Muscle Weakness Clinical Trial
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 Feasibility Study
Verified date | April 2017 |
Source | Royal College of Surgeons, Ireland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 1, 2019 |
Est. primary completion date | June 30, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Ireland | Physiotherapy Department, St James's Hospital, James's Street, Dublin 8, Ireland | Dublin |
Lead Sponsor | Collaborator |
---|---|
Royal College of Surgeons, Ireland | St. James's Hospital, Ireland |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Height and Weight and BMI | Height will be measured from ulna length (BAPEN, 2004), weight will be measured using body composition scales, and body mass index (BMI) calculated using these measures. | Baseline, Week 6 | |
Other | Skeletal muscle mass | Skeletal muscle mass will be calculated using a validated equation based on measured bioimpedance from the body composition scales (Janssen J Appl Phil 2000). | Baseline, Week 6 | |
Other | Grip Strength | Grip strength will be measured using a handgrip dynamometer on the non-dominant arm (Clinifeed/Roussel dynamometer). | Baseline, Week 6 | |
Primary | Lower limb dynamometry | 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. | Baseline, Week 6 | |
Secondary | Functional mobility using the Timed Up and Go (TUG) | 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. | Baseline, Week 6 | |
Secondary | Six Minute Walk Test (6MWT) | 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. | Baseline, Week 6 | |
Secondary | EuroQol-5D (EQ-5D) | 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. | Baseline, Week 6 | |
Secondary | Canadian Study of Health and Ageing Clinical Frailty Scale (CFS) | 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). | Baseline, Week 6 |
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