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Search / Trial NCT06600438

Slowing Parkinson's Early Through Exercise Dosage - United Kingdom

Launched by QUEEN MARY UNIVERSITY OF LONDON · Sep 13, 2024

Trial Information

Current as of July 21, 2025

Withdrawn

Keywords

Parkinson's Disease Parkinson Disease Anosmia Hyposmia Smell Loss Exercise Prevention

ClinConnect Summary

Slow-SPEED-UK is a randomised controlled trial investigating the effects of an app-based exercise programme in early/prodromal Parkinson's Disease (PD). The trial aims to recruit a total of 300 participants from the following cohorts: i) PD (diagnosed in previous 3 years), ii) smell loss or iii) REM-sleep behaviour disorder. Participants will be identified and recruited from a large, online, observational trial known as PREDICT-PD.

PREDICT-PD members meeting the inclusion/exclusion criteria will be contacted via email or telephone. The trial will be explained in detail, and written informa...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • In order to be eligible to participate Slow-SPEED-UK, a subject must meet the following criteria:
  • 1. Either:
  • Previously diagnosed with iRBD, meeting all of the following criteria, as per the International Classification of Sleep Disorders (ICSD-3):
  • 1. Repeated episodes of sleep related vocalization and/or complex motor behaviours
  • 2. 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
  • 3. Polysomnographic recording demonstrates REM sleep without atonia (RWA)
  • 4. 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)
  • OR:
  • Hyposmia, defined as olfaction less than or equal to the 15th percentile by age and sex, as determined by the University of Pennsylvania Smell Identification Test (UPSIT).
  • OR:
  • Idiopathic Parkinson's disease, diagnosed by a neurologist within the previous 3 years. Subjects must be at Hoehn and Yahr stage 1-3 at baseline.
  • 2. Aged 50 years or older
  • 3. Able to understand the English language
  • 4. Able to walk independently inside the home without the use of any form of walking aid
  • 5. Less than or equal to 120 minutes of sports/outdoor activities per day (question 1-22, 30 \& 31) on LASA Physical Activity Questionnaire (LAPAQ))
  • 6. Less than an average of 10,000 steps/day during the 4-week 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 of a neurodegenerative disease (other than PD).
  • 2. Self-reported weekly falls in the previous 3 months
  • 3. Dexterity problems or cognitive impairments hampering smartphone use
  • 4. Subject not wishing to be informed about the association between iRBD/hyposmia and risk of future diseases
  • 5. Care home residents or hospitalised persons.
  • 6. Subject's personal smartphone is Fitbit-incompatible i.e. Huawei P8 Lite; Huawei P9 Lite; Xiaomi Mi 6; Huawei P20 Lite
  • 7. Unable to give informed consent

About Queen Mary University Of London

Queen Mary University of London is a prestigious research-intensive institution recognized for its commitment to advancing medical science and improving health outcomes. As a leading sponsor of clinical trials, the university harnesses its academic excellence and innovative research capabilities to explore groundbreaking treatments and therapies across various medical disciplines. With a focus on collaboration, the institution engages with a diverse network of clinicians, researchers, and industry partners to ensure rigorous study design, ethical conduct, and the translation of research findings into clinical practice. Queen Mary University of London is dedicated to contributing to the global body of knowledge in healthcare through high-quality clinical research that prioritizes patient safety and welfare.

Locations

Patients applied

0 patients applied

Trial Officials

Alastair J Noyce, BMedSci, MBBS, MSc, MRCP, PhD

Principal Investigator

Centre for Preventive Neurology, Queen Mary University of London

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported