The primary objective is to determine the feasibility of a remote intervention study to promote physical activity in people with iRBD. The secondary objectives are to determine the longitudinal effect of an exercise intervention in people with iRBD…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the longitudinal change (from baseline to 2-year
follow-up) in number of steps between the treatment- and active control arm,
measured with the participants* smartphone and smartwatch.
Secondary outcome
Secondary outcomes will be longitudinal change in measures of physical fitness,
prodromal motor and non-motor features of PD, biological mediators for
prodromal disease progression (blood: neuroinflammation, neurodegeneration,
pathological protein spread, growth factors and ageing mechanisms, brain
imaging markers of global and region-specific atrophy and neuroplasticity).
Furthermore, we will assess completeness of remote digital biomarker
assessments in both groups combined and feasibility. We will explore the
incidence of clinically manifest PD in both treatment arms, acknowledging that
only few participants may reach this endpoint during this 2-year study.
Finally, we will conduct sensitivity analyses on gene specific mutations.
Background summary
Disease-slowing interventions have been ineffective in clinically manifest
Parkinson*s disease (PD), when pathology is already advanced, but could succeed
in prodromal PD, when pathology is limited. People with an isolated Rapid Eye
Movement (REM) sleep Behaviour Disorder People (iRBD) have a high risk to
develop clinically manifest PD or a related neurodegenerative disease and are
therefore considered to have probable prodromal PD. Here, we will study the
effect of physical activity on the prodromal course of Parkinson's disease.
Study objective
The primary objective is to determine the feasibility of a remote intervention
study to promote physical activity in people with iRBD. The secondary
objectives are to determine the longitudinal effect of an exercise intervention
in people with iRBD on digital, brain imaging and blood-based biomarkers of
physical fitness and prodromal PD.
Study design
Double-blind randomized controlled trial.
Intervention
Participants will be randomized into one of two groups. Both groups will be
encouraged to gradually increase the volume and intensity of their physical
activities. Volume will be measured with a smartphone and smartwatch as change
in step count relative to their own baseline step count (<7000). Intensity will
be measured as change in the amount of minutes in which > 64% heart rate of
their maximum heart rate is exerted relative to their own baseline count. The
target step count and intensity will be a large relative increase (by 100%) for
the intervention group (N=55). The active control group will get a target step
count and intensity with a small relative increase (by 10%) (N=55). Treatment
will be administered remotely using a gamified enhanced app.
Study burden and risks
The load on participants consists of the time spent on this project and two
research visits. The motivational smartphone application is non-invasive and
the risks associated with participation in this project are negligible. The
research visits will take place at baseline and after the intervention period
(2 years), consisting of physical examination, questionnaires, blood drawing
assessments at Radboudumc (once 6 ml; further six samples of total 53ml at each
assessment) and magnetic resonance brain imaging assessments at Donders Brain
Imaging Institute. The total time per visit is estimated to be 3 hours. Travel
expenses will be reimbursed. All other outcomes will be assessed remotely using
the participants* smartphone, a dedicated study smartwatch and digital
questionnaires. This involves passive monitoring of cardiorespiratory and
prodromal measures, as well as active assessments of prodromal motor features
(every 6 weeks) using the Roche PD mobile application v2. All measurements are
minimally burdensome and without nuclear radiation. Individual participants do
not directly benefit from participation, with the possible exception of
cardiovascular health benefits that may arise from increasing their physical
activity level. Disclosing information regarding the risk of developing PD may
cause distress. Only participants who are aware of this risk or wish to be
informed about risks related to iRBD will be included.
Reinier postlaan 4 route 914
Nijmegen 6525 GC
NL
Reinier postlaan 4 route 914
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
1) previously diagnosed with iRBD meeting the following criteria according to
the International Classification of Sleep Disorders (ICSD-3)59. Criteria A-D
must be met:
a. Repeated episodes of sleep related vocalization and/or complex motor
behaviours
b. These behaviours are documented by polysomnography to occur during REM sleep
or, based on clinical history of dream enactment, are presumed to occur during
REM sleep
c. Polysomnographic recording demonstrates REM sleep without atonia (RWA)
d. The disturbance is not explained more clearly by another sleep disorder,
mental disorder, medication, or substance use (the usage of beta-blockers or
anti-depressant as possible luxating factor is not excluded)
2) Aged 50 years or older
3) able to understand the Dutch language;
4) being able to walk independently inside the home without the use of a
walking aid.
5) equal to or less than 120 minutes of sports/outdoor activities per day
(question 5-28 LASA Physical Activity Questionnaire (LAPAQ))
6) less than an average 7,000 steps/day during the 4-week eligibility and
baseline period
7) In possession of a suitable smartphone (screen size minimum 4.6 inch),
(Android version 9 or iOS version 15 or newer)
Exclusion criteria
1) clinically diagnosed or self-reported diagnosis neurodegenerative disease;
2) self-reported weekly falls in the previous 3 months;
3) dexterity problems or cognitive impairments hampering smartphone
use;
4) if they do not wish to be informed about an increased risk of developing
diseases associated with iRBD
5) if individual is not community dwelling
Regarding the MRI brain-imaging:
6) history of epilepsy, structural brain abnormalities (i.e. stroke, traumatic
defects, large
archnoid cysts) or brain surgery
7) claustrophobia
8) implanted electrical devices (i.e. pacemaker, DBS, neurostimulator)
9) metal implants (such as prosthetics, ossicle prosthesis, metal plates or
other non-removable metal part)
10) pregnancy
11) any other exclusion as per Donders Centre for Cognitive Neuroimaging MRI
screening form
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84072.091.23 |