One study, many treatments: a new way to fight muscle loss in later life

Randomised evaluation platform – Interventions to treat older people with sarcopenia

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10801475

Enrollment

Registered

2025-06-12

Start date

2025-07-31

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia Musculoskeletal Diseases

Interventions

The platform trial will be made up of a number of randomised controlled subtrials which will run in parallel with each other. It will start with a single subtrial but then others will be added as furt

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 65 years or over 2. Low maximum handgrip strength (15 s) (Inability to complete five sit to stands will count as a prolonged sit to stand time)

Exclusion criteria

Exclusion criteria: General: 1. Unable to give written informed consent 2. Currently enrolled in another intervention study (observational studies are permitted). 3. Currently participating in supervised exercise classes or physiotherapy 4. Any progressive neurological or malignant condition with life expectancy 3x ULN 2. Estimated glomerular filtration rate 10% in the last 6 months (to exclude significant cachexia) 7. Known uncontrolled thyrotoxicosis 8. 7.5mg/day or greater prednisolone use (or equivalent)

Design outcomes

Primary

Measure	Time frame
4-metre walk speed in m/s measured at baseline and 12-week follow-up	—

Secondary

Measure	Time frame
1. Grip strength in kg measured using a handgrip dynamometer at baseline and 12-week follow-up 2. 7-day physical activity measured using a body-worn activity monitor (Axivity AX6). The Mobilise-D algorithm will be used to assess digital mobility outcomes (DMOs): 2.1. Number of walking bouts undertaken per day 2.2. Mean daily walking bout duration (seconds) 2.3. Mean walking speed (metres per second) estimated from short walking bouts Measured at baseline and 12-week follow-up 3. Balance, lower extremity strength, and functional capacity measured using the Short Physical Performance Battery (overall score from 0 to 12) at baseline and 12-week follow-up 4. Intervention adherence evaluated by comparing the final tablet count at follow-up with the initial tablet allocation. Adherence will be calculated as (the number of tablets taken / the number of tablets expected to be taken by the final study visit) × 100 5. Withdrawal rate: number of participants not completing the 12-week follow-up 6. Number of adverse events: total number of adverse events reported and recorded at baseline, phone calls 2 and 7 days after baseline, and 12-week follow-up 7. Severity of adverse events: for each reported adverse event, an assessment of severity will be made according to the following criteria: 7.1. Mild: an event tolerated by the patient, causing minimal discomfort and not interfering with everyday activities 7.2. Moderate: an event sufficiently discomforting to interfere with normal everyday activities 7.3. Severe: an event that prevents normal everyday activities Measured at baseline, phone calls 2 and 7 days after baseline, and 12-week follow-up	—

Measure

Time frame

1. Grip strength in kg measured using a handgrip dynamometer at baseline and 12-week follow-up 2. 7-day physical activity measured using a body-worn activity monitor (Axivity AX6). The Mobilise-D algorithm will be used to assess digital mobility outcomes (DMOs): 2.1. Number of walking bouts undertaken per day 2.2. Mean daily walking bout duration (seconds) 2.3. Mean walking speed (metres per second) estimated from short walking bouts Measured at baseline and 12-week follow-up 3. Balance, lower extremity strength, and functional capacity measured using the Short Physical Performance Battery (overall score from 0 to 12) at baseline and 12-week follow-up 4. Intervention adherence evaluated by comparing the final tablet count at follow-up with the initial tablet allocation. Adherence will be calculated as (the number of tablets taken / the number of tablets expected to be taken by the final study visit) × 100 5. Withdrawal rate: number of participants not completing the 12-week follow-up 6. Number of adverse events: total number of adverse events reported and recorded at baseline, phone calls 2 and 7 days after baseline, and 12-week follow-up 7. Severity of adverse events: for each reported adverse event, an assessment of severity will be made according to the following criteria: 7.1. Mild: an event tolerated by the patient, causing minimal discomfort and not interfering with everyday activities 7.2. Moderate: an event sufficiently discomforting to interfere with normal everyday activities 7.3. Severe: an event that prevents normal everyday activities Measured at baseline, phone calls 2 and 7 days after baseline, and 12-week follow-up

—

Countries

England, United Kingdom

Contacts

Public ContactPhilippa Watts

revitalise@newcastle.ac.uk+44 (0)191 208 4591

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026