Clinical Trial: Lower Limb Resistance Training in Older Inpatients

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: The primary aim of this research is to evaluate 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 Summary:

This is a prospective, single blinded, randomised controlled trial recruiting consecutive appropriate patients in this post-acute rehabilitation unit.

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


Sponsor: Royal College of Surgeons, Ireland

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Functional mobility using the Timed Up and Go (TUG) [ Time Frame: Baseline, Week 6 ]
    Functional mobility using the Timed Up and Go (TUG) - this is a test of basic functional mobility for frail elderly people. The patient is asked to stand up from a chair, walk three metres, turn around and return to the chair, while being timed by the assessor.
  • Six Minute Walk Test (6MWT) [ Time Frame: Baseline, Week 6 ]
    Six Minute Walk Test (6MWT) - this is a performance-based test. The distance walked in six minutes is measured and reported in metres or feet and is an indication of exercise tolerance.
  • EuroQol-5D (EQ-5D) [ Time Frame: Baseline, Week 6 ]
    EuroQol-5D (EQ-5D) - measures health related quality of life, it contains a visual analogue scale (0 to 100, representing dead to excellent health state) and five items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
  • Canadian Study of Health and Ageing Clinical Frailty Scale (CFS) [ Time Frame: Baseline, Week 6 ]
    Canadian Study of Health and Ageing Clinical Frailty Scale (CFS) - this is a measure of frailty based on clinical judgement. It is an ordinal scale which ranges from 1 to 7. Reliability and validity have been proven in an older population (Rockwood et al, 2005).


Original Secondary Outcome: Same as current

Information By: Royal College of Surgeons, Ireland

Dates:
Date Received: January 6, 2014
Date Started: June 2013
Date Completion: December 2017
Last Updated: April 24, 2017
Last Verified: April 2017