Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands

NCT06193252 | Recruiting

• 1 other identifier: NL84072.091.23
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the feasibility if a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in patients with isolated Rapid Eye Movement (REM) sleep behaviour disorder over a long period of time (24 months). Participants will be tasked to achieve an incremental increase of daily steps (volume) and amount of minutes exercised at a certain heart rate (intensity) with respect to their own baseline level. Motivation with regards to physical activity will entirely be communicated through the study specific Slow Speed smartphone app. Primary outcomes will be compliance expressed as longitudinal change in digital measures of physical activity (step count) measured using a Fitbit smartwatch. Exploratory outcomes entail retention rate, completeness of remote digital biomarker assessments, digital prodromal motor and non-motor features of PD, blood biomarkers and brain imaging markers. Using these biomarkers, we aim to develop a composite score (prodromal load score) to estimate the total prodromal load. An international exercise study with fellow researchers in the United States and United Kingdom are currently in preparation (Slow-SPEED). Our intention is to analyse overlapping outcomes combined where possible through a meta-analysis plan, to obtain insight on (determinants of) heterogeneity in compliance and possible efficacy across subgroups

Conditions

Parkinson Disease; Prodromal Stage; Neurodegenerative Diseases; Parkinsonian Disorders; REM Sleep Behavior Disorder; Basal Ganglia Diseases; Central Nervous System Diseases; Synucleinopathies; Nervous System Diseases; Cerebral Disorder; Brain Diseases

Keywords

Physical Activity; Prevention; Remote; Mobile Health (mHealth); Feasibility; Exercise; Digital biomarker; Blood; Imaging; MRI; Motivational application; Walking; Parkinson Disease; Prodromal

Outcome Measures

Primary Outcomes (1)

• Mean change in step count per day

  Mean change in step count per day as measured continuously with a smartwatch. Mean steps per day will be calculated from 4-week periods. Higher positive change in step count indicate more volume of physical activity.

  All 4 week periods between and including week -4 until 0 (baseline period) and week 100 until 104 (follow-up period)

Secondary Outcomes (44)

• Change in moderate to vigorous physical activity (MVPA) per day

  All 4 week periods between and including week -4 until 0 (baseline period) and week 100 until 104 (follow-up period)

• Change in resting heart rate (physical fitness)

  All 4 week periods between and including week -4 until 0 (baseline period) and week 100 until 104 (follow-up period)

• Change in heart rate variability (physical fitness)

  All 4 week periods between and including week -4 until 0 (baseline period) and week 100 until 104 (follow-up period)

• Change in blood pressure (physical fitness)

  Week 0 (baseline) and week 104 (follow-up)

• Change in VO2max (physical fitness)

  All 4 week periods between and including week -4 until 0 (baseline period) and week 100 until 104 (follow-up period)

Study Arms (2)

Intervention

EXPERIMENTAL

Large proportional increase in step count and minutes exerting moderate to vigorous physical activity (MVPA) relative to baseline level.

Behavioral: Increase of physical activity volume and intensity with the use of a motivational smartphone application

Active control

ACTIVE COMPARATOR

Small proportional increase in step count and minute exerting moderate to vigorous physical activity (MVPA) relative to baseline level.

Behavioral: Increase of physical activity volume and intensity with the use of a motivational smartphone application

Interventions

Increase of physical activity volume and intensity with the use of a motivational smartphone application BEHAVIORAL

A motivational smartphone application will be available for all participants using their own smartphone: the Slow-SPEED app. The Slow-SPEED app will motivate participants to increase the volume and intensity of their physical activity in daily life over a long period of time (2 years) based on their own baseline levels. Different treatment arms will receive different physical activity goals. The app offers participants feedback and support, that will stimulate them to reach their individual physical activity goal (i.e. incremental relative increase of step count and minutes exerting ≥ 64% of maximum heart rate reflecting MVPA relative to baseline level.).

Active control; Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• previously diagnosed with iRBD meeting the following criteria according to the International Classification of Sleep Disorders (ICSD-3)
• able to understand the Dutch language
• being able to walk independently inside the home without the use of a walking aid
• Not in a high physical activity range during the 4-week eligibility and baseline period
• in possession of a suitable smartphone compatible with the Slow-SPEED app, the Fitbit app and the Roche PD Research Mobile application.

You may not qualify if:

• clinically diagnosed or self-reported diagnosis neurodegenerative disease;
• self-reported weekly falls in the previous 3 months;
• dexterity problems or cognitive impairments hampering smartphone use;
• if they do not wish to be informed about an increased risk of developing diseases associated with iRBD
• if individual is not community-dwelling
• history of epilepsy, structural brain abnormalities (i.e. stroke, traumatic defects, large arachnoid cysts) or brain surgery
• claustrophobia
• implanted electrical devices (i.e. pacemaker, deep-brain stimulator (DBS), neurostimulator)
• metal implants (such as prosthetics, ossicle prosthesis, metal plates or other non-removable metal part) or metal splinters
• pregnancy
• fear for incidental finding

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Stichting ParkinsonNL: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Michael J. Fox Foundation for Parkinson's Research: collaborator
• Parkinson's UK: collaborator
• Cure Parkinson's: collaborator
• Edmond J. Safra Foundation: collaborator
• Davis Phinney Foundation: collaborator
• Donders Centre for Cognitive Neuroimaging: collaborator
• Anne Wojcicki Foundation: collaborator
• Sleep Medicine Centre Kempenhaeghe: collaborator
• Sleep Medicine Centre SEIN: collaborator
• Queen Mary University of London: collaborator
• 23andMe, Inc.: collaborator
• Parkinsons Progression Markers Initiative (PPMI): collaborator
• Massachusetts General Hospital: collaborator
• Harvard School of Public Health (HSPH): collaborator
• IJsfontein B.V., Netherlands: collaborator
• Hoffmann-La Roche: collaborator
• Erasmus Medical Center: collaborator
• University of Illinois at Chicago: collaborator
• University of Rochester: collaborator
• University of Bristol: collaborator
• University of Plymouth: collaborator
• University of Luebeck: collaborator
• McGill University: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Prodromal Symptoms; Neurodegenerative Diseases; Parkinsonian Disorders; REM Sleep Behavior Disorder; Basal Ganglia Diseases; Central Nervous System Diseases; Synucleinopathies; Nervous System Diseases; Brain Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Movement Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Mental Disorders; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Sirwan KL Darweesh, PhD

  Radboudumc Department of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Oosterhof, MSc

CONTACT

0031631647857; thomas.oosterhof@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind randomized controlled trial

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: January 15, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: We will make relevant anonymised data available in a database after publication of the main results of our trial.
• Access Criteria: Researchers who are interested in re-use of the data are asked to contact the central contact person for permission.

Locations

NL (1)