Clinical trial NCT06175728: Feasbility and Efficacy of S-Press Leg Strengthening Device
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deconditioning
Sarcopenia
Lead sponsor: Sheffield Hallam University
Sponsor class: OTHER
Collaborators: name: NHS Northamptonshire
name: JT Rehab Ltd
First posted: 2023-12-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Feasbility of use of S-Press by patients
timeFrame: through study completion, an average of 2 weeks
measure: Feasbility of use of S-Press by Healthcare Professionals
timeFrame: through study completion, an average of 2 weeks
Secondary outcomes:
measure: 5x Sit to Stand time
timeFrame: through study completion, an average of 2 weeks
measure: Muscle thickness
timeFrame: through study completion, an average of 2 weeks
measure: Heart rate during use
timeFrame: through study completion, an average of 2 weeks
measure: Systolic Blood Pressure during use
timeFrame: through study completion, an average of 2 weeks
measure: Diastolic Blood Pressure during use
timeFrame: through study completion, an average of 2 weeks
Other outcomes:
Locations:
city: Northampton
country: United Kingdom
facility: Northamptonshire NHS Trust
state: Northamptonshire
Study officials:
References: