DeconditioningS-PRESSNCT06175728
Feasbility and Efficacy of S-Press Leg Strengthening Device
A study testing S-Press in people with Deconditioning and Sarcopenia, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deconditioning, Sarcopenia
- What is being tested?
- S-Press
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2021to 4 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northamptonshire NHS Trust
Northampton, Northamptonshire
About this study
Official title: Feasibility, Usability, Acceptability and Efficacy of a Novel Leg Strengthening Device (S-Press) for Strengthening Leg Muscles and Improving Physical Impairment During Hospital Admission
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.
- Conditions
- Deconditioning, Sarcopenia
- Being tested
- S-Press
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-PressDevice
Leg Strengthening Device that can be used in supine and seated positions
| Study group | Role | What they receive |
|---|---|---|
| Use of S-Press | Experimental | Use of the S-Press during in patient stay alongside usual physiotherapy sessions Receives: Device: S-Press |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasbility of use of S-Press by patients
30 minute Semi Structured Interview
Measured: through study completion, an average of 2 weeks
Feasbility of use of S-Press by Healthcare Professionals
30 minute Semi Structured Interview
Measured: through study completion, an average of 2 weeks
Secondary outcomes (5)
5x Sit to Stand time
time to complete 5 sit to stands from standardised chair
Measured: through study completion, an average of 2 weeks
Muscle thickness
Ultrasound measurement of Vastus Lateralis
Measured: through study completion, an average of 2 weeks
Heart rate during use
During exercise sessions
Measured: through study completion, an average of 2 weeks
Systolic Blood Pressure during use
During exercise sessions
Measured: through study completion, an average of 2 weeks
Diastolic Blood Pressure during use
During exercise sessions
Measured: through study completion, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start1 Apr 2021
- Primary completion31 Jan 2023
- Study completion4 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeconditioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Northamptonshire, JT Rehab Ltd
- Responsible party
- Principal investigator, Tom Maden-Wilkinson, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175728
- Sponsor's protocol ID
- SPRESS1
- Acronym
- S-PRESS
- Status last verified
- Dec 2023
- First submitted
- 6 Sep 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data are available on request
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Usability, Acceptability and Efficacy of a Novel Leg Strengthening Device (S-Press) for Strengthening Leg Muscles and Improving Physical Impairment During Hospital Admission
- ClinicalTrials.gov ID
- NCT06175728
- Acronym / sponsor ID
- S-PRESS / SPRESS1
- Conditions
- Deconditioning, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- NHS Northamptonshire, JT Rehab Ltd
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 4 Sep 2023 (actual)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of S-Press | Experimental | Device: S-PressUse of the S-Press during in patient stay alongside usual physiotherapy sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- Any patient who is unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-PressLeg Strengthening Device that can be used in supine and seated positions | Device | Use of S-Press |
Primary outcome
Feasbility of use of S-Press by patients
Time frame: through study completion, an average of 2 weeks
30 minute Semi Structured Interview
Feasbility of use of S-Press by Healthcare Professionals
Time frame: through study completion, an average of 2 weeks
30 minute Semi Structured Interview
5 secondary outcomes
5x Sit to Stand time
Time frame: through study completion, an average of 2 weeks
Muscle thickness
Time frame: through study completion, an average of 2 weeks
Heart rate during use
Time frame: through study completion, an average of 2 weeks
Systolic Blood Pressure during use
Time frame: through study completion, an average of 2 weeks
Diastolic Blood Pressure during use
Time frame: through study completion, an average of 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No. Individual data are available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-Press in people with Deconditioning and Sarcopenia, run by Sheffield Hallam University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasbility of use of S-Press by patients (time frame: through study completion, an average of 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.