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Clinical Trials/NCT02141126
NCT02141126
Completed
Not Applicable

Can Lower Limb Resistance Training Improve Strength, Muscle Mass and Functional Outcomes in Older Inpatients in a Post-acute Rehabilitation Unit? A Randomised Controlled Feasibility Study

Royal College of Surgeons, Ireland1 site in 1 country60 target enrollmentJuly 1, 2013
ConditionsMuscle Weakness

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Muscle Weakness
Sponsor
Royal College of Surgeons, Ireland
Enrollment
60
Locations
1
Primary Endpoint
Lower limb dynamometry
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The primary aim of this feasibility study is to evaluate the feasibility of delivering a PRT programme in an inpatient older person rehabilitation setting and to describe changes in lower limb strength and physical function following six weeks of resistance training and routine physiotherapy versus a control group of routine physiotherapy only in an older inpatient population.

Detailed Description

This is a prospective, single blinded, randomised controlled feasibility study recruiting consecutive appropriate patients in this post-acute rehabilitation unit. Feasibility outcomes including safety, recruitment, measurements, adherence, retention and satisfaction will be evaluated. There are two groups (i) exercise intervention and (ii) control. It will not be possible to blind the treating physiotherapist or the patient to the exercise intervention; hence the single (assessor) blinded design. The study will be based in St James's Hospital, Dublin. Assessments and the delivery of the exercise intervention will be conducted in the Physiotherapy department. Patients will be recruited in the inpatient setting. Appropriate patients will be approached, and the intervention explained to them. The patient will be given an information leaflet and 24-hours to consider involvement in the study

Registry
clinicaltrials.gov
Start Date
July 1, 2013
End Date
September 1, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Royal College of Surgeons, Ireland
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients, male and female elderly inpatients 65 years.
  • Patients must be medically stable.
  • Patients who are able to follow one-stage commands.
  • Patients must be able to give informed consent.

Exclusion Criteria

  • Unstable medical condition.
  • Patients who are unable to follow one-stage commands.
  • Acute pain or fracture
  • Patients who are unable to stand or require more than assistance of two staff to mobilise/transfer.
  • Patients who have been admitted with a recent diagnosis of stroke, due to their varying patterns of recovery.

Outcomes

Primary Outcomes

Lower limb dynamometry

Time Frame: Baseline, Week 6

Lower limb dynamometry will be measured using the Power Track II Commander by J-Tech Medical. A previous study in this rehabilitation unit has determined that this is a reliable measure of lower limb strength in this population. The primary outcome measurement will be quadriceps muscle strength.

Secondary Outcomes

  • Functional mobility using the Timed Up and Go (TUG)(Baseline, Week 6)
  • EuroQol-5D (EQ-5D)(Baseline, Week 6)
  • Canadian Study of Health and Ageing Clinical Frailty Scale (CFS)(Baseline, Week 6)
  • Six Minute Walk Test (6MWT)(Baseline, Week 6)

Study Sites (1)

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