Slow-SPEED UK: A Double-Blind Feasibility Trial for a Digitally Supported Activity Program in Adults 40+ with Smell Loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Slow-SPEED UK is a feasibility study that randomizes adults 40 and older with objectively confirmed hyposmia and low activity to either a full-dose, digitally supported physical activity program or a very low-dose active control. Both groups use a smartphone app and a Fitbit Charge 6 to set weekly goals expressed as relative percent increases, with the aim of 100% vs 10% increases in daily steps. The trial is designed to assess feasibility, adherence, acceptability, and safety, not clinical efficacy or disease outcomes, over 18 months. Participants are identified through the PREDICT-PD platform or a smell and taste clinic, undergo UPSIT testing, run-in step monitoring, and randomization with stratification, under blind conditions for the intervention delivery. Eligibility requires age 40+, objective hyposmia, consent, English proficiency, and ability to attend specified assessments, with a run-in threshold of <7,000 steps/day (potentially broadened to <10,000 under certain conditions).

Why it matters

Who can join: the full rules

Inclusion criteria

* 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 criteria

* 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).

Where it's running

• Viktoria Azoidou
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Alastair J Noyce, BMedSci, MBBS, MSc, MRCP, PhD — Centre for Preventive Neurology, Queen Mary University of London
• Study coordinator: Viktoria Azoidou, PhD, MSc, BSc
• Email: v.azoidou@qmul.ac.uk
• Phone: 0207 882 3850

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.