Feasbility and Efficacy of S-Press Leg Strengthening Device

NCT ID: NCT06175728

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-09-04

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.

Conditions

Deconditioning; Sarcopenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Use of S-Press

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

Group Type: EXPERIMENTAL

S-Press

Intervention Type: DEVICE

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

Interventions

S-Press

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Northamptonshire

UNKNOWN

Sponsor Role: collaborator

JT Rehab Ltd

INDUSTRY

Sponsor Role: collaborator

Sheffield Hallam University

OTHER

Sponsor Role: lead

Responsible Party

Tom Maden-Wilkinson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northamptonshire NHS Trust

Northampton, Northamptonshire, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

SPRESS1

Identifier Type: -

Identifier Source: org_study_id