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CompletedNCT06175728S-PRESSUpdated Dec 19, 2023

Feasbility and Efficacy of S-Press Leg Strengthening Device

An interventional study of S-Press in Deconditioning and Sarcopenia, sponsored by Sheffield Hallam University. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-19.

Sponsored by Sheffield Hallam University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Apr 2021, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The proposed study will examine the use and effectiveness of a novel strength training device - The S-Press within an NHS environment. The S-Press is a portable exercise device that can be used seated or lying down and specifically targets the knee extensors and flexors. The knee extensors are particularly important in the performance of activities of daily living such as rising from a chair, walking up and down stairs and walking.

Resistance training is the most effective strategy to help to reduce muscle wasting in response to ageing or chronic disuse; however as current in-patient settings likely fail to produce an overload stimulus to the muscle for hypertrophy and strength gains, there is a need to develop new interventions and equipment to help deliver this. The S-Press is designed by a Physiotherapist with the goal of increasing muscle strength and improving physical function in patients who may be confined to their bed or chair or unable to join in with standard physiotherapy treatments.

This mixed methods study will examine the efficacy of the S-Press to improve muscle size using B-Mode Ultrasound and physical function, using sit to stand x5 with use over 6 weeks, alongside the qualitative experience of the use of the S-Press through a one to one semi structured interview.

02

Conditions studied

  • Deconditioning
  • Sarcopenia

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03

In context

Sarcopenia

1,242 studies on the registry are indexed under Sarcopenia; 405 are open to participants now.

This study's enrollment of 9 is below the median of 60 across 793 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Sheffield Hallam University is the lead sponsor of 48 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Any in-patient admitted onto the ward sites for therapy intervention, assessed as medically stable and physically able to participate by nursing staff and able to provide informed written consent for participation.

Exclusion criteria

Exclusion Criteria:

  • Any patient who is unable to give informed consent.

    • Significantly confused patients - may not understand or retain the information to perform the exercises so will be excluded from this study.
    • Patients with unstable or deteriorating medical conditions or are acutely unwell with an infection.
    • Patients unable to do leg press exercise
    • Patients who have had major surgery or myocardial infarction within the past 6 months.
    • Patients who have major surgery scheduled during the intervention period.
    • Patients currently undergoing treatment for cancer
    • Patients who currently have high blood pressure that is uncontrolled (Systolic >200mmHg or Diastolic > 110mmHg)
    • Patients with a physical disability that precludes safe and adequate testing.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Use of S-Press

    Use of the S-Press during in patient stay alongside usual physiotherapy sessions

    Device: S-Press

Interventions

  • DeviceS-Press

    Leg Strengthening Device that can be used in supine and seated positions

06

What researchers measure

Primary outcomes

  1. Feasbility of use of S-Press by patients

    30 minute Semi Structured Interview

    Time frame: through study completion, an average of 2 weeks

  2. Feasbility of use of S-Press by Healthcare Professionals

    30 minute Semi Structured Interview

    Time frame: through study completion, an average of 2 weeks

Secondary outcomes

  1. 5x Sit to Stand time

    time to complete 5 sit to stands from standardised chair

    Time frame: through study completion, an average of 2 weeks

  2. Muscle thickness

    Ultrasound measurement of Vastus Lateralis

    Time frame: through study completion, an average of 2 weeks

  3. Heart rate during use

    During exercise sessions

    Time frame: through study completion, an average of 2 weeks

  4. Systolic Blood Pressure during use

    During exercise sessions

    Time frame: through study completion, an average of 2 weeks

  5. Diastolic Blood Pressure during use

    During exercise sessions

    Time frame: through study completion, an average of 2 weeks

07

Study locations

1 site
  • Northamptonshire NHS Trust
    Northampton, Northamptonshire, United Kingdom
08

References and documents

Study documents

  • Study protocol · Jan 12, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Individual data are available on request

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2021 to primary completion in Jan 2023, 21 months.

Of 474 non-industry interventional studies with no phase under Sarcopenia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's 21 months is above that.

Counting every sponsor, half of 485 studies reached it within 18 months; a quarter within 8 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 6, 2023
First posted
Dec 19, 2023
StartActual
Apr 1, 2021
Primary completionActual
Jan 31, 2023
CompletionActual
Sep 4, 2023
Last update
Dec 19, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06175728
Lead sponsor
Sheffield Hallam University
Collaborators
NHS Northamptonshire, JT Rehab Ltd
Responsible party
Tom Maden-Wilkinson (Associate Professor, Sheffield Hallam University) — Principal investigator
First posted
Dec 19, 2023
Start date
Apr 1, 2021
Primary completion
Jan 31, 2023
Completion
Sep 4, 2023
Last update
Dec 19, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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