Feasbility and Efficacy of S-Press Leg Strengthening Device | NCT06175728

Studies
Feasbility and Efficacy of S-Press Leg Strengthening Device

NCT06175728

Sponsor

Sheffield Hallam University

Status

Completed

Last Update Posted

Dec 19, 2023Actual

Enrollment

9Actual

Phase

Not Applicable

Conditions

Deconditioning
Sarcopenia

Interventions

S-Press

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Actual

Primary Completion Date

Jan 31, 2023Actual

Completion Date

Sep 4, 2023Actual

First Submitted Date

Sep 6, 2023

First Submission Date that Met QC Criteria

Dec 15, 2023

First Posted Date

Dec 19, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2023

Last Update Posted Date

Dec 19, 2023Actual

Name	Class
NHS Northamptonshire	UNKNOWN
JT Rehab Ltd	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Use of S-Press	Experimental	Use of the S-Press during in patient stay alongside usual physiotherapy sessions	Device: S-Press

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S-Press	Device	Leg Strengthening Device that can be used in supine and seated positions	Use of S-Press

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasbility of use of S-Press by patients	30 minute Semi Structured Interview	through study completion, an average of 2 weeks
Feasbility of use of S-Press by Healthcare Professionals	30 minute Semi Structured Interview	through study completion, an average of 2 weeks

Secondary Outcomes

Measure	Description	Time Frame
5x Sit to Stand time	time to complete 5 sit to stands from standardised chair	through study completion, an average of 2 weeks
Muscle thickness	Ultrasound measurement of Vastus Lateralis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Northamptonshire NHS Trust		Northampton	Northamptonshire		United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual data are available on request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 12, 2020	Sep 6, 2023	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D055948	Sarcopenia

Ancestor Terms

ID	Term
D009133	Muscular Atrophy
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided