Feasbility and Efficacy of S-Press Leg Strengthening Device

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility, Usability, Acceptability and Efficacy of a Novel Leg Strengthening Device (S-Press) for Strengthening Leg Muscles and Improving Physical Impairment During Hospital Admission

Conditions
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Deconditioning, Sarcopenia

Intervention / Treatment
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* Device: S-Press


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |