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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Slow-SPEED app
Other interventionGamified motivational smartphone app
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: 100% exercise increaseExperimental treatment 1 intervention
Group B: 10% exercise increaseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Average Daily Step Count
Change in average daily step count from baseline (weeks 0-4) to the final four weeks of the 18-month study period (approximately weeks 75-78), measured continuously using the Fitbit Charge 6 wearable activity monitor. Average daily step count will be calculated across four-week periods and analysed descriptively as a measure of engagement and sustainability in keeping with the feasibility aims of the study.
Time frame
Baseline (weeks 0-4) to 18 months (weeks 75-78)2
Feasibility of Study Delivery
Composite feasibility outcome assessed by: (1) proportion of eligible participants who consent to take part (recruitment rate); (2) proportion of randomised participants who complete the 18-month study period (retention); (3) adherence to the intervention, measured by app engagement metrics and Fitbit wear time; (4) completeness of remote and in-person assessment data; and (5) frequency and nature of adverse events (safety).
Time frame
Throughout the 18-month study period, with summaries at 9 months and 18 monthsSecondary outcomes
1
Change in Moderate-to-Vigorous Physical Activity (MVPA) Intensity
Change in mean daily minutes spent at or above 64% of age-predicted maximum heart rate (HRmax), measured continuously via the Fitbit Charge 6 photoplethysmography sensor. Distribution of time across intensity bands will be described and the feasibility of capturing sustained heart-rate data over 18 months will be assessed. Analyses are exploratory only.
Time frame
Baseline (weeks 0-4) to 9 months and 18 months2
Cardiorespiratory Fitness: Estimated VO₂max
Feasibility of obtaining a remote estimate of aerobic fitness (VO₂max) via the Fitbit algorithm throughout the study period. Analyses will focus on completion rates, participant tolerance, and signal stability of remote VO₂max estimation. Resting heart rate and heart rate variability (HRV) will also be summarised as the average daily resting values to assess feasibility and stability of remote cardiovascular monitoring.
Time frame
Continuously throughout the 18-month study period, with summaries at baseline, 9 months, and 18 months3
Blood Pressure
Feasibility of repeated blood pressure measurement using standard sphygmomanometry, assessed at baseline and 18-month in-person visits. Supine and standing readings will be taken in accordance with American Autonomic Society recommendations to assess orthostatic hypotension. Collected for safety monitoring and feasibility assessment only; not used for clinical diagnosis.
Time frame
Baseline and 18 months (in-person visits)4
Remote Digital Motor Assessment: Roche Mobile Application V2
Feasibility of repeated remote motor task completion using the Roche Mobile Application V2 smartphone platform. Active tasks include finger tapping, shape drawing, reaction time, information processing, executive functioning, balance, gait, and upper limb performance, administered every 6 weeks throughout the study period. Feasibility assessed by number of data points received, proportion of expected submissions completed, and drop-off patterns across predefined 6-week windows from 0 to 78 weeks.
Time frame
Every 6 weeks from randomisation to 18 months (approximately 13 assessment windows)Sponsors and contacts
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Queen Mary University of London
Lead sponsor
Radboud University Medical Center
Collaborator
Source ClinicalTrials.gov