Feasbility and Efficacy of S-Press Leg Strengthening Device

Sarcopenia Clinical Trial

— S-PRESS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06175728
• Other study ID #: SPRESS1
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: September 4, 2023

Study information

• Verified date: December 2023
• Source: Sheffield Hallam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 4, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deconditioning
• Sarcopenia

Intervention

Device:
• S-Press
Leg Strengthening Device that can be used in supine and seated positions

Locations

Country	Name	City	State
United Kingdom	Northamptonshire NHS Trust	Northampton	Northamptonshire

Sponsors (3)

Lead Sponsor	Collaborator
Sheffield Hallam University	JT Rehab Ltd, NHS Northamptonshire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasbility of use of S-Press by patients	30 minute Semi Structured Interview	through study completion, an average of 2 weeks
Primary	Feasbility of use of S-Press by Healthcare Professionals	30 minute Semi Structured Interview	through study completion, an average of 2 weeks
Secondary	5x Sit to Stand time	time to complete 5 sit to stands from standardised chair	through study completion, an average of 2 weeks
Secondary	Muscle thickness	Ultrasound measurement of Vastus Lateralis	through study completion, an average of 2 weeks
Secondary	Heart rate during use	During exercise sessions	through study completion, an average of 2 weeks
Secondary	Systolic Blood Pressure during use	During exercise sessions	through study completion, an average of 2 weeks
Secondary	Diastolic Blood Pressure during use	During exercise sessions	through study completion, an average of 2 weeks