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| ID | Type | Description | Link |
|---|---|---|---|
| RCSI-SJH-MISA | Other Identifier | RCSI-SJH-MISA | |
| RCSI-SJH-MISA-2013 | Other Identifier | RCSI-SJH-MISA-2013 |
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| Name | Class |
|---|---|
| St. James's Hospital, Ireland | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistance training | Experimental | Usual care and resistance exercises. |
|
| Usual care | Other | Usual inpatient physiotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance training | Other | Usual physiotherapy care and twice weekly tailored and progressive resistance lower limb exercises Circuit-type format, sessions will last 35 minutes and will include a warm-up and cool-down period. Exercises tailored to each patient and will use ankle weights as the resistance, using 65-75% of their 1-Repetition Maximum. Intervention will last for 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Skeletal muscle mass |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sinead Coleman, MSc | St James's Hospital, James's Street, Dublin 8, Ireland | Principal Investigator |
| Frances Horgan, PhD | Royal College of Surgeons in Ireland | Principal Investigator |
| Niamh Murphy, MSc | St James's Hospital, James's Street, Dublin 8, Ireland | Study Director |
| Gareth Clifford, MSc | St James's Hospital, James's Street, Dublin 8, Ireland | Study Director |
| David Robinson, MD | St James's Hospital, James's Street, Dublin 8, Ireland | Study Director |
| Conal Cunningham, MD | St James's Hospital, James's Street, Dublin 8, Ireland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physiotherapy Department, St James's Hospital, James's Street, Dublin 8, Ireland | Dublin | 8 | Ireland |
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| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Feasibility study Randomised and controlled
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| Usual care | Other | Standard inpatient 'usual care' physiotherapy |
|
| 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 |
| 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 |
| 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 |
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 |
| Grip Strength | Grip strength will be measured using a handgrip dynamometer on the non-dominant arm (Clinifeed/Roussel dynamometer). | Baseline, Week 6 |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |