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

NCT06600438 | Not Yet Recruiting

• 1 other identifier: 362207
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hyposmia; Anosmia; Olfactory Dysfunction

Keywords

Hyposmia; Physical activity; Feasibility randomized controlled trial; Wearable technology; Smartphone application; Olfactory dysfunction; Digital health intervention

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (weeks 0-4) to 18 months (weeks 75-78)

• 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).

  Throughout the 18-month study period, with summaries at 9 months and 18 months

Secondary Outcomes (20)

• Change in Moderate-to-Vigorous Physical Activity (MVPA) Intensity

  Baseline (weeks 0-4) to 9 months and 18 months

• Cardiorespiratory Fitness: Estimated VO₂max

  Continuously throughout the 18-month study period, with summaries at baseline, 9 months, and 18 months

• Blood Pressure

  Baseline and 18 months (in-person visits)

• Remote Digital Motor Assessment: Roche Mobile Application V2

  Every 6 weeks from randomisation to 18 months (approximately 13 assessment windows)

• Structured Motor Examination: MDS-UPDRS Part III, Functional Gait Assessment, and Mini-BESTest

  Baseline and 18 months (in-person visits)

Study Arms (2)

100% exercise increase

EXPERIMENTAL

Arm: Full-Dose Exercise Group Participants in this arm will be asked to increase their average daily step count by 100% compared with baseline. Using a Fitbit smartwatch and the Slow-SPEED smartphone app, they will receive personalised step goals, real-time feedback, and gamified challenges to encourage gradual and sustained increases in physical activity. The programme is delivered remotely and unsupervised over 18 months, with progress monitored continuously through the wearable device.

Other: Slow-SPEED app

10% exercise increase

ACTIVE COMPARATOR

Arm: Low-Dose Control Group Participants in this arm will be asked to increase their average daily step count by 10% compared with baseline. Like the intervention group, they will use a Fitbit smartwatch and the Slow-SPEED smartphone app, receiving similar gamified feedback and motivational tools. The lower step target provides an active control condition while maintaining blinding. The programme is delivered remotely and unsupervised over 18 months, with continuous monitoring via the wearable device.

Other: Slow-SPEED app

Interventions

Slow-SPEED app OTHER

Gamified motivational smartphone app

10% exercise increase; 100% exercise increase

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Queen Mary University of London: lead
• Radboud University Medical Center: collaborator

Related Publications (12)

• Doty RL, Shaman P, Dann M. Development of the University of Pennsylvania Smell Identification Test: a standardized microencapsulated test of olfactory function. Physiol Behav. 1984 Mar;32(3):489-502. doi: 10.1016/0031-9384(84)90269-5.

  PMID: 6463130 BACKGROUND

• Patel ZM, Holbrook EH, Turner JH, Adappa ND, Albers MW, Altundag A, Appenzeller S, Costanzo RM, Croy I, Davis GE, Dehgani-Mobaraki P, Doty RL, Duffy VB, Goldstein BJ, Gudis DA, Haehner A, Higgins TS, Hopkins C, Huart C, Hummel T, Jitaroon K, Kern RC, Khanwalkar AR, Kobayashi M, Kondo K, Lane AP, Lechner M, Leopold DA, Levy JM, Marmura MJ, Mclelland L, Miwa T, Moberg PJ, Mueller CA, Nigwekar SU, O'Brien EK, Paunescu TG, Pellegrino R, Philpott C, Pinto JM, Reiter ER, Roalf DR, Rowan NR, Schlosser RJ, Schwob J, Seiden AM, Smith TL, Soler ZM, Sowerby L, Tan BK, Thamboo A, Wrobel B, Yan CH. International consensus statement on allergy and rhinology: Olfaction. Int Forum Allergy Rhinol. 2022 Apr;12(4):327-680. doi: 10.1002/alr.22929.

  PMID: 35373533 BACKGROUND

• Yuan Y, Chamberlin KW, Li C, Luo Z, Simonsick EM, Kucharska-Newton A, Chen H. Olfaction and Mobility in Older Adults. JAMA Otolaryngol Head Neck Surg. 2024 Mar 1;150(3):201-208. doi: 10.1001/jamaoto.2023.4375.

  PMID: 38236595 BACKGROUND

• Yeo BSY, Chan JH, Tan BKJ, Liu X, Tay L, Teo NWY, Charn TC. Olfactory Impairment and Frailty: A Systematic Review and Meta-Analysis. JAMA Otolaryngol Head Neck Surg. 2024 Sep 1;150(9):772-783. doi: 10.1001/jamaoto.2024.1854.

  PMID: 38990553 BACKGROUND

• Paluch AE, Bajpai S, Bassett DR, Carnethon MR, Ekelund U, Evenson KR, Galuska DA, Jefferis BJ, Kraus WE, Lee IM, Matthews CE, Omura JD, Patel AV, Pieper CF, Rees-Punia E, Dallmeier D, Klenk J, Whincup PH, Dooley EE, Pettee Gabriel K, Palta P, Pompeii LA, Chernofsky A, Larson MG, Vasan RS, Spartano N, Ballin M, Nordstrom P, Nordstrom A, Anderssen SA, Hansen BH, Cochrane JA, Dwyer T, Wang J, Ferrucci L, Liu F, Schrack J, Urbanek J, Saint-Maurice PF, Yamamoto N, Yoshitake Y, Newton RL Jr, Yang S, Shiroma EJ, Fulton JE; Steps for Health Collaborative. Daily steps and all-cause mortality: a meta-analysis of 15 international cohorts. Lancet Public Health. 2022 Mar;7(3):e219-e228. doi: 10.1016/S2468-2667(21)00302-9.

