to walk before treatment of hip fracture

Further information on the trial in WHO primary registry

http://www.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN12051706

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=ISRCTN12051706
Further information on trial

Date trial registered

Dec 10, 2020

Incorporation of the first participant

Apr 12, 2021

Recruitment status

Recruiting

Academic title (Data source: WHO)

Validating digital mobility assessment using wearable technology – the Mobilise-D Clinical Validation study

Type of trial (Data source: WHO)

Observational

Design of the trial (Data source: WHO)

Observational non-interventional study (Other)

Phase (Data source: WHO)

Not Applicable

Primary end point (Data source: WHO)

Global primary outcome:
Change in the functional component score of the Late-Life Functional Disability Index (LLFDI) during 24-month follow-up, measured at baseline, 6, 12, 18 and 24 months

There are also disease-specific primary outcomes for each cohort:
1. PD Cohort: Fall frequency during 24 months follow-up, collected via face-to-face interview, participant-completed falls diaries and hospital records at baseline, 6, 12, 18 and 24 months
2. MS Cohort: Fall frequency during 24 months follow-up, collected via face-to-face interview, participant-completed falls diaries and hospital records at baseline, 6, 12, 18 and 24 months
3. COPD Cohort: Occurrence of moderate-to-severe COPD exacerbations during the first 12 months of follow-up, collected via face-to-face interview, participant-completed falls diaries and hospital records at baseline, 6 and 12 months
4. PFF Cohort: Admission to a care home assessed from patient records at 6 months follow-up

Secundary end point (Data source: WHO)

There are no secondary outcome measures

Contact information (Data source: WHO)

Innovative Medicines Initiative 2 Joint Understanding under grant agreement No 820820

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Aarau, Bern, Zurich

Countries (Data source: WHO)

Belgium, France, Germany, Israel, Italy, Norway, Spain, Switzerland, United Kingdom

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

PD Dr. Anja Frei
+41 44 634 43 60
anja.frei@uzh.ch

Contact for scientific information (Data source: WHO)

Isabel
Neatrour
Mobilise-D Office Room 3.27 The Catalyst 3 Science Square Newcastle Helix Newcastle upon Tyne United Kingdom
+44 (0)191 2081406
isabel.neatrour@newcastle.ac.uk

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Zürich

Date of authorisation by the ethics committee

28.10.2021

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2021-00601

Secondary ID (Data source: WHO)

IRAS 289543
Nil known
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