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Slow-SPEED UK: A Double-Blind Randomised Feasibility Trial

Study acronym: Slow-SPEED
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of May 1, 2026 to May 27, 2026
    v5
  2. Start date: Dec 1, 2025 to May 1, 2026v4 Show 6 more changesShow less
    • Primary endpoints: 1 to 2
    • Primary and study completion dates: Jul 31, 2027 to Oct 31, 2027
    • Secondary endpoints: 10 to 20
    • Study description expanded, about 42 words
    • Publications: 1 to 13
    • Study title revised
  3. Phase: Early Phase 1 to Not applicablev3 Show 9 more changesShow less
    • Trial status: Withdrawn to Not Yet Recruiting
    • Primary and study completion dates: Jul 1, 2029 to Jul 31, 2027
    • Start date: Jan 1, 2025 to Dec 1, 2025
    • Primary endpoint revised
    • Enrollment target: 0 to 110
    • Interventions: Slow-SPEED app (Device) to Slow-SPEED app (Other)
    • Eligibility criteria shortened, about 50 words
    • Secondary endpoints: 30 to 10
    • Study description shortened, about 14 words
  4. Trial status: Not Yet Recruiting to Withdrawn Sponsor's reason: Pause in application
    • Enrollment target: estimated 300 to confirmed 0
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06600438
Lead Sponsor Queen Mary University of London
Collaborators: Radboud University Medical Center
Conditions
(from sponsor)		 Hyposmia, Olfactory Dysfunction, Anosmia
Related terms Anosmia, Motor Activity
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov