Feasbility and Efficacy of S-Press Leg Strengthening Device (S-PRESS)

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Deconditioning
• Intervention / Treatment: Device: S-Press

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Northamptonshire
    • Northampton, Northamptonshire, United Kingdom
      • Northamptonshire NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Use of S-Press; Use of the S-Press during in patient stay alongside usual physiotherapy sessions	Device: S-Press; Leg Strengthening Device that can be used in supine and seated positions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	through study completion, an average of 2 weeks
Heart rate during use	During exercise sessions	through study completion, an average of 2 weeks
Systolic Blood Pressure during use	During exercise sessions	through study completion, an average of 2 weeks
Diastolic Blood Pressure during use	During exercise sessions	through study completion, an average of 2 weeks

Collaborators and Investigators

• Sponsor: Sheffield Hallam University
• Collaborators: NHS Northamptonshire; JT Rehab Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): September 4, 2023

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): December 19, 2023

Study Record Updates

• Last Update Posted (Actual): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: SPRESS1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data are available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No