Feasibility of Additional Physiotherapy for Patients Aged 75 and Older

Study Overview
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Brief Summary
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On average, people become physically weaker during even a short stay in hospital. This study is a feasibility/pilot study to see if additional physiotherapy exercises undertaken in hospital is feasible and acceptable to patients. The study will compare two different types of physiotherapy exercise. Both exercise programmes involve twice-daily physiotherapy provided by one of the hospital's physiotherapy assistants, but only one of the two exercise programmes expected to provide benefit. This is on top of the care that people would normally receive, and will last for the first 7 days of their hospital admission (or until they are discharged if this is earlier). Patients will be asked to consent to the study during the first 36 hours of their hospital admission. If patients provide consent, they will undergo a baseline assessment of their functional ability (including testing of their muscle strength) before being randomly assigned to one of the two exercise programmes. The study aims to recruit 15 patients to each group (30 in total). Once randomised patients will be seen twice a day by a physiotherapy assistant who will supervise the exercise programme. On the day that participants are discharged (or day 7 of their admission if earlier) the assessor will repeat measures of the participants functional ability. Following these measures participants will be invited to be interviewed to discuss their experience of taking part in the study. Approximately one month after discharge, a researcher will visit the participant to repeat measures of their functional ability at their home.

Official Title
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Pilot Study of an Exercise Programme to Maintain Knee Extension Muscle Strength for Older Patients During Hospitalisation

Conditions
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Exercise, Hospitalisation, Older Adults

Intervention / Treatment
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* Other: Strengthening exercises
* Other: Stretching exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to CUH, who are aged 75 or older, able to give informed consent and expected to be hospitalised more than 24 hours. Exclusion Criteria: Admitted more than 36 hours prior to recruitment; unable to provide informed consent (e.g. due to dementia, delirium, cognitive impairment); receiving end of life care or oncological treatment for diagnosed cancer; inability to cooperate in muscle strength testing (e.g. unable to sit in chair, or presence of skin integrity problems contraindicating the use of a hand-held dynamometer); transferred to or from the intensive care unit; bed-bound or requiring a hoist to transfer from bed to chair 2 weeks prior to hospitalisation; or if the Consultant in charge of the patient has any other clinical concerns regarding participation in a strengthening exercise programme.

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention/Strengthening<br> | Other: Strengthening exercises<br>* The intervention group will receive 2 supervised exercise sessions a day. The exercise consists of progressive resistance training based around the movement of standing up/sitting down.<br>|
| Sham Comparator: Control/Stretching<br> | Other: Stretching exercises<br>* The intervention group will receive 2 supervised exercise sessions a day. The exercise consists of gentle stretching of upper limbs and lower limbs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Topic-guided interview of participants at discharge from hospital |  | At day 7 of hospitalisation (or at discharge if earlier) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Topic-guided semi-structured interview of the group of physiotherapy assistants who delivered the intervention |  | At day 7 of hospitalisation (or at discharge if earlier) | 
| Hand held dynamometry (Knee extension + grip strength) |  | At day 7 of hospitalisation (or at discharge if earlier), follow up 6 weeks after discharge | 
| de Morton Mobility Index | Scale from 0-100, 100 representing highest functional ability | At day 7 of hospitalisation (or at discharge if earlier), follow up 6 weeks after discharge | 
| Barthel Index | Scale from 0-100, 100 representing highest functional ability | 6 weeks after discharge | 
| Falls Efficacy Scale International | Scale from 16-64, 16 representing highest perceived self efficacy of avoiding falling | 6 weeks after discharge | 
| Confidence measured on a visual analogue scale | Scale from 0-100, 100 representing highest level of confidence. | 6 weeks after discharge | 
| Mini-Addenbrookes Cognitive Examination | Scale from 0-30, 30 representing highest cognitive ability. | 6 weeks after discharge | 
| Survey of Health, Ageing and Retirement in Europe (SHARE) Frailty Instrument | A continuous scale, with a higher number representing a higher degree of frailty | 6 weeks after discharge | 
| Physical activity in hospital | Measured with accelerometers | 6 weeks after discharge |