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Completed

NCT Number: NCT06175728

Feasbility and Efficacy of S-Press Leg Strengthening Device

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.

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Key information

Conditions

Deconditioning Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northamptonshire NHS Trust

Northampton, Northamptonshire, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

S-Press

Device

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

Primary outcomes

  1. Feasbility of use of S-Press by patients

    Time frame: through study completion, an average of 2 weeks

    30 minute Semi Structured Interview

  2. Feasbility of use of S-Press by Healthcare Professionals

    Time frame: through study completion, an average of 2 weeks

    30 minute Semi Structured Interview

Secondary outcomes

  1. 5x Sit to Stand time

    Time frame: through study completion, an average of 2 weeks

    time to complete 5 sit to stands from standardised chair

  2. Muscle thickness

    Time frame: through study completion, an average of 2 weeks

    Ultrasound measurement of Vastus Lateralis

  3. Heart rate during use

    Time frame: through study completion, an average of 2 weeks

    During exercise sessions

  4. Systolic Blood Pressure during use

    Time frame: through study completion, an average of 2 weeks

    During exercise sessions

  5. Diastolic Blood Pressure during use

    Time frame: through study completion, an average of 2 weeks

    During exercise sessions

Sponsors and collaborators

Lead sponsor

Sheffield Hallam University

Other

Collaborators

  • JT Rehab Ltd
  • NHS Northamptonshire

Registry information

Official study 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

Acronym: S-PRESS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 19, 2023
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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