What is this study trying to find out about hyposmia?

This study is evaluating whether a digitally supported physical activity program is feasible, acceptable, and safe for adults aged 40 and over with a reduced sense of smell. It compares two levels of step count increase delivered via a smartphone app and wearable device. The research aims to inform future studies by assessing engagement and adherence over 18 months.

Who may be eligible for this hyposmia clinical trial?

Adults aged 40 to 100 years with confirmed reduced sense of smell and low baseline physical activity may be eligible. Participants must be able to use a compatible smartphone and commit to study assessments. People with Parkinson's disease, dementia, or taking medications affecting smell are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this hyposmia clinical trial?

Study-related care, including the study devices, app, and all trial visits, is provided at no cost. However, personal expenses like travel may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 40Years - 100Years

All Genders

ID06600438

Feasibility Study of a Remote Gamified Physical Activity Program Using Fitbit for Adults 40 and Older with Reduced Sense of Smell

Led by Queen Mary University of London · Updated on 2026-06-29

110

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research investigates the feasibility, acceptability, and safety of a digitally supported physical activity program for adults aged 40 and over with hyposmia, a reduced sense of smell, who have low baseline physical activity. The trial is an 18-month randomized, double-blind study comparing two levels of physical activity increases delivered via smartphone app and wearable activity tracker, focusing on engagement rather than clinical effectiveness. Participants are randomly assigned to one of two groups a full-dose exercise group aiming for a 100% increase in daily steps, or a low-dose control group targeting a 10% increase. Both groups use the Slow-SPEED smartphone app linked to a Fitbit Charge 6 device, which provides personalized, gamified weekly step goals expressed as relative percentages to keep the study blinded. The intervention is remote and unsupervised, with continuous activity monitoring over 18 months. Throughout the study, participants undergo assessments at baseline, 9 months, and 18 months, including olfactory testing, blood pressure, motor and cognitive evaluations, and various questionnaires related to physical activity, mood, sleep, and quality of life. Physical activity data is continuously recorded by Fitbit, with additional digital motor tasks and accelerometer measurements at specified intervals. The main outcome is the change in average daily step count from baseline to study end, alongside evaluation of feasibility factors like recruitment, retention, adherence, and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 100Years

All Genders

Eligibility Criteria

You may qualify if you...

Age 40 years or older
Confirmed reduced sense of smell scoring below the 15th percentile on a smell identification test
Ability and willingness to provide written informed consent
Proficiency in 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 a suitable smartphone (minimum 4.6-inch screen; Android 9 or iOS 15 or newer) and telephone or internet
Average daily step count less than 7,000 steps during a 4-week run-in period with at least 21 valid days (wear time ≥10 hours or ≥1,000 steps)
If recruitment is low, eligibility may include those with 7,000 to 9,999 steps per day

You will not qualify if you...

Clinical diagnosis of Parkinson's disease, dementia, or other neurodegenerative conditions
Severe or unstable medical or psychiatric illness likely to impair participation
Use of medications known to alter sense of smell (e.g., intranasal zinc, chronic corticosteroids)
Enrollment in another interventional study within the past 3 months
Inability to complete study procedures in English
Unable to give consent
Not living independently in the community (e.g., nursing homes, hospitalized non-institutionalized settings)
Use of a personal smartphone incompatible with Fitbit (e.g., Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, Huawei P20 Lite)
Average daily step count above eligibility threshold during run-in period

Your Study Journey

Screening

Duration - 4 weeks

Participants are screened for eligibility including smell testing, physical activity monitoring, and assessment of smartphone compatibility.

Initial telephone pre-screening and in-person smell test

Run-in Period

Duration - 4 weeks

Participants wear a Fitbit device to measure habitual daily step count over 4 weeks to confirm activity level eligibility.

Continuous activity monitoring via Fitbit

Treatment

Duration - 18 months

Participants use the Slow-SPEED smartphone app and Fitbit device to follow personalized step count goals, aiming for either a 100% or 10% increase in daily steps, with continuous monitoring and motivational features.

Continuous monitoring and remote support with assessments at baseline, 9 months, and 18 months

Assessment Visits

Duration - Throughout the 18-month study

Participants complete in-person and remote assessments including smell tests, motor and cognitive evaluations, questionnaires, and digital motor tasks at baseline, 9 months, and 18 months.

Baseline and 18-month in-person visits; 9-month remote visit