Slow-SPEED UK: A Double-Blind Randomised Feasibility Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-100
SponsorQueen Mary University of London
About this trial
Slow-SPEED UK is an 18-month randomised, double-blind feasibility trial evaluating the delivery, adherence, and acceptability of a digitally supported physical activity programme in community-dwelling adults aged 40 and over with objectively confirmed hyposmia (reduced sense of smell) and low baseline physical activity.
Participants are randomly assigned 1:1 to either a full-dose activity-support programme (targeting a 100% increase in daily step count) or a very low-dose active control (targeting a 10% increase). Both arms are delivered via a smartphone application linked to a wearable activity monitor (Fitbit Charge 6), with personalised weekly goals expressed as relative percentages to maintain blinding. The study is not designed to test clinical efficacy.
Eligibility criteria
Qualifiers
Age ≥ 40 years
Objective hyposmia, defined as scoring below the 15th percentile (adjusted for age/sex) on UPSIT
Ability and willingness to provide written informed consent
Proficiency in written and spoken English sufficient to complete study procedures.
Disqualifiers
Clinical diagnosis of PD, dementia, or other neurodegenerative conditions
Severe or unstable medical or psychiatric illness likely to impair participation
Use of agents known to alter olfaction (e.g. intranasal zinc, chronic corticosteroids)
Current enrolment in an interventional study within the past 3 months (standard research retention guidance).
Trial design
Treatments tested in this trial
- Slow-SPEED app
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Queen Mary University of London
Lead sponsor
Radboud University Medical Center
Collaborator
Source ClinicalTrials.gov