PAIVE - Preventing Atrophy in Immobile Vulnerable Elderly. Does high dose exercise or electrical muscle stimulation (compared to standard physiotherapy) improve strength and function in an elderly, immobile, cognitively intact, non-weight bearing, in patient population?

The primary aim of this study is to evaluate the feasibility of the intervention groups and the selected outcome measures. In particular, we will assess recruitment rates, retention rates, adherence to the intervention, staff workload and feedback and explore any treatment effects on muscle strength and function to inform the design (including sample size) of a larger randomized controlled trial. The secondary aim of this study is to evaluate quadriceps strength and patient function in 3 different exercise programs (low dose – control, high dose and use of NMES) during the non weight bearing / touch weight bearing period in an elderly, cognitively intact, in-patient population. STUDY TYPE & DESIGN & SCHEDULE 1. Feasibility Study. Each consenting participant at Western Health will be independently randomized into one of three groups. Participants may transfer between GEM units during the admission or may be transferred to bed based transitional care at Hazeldean (BB TCP). The participants will continue with the treatment group they have been randomized to for the duration of the in-patient stay. If the participant becomes acutely unwell and is transferred to an acute unit then their treatment will need to be suspended and hence they will drop out of the study. If the participant is discharged from hospital during their NWB/TWB period, they will also be withdrawn from the study. 2. Population to be studied: English speaking, elderly >65 years who have a fracture (any) of the lower limb preventing them from walking. They have been instructed to be non weight bearing or touch weight bearing by the orthopedic team for a set time period and are unable to safely mobilise with these restrictions. They are current in-patients of the GEM wards or BB TCP ward at Western Health and are cognitively intact. We will ensure that participants with contraindications to NMES (as per the manufacturers instructions) will be excluded from the study. 3. This study will be conducted only at Western Health, across all 4 sites: Footscray, Sunshine, Williamstown and Transitional Care (Hazeldean). 4. Measuring the strength of the quadriceps muscle will inform us of change within each group in the NWB/TWB period and also difference between groups. The key outcome for measuring functional change will be to measure TUG at discharge. This in conjunction with further information regarding FIM, LOS and DXA / pQCT will inform physiotherapy practice regarding the optimal management of this patient group. 5. Data to be collected includes quadriceps strength (via a dynamometer), DXA / pQCT at mid thigh region / calf region respectively, Functional Independence Measure (FIM), Timed Up and GO (TUG) and hospital length of stay. 6. All data will be collected and stored securely in locked cupboards at each site. 7. There will initially be a screening process to gain informed consent. On initial assessment, quadriceps strength (unaffected leg), FIM and DXA / pQCT scan (Sunshine Hospital participants only) will be collected, as well as data on clinical frailty score, self-reported falls in the past 6 months, and Functional Comorbidity Index score, On completion of non weight bearing / touch weight bearing period quadriceps strength will be tested on both the affected and unaffected lower limbs and also DXA / pQCT scans will be conducted for Sunshine Hospital patients only. On discharge, the functional based outcome measures will be collected (FIM) as well as quadriceps strength via dynamometer and TUG. LOS following completion of the NWB/TWB period will also be calculated. 8. There will be follow up testing at 3 months post cessation of the non weight bearing / touch weight bearing period. All outcome measures will be collected again via the participant attending Sunshine Hospital. There will be 3 attempts made to contact the participant to attend the 3 month follow up. If they are unable to be contacted after 3 reasonable attempts the participant will be classified as loss to follow up. STANDARD CARE PROCEDURES: 1. Independent written exercse program recorded in exercise diary prescribed for participant during initial assessment by Physiotherapist. Program is individualised to patient. Patient will be asked daily 'Have you completed your exercises today and recorded this in your exercise diary?'. This prompt will be worded by the clinician/AHA exactly as above to ensure consistency between participants. 2. Attendance at group exercise class - conducted by AHA and offered group therapy twice weekly and exercises completed as per group exercise sheet 3. Guided exercise program completed by AHA or physiotherapist once per week (1/2 hour session). Exercises individualised to patient. Standard care will be delivered to the patient for the duration of their inpatient stay. ADDITION TO STANDARD CARE 1. NMES (Neuro muscular electrical stimulation) will be completed daily under physiotherapist or AHA supervision. 25mins each leg 4 x weekly as per 'Disuse atrophy' program via Chattanooga Wireless Professional NMES device. This is in addition to standard care procedures and will be delivered to the patient for the duration of their inpatient stay. Details of NMES Disuse Atrophy Program warm up contraction active rest final recovery phase FREQUENCY 6 Hz 35 Hz 4 Hz 3 Hz DURATION OF RAMP-UP 1.5 s 1.5 s 0.5 s 1.5 s DURATION OF PHASE 2 min 6 s 7 s 3 min DURATION OF RAMP-DOWN 2 s 0.75 s 0.5 s 3 s 2. High dose exercise program (frequency of treatment is additional to standard care) and will be completed face to face by the AHA or Physiotherapist treating the patient on the ward. The intervention will occur either at the patient's bedside or in the Physiotherapy gym. An additional 3 x per week (1/2 hour sessions). This additional exercise program will be created by the treating physiotherapist of which the exercises will be individualised to patient. Equipment such as weights or theraband may be used and will be based on the patient's current strength, range of movement and level of function, taking into account the non weight bearing restrictions of the affected lower limb. This is in addition to standard care procedures and will be delivered to the patient for the duration of their inpatient stay.