Feasbility and Efficacy of S-Press Leg Strengthening Device

NCT06175728 | Completed

• 1 other identifier: SPRESS1
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Deconditioning; Sarcopenia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 5x Sit to Stand time

  through study completion, an average of 2 weeks

• Muscle thickness

  through study completion, an average of 2 weeks

• Heart rate during use

  through study completion, an average of 2 weeks

• Systolic Blood Pressure during use

  through study completion, an average of 2 weeks

• Diastolic Blood Pressure during use

  through study completion, an average of 2 weeks

Study Arms (1)

Use of S-Press

EXPERIMENTAL

Use of the S-Press during in patient stay alongside usual physiotherapy sessions

Device: S-Press

Interventions

S-Press DEVICE

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

Use of S-Press

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Hallam University: lead
• NHS Northamptonshire: collaborator
• JT Rehab Ltd: collaborator

Study Sites (1)

Northamptonshire NHS Trust

Northampton, Northamptonshire, United Kingdom

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: December 19, 2023
• Study Start: April 1, 2021
• Primary Completion: January 31, 2023
• Study Completion: September 4, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)