  PMID: 35247352 BACKGROUND

• Johnston W, Judice PB, Molina Garcia P, Muhlen JM, Lykke Skovgaard E, Stang J, Schumann M, Cheng S, Bloch W, Brond JC, Ekelund U, Grontved A, Caulfield B, Ortega FB, Sardinha LB. Recommendations for determining the validity of consumer wearable and smartphone step count: expert statement and checklist of the INTERLIVE network. Br J Sports Med. 2021 Jul;55(14):780-793. doi: 10.1136/bjsports-2020-103147. Epub 2020 Dec 24.

  PMID: 33361276 BACKGROUND

• Noyce AJ, R'Bibo L, Peress L, Bestwick JP, Adams-Carr KL, Mencacci NE, Hawkes CH, Masters JM, Wood N, Hardy J, Giovannoni G, Lees AJ, Schrag A. PREDICT-PD: An online approach to prospectively identify risk indicators of Parkinson's disease. Mov Disord. 2017 Feb;32(2):219-226. doi: 10.1002/mds.26898. Epub 2017 Jan 16.

  PMID: 28090684 BACKGROUND

• Yuan Y, Li C, Luo Z, Simonsick EM, Shiroma EJ, Chen H. Olfaction and Physical Functioning in Older Adults: A Longitudinal Study. J Gerontol A Biol Sci Med Sci. 2022 Aug 12;77(8):1612-1619. doi: 10.1093/gerona/glab233.

  PMID: 34379770 BACKGROUND

• Oleszkiewicz A, Croy I, Hummel T. The impact of olfactory loss on quality of life: a 2025 review. Chem Senses. 2025 Jan 22;50:bjaf023. doi: 10.1093/chemse/bjaf023.

  PMID: 40719006 BACKGROUND

• Brickwood KJ, Watson G, O'Brien J, Williams AD. Consumer-Based Wearable Activity Trackers Increase Physical Activity Participation: Systematic Review and Meta-Analysis. JMIR Mhealth Uhealth. 2019 Apr 12;7(4):e11819. doi: 10.2196/11819.

  PMID: 30977740 BACKGROUND

• Lipsmeier F, Taylor KI, Postuma RB, Volkova-Volkmar E, Kilchenmann T, Mollenhauer B, Bamdadian A, Popp WL, Cheng WY, Zhang YP, Wolf D, Schjodt-Eriksen J, Boulay A, Svoboda H, Zago W, Pagano G, Lindemann M. Reliability and validity of the Roche PD Mobile Application for remote monitoring of early Parkinson's disease. Sci Rep. 2022 Jul 15;12(1):12081. doi: 10.1038/s41598-022-15874-4.

  PMID: 35840753 BACKGROUND

• Li R, Li Y, Wang L, Li L, Fu C, Hu D, Wei Q. Wearable Activity Tracker-Based Interventions for Physical Activity, Body Composition, and Physical Function Among Community-Dwelling Older Adults: Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Med Internet Res. 2025 Apr 3;27:e59507. doi: 10.2196/59507.

  PMID: 40179387 BACKGROUND

Related Links

• Slow-SPEED-UK participants will be identified via PREDICT-PD.
• Slow-SPEED UK participants will be identified via the The Smell \& Taste Clinic ENT Department James Paget University Hospital NHS Foundation Trust via collaborator: Professor Carl Philpott, Gorleston, Great Yarmouth Norfolk, NR31 6LA
• Slow-SPEED International (including Slow-SPEED UK site) LinkedIn profile

MeSH Terms

Conditions

Anosmia; Motor Activity

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Alastair J Noyce, BMedSci, MBBS, MSc, MRCP, PhD

  Centre for Preventive Neurology, Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viktoria Azoidou, PhD, MSc, BSc

CONTACT

0207 882 3850; v.azoidou@qmul.ac.uk

Alastair J Noyce, BMedSci, MBBS, MSc, MRCP, PhD

CONTACT

0207 882 3850; a.noyce@qmul.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding is maintained by presenting all activity goals within the Slow-SPEED smartphone application as relative percentage targets rather than absolute step values. Everyone involved remains unaware of group allocation throughout the 18-month study period. The use of an active control arm receiving a minimum activity target through the same digital platform, with identical application structure, contact frequency, and user experience across both arms, further supports blinding by minimising differences in participant experience between groups. Allocation concealment is achieved through sequentially numbered, opaque, sealed envelopes. To assess the integrity of blinding, participants will be asked at study completion to indicate which group they believe they were allocated to.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The primary purpose is to evaluate feasibility, acceptability, and safety of delivering the Slow-SPEED intervention.

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: September 19, 2024
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share