RecruitingNot ApplicableNCT06600438

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

Slow-SPEED-United Kingdom: A Double-Blind Randomised Feasibility Trial of a Remote Gamified Physical Activity Programme in Adults With Hyposmia.

Sponsor

Queen Mary University of London

Enrollment

110 participants

Start Date

May 27, 2026

Study Type

INTERVENTIONAL

Conditions

Olfactory Dysfunction Anosmia Hyposmia

Summary

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

Min Age: 40 YearsMax Age: 100 Years

Inclusion Criteria7

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.
Willingness and ability to attend baseline (in-person), 9-month (remote), and 18-month (in-person) assessments.
Access to telephone or internet for interim communication. Specifically, in possession of a suitable smartphone (screen size minimum 4.6 inch; Android version 9 or iOS version 15 or newer).
Physical activity threshold: During the 4-week eligibility run-in, the mean daily step count must be <7,000 steps/day, calculated over ≥21 valid days (a valid day = ≥10 hours wear time or ≥1,000 steps). If recruitment after the first 2 months is <60-70% of target, and subject to TSC/Sponsor approval and REC amendment, eligibility may be broadened to <10,000 steps/day (i.e. participants averaging 7,000-9,999 steps/day become eligible).

Exclusion Criteria9

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).
Inability to complete study procedures in English, per investigator assessment
Unable to give consent
Participants not living independently in the community. Participants in nursing homes, hospitalised persons on in a non-institutionalised setting are excluded.
Subject's personal smartphone is Fitbit-incompatible i.e. Huawei P8 Lite; Huawei P9 Lite; Xiaomi Mi 6; Huawei P20 Lite
Activity level above threshold during eligibility run-in: mean daily step count ≥7,000 steps/day (or ≥10,000 steps/day if the broadened threshold is activated).