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Trial registered on ANZCTR


Registration number
ACTRN12619001367134p
Ethics application status
Submitted, not yet approved
Date submitted
20/09/2019
Date registered
8/10/2019
Date last updated
8/10/2019
Date data sharing statement initially provided
8/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Individualized therapy for elderly patients using exercise and nutrition to reduce dependence post discharge trial
Scientific title
Effect of dietary and exercise modification versus standard care on frailty, nutrition status, strength, length of hospital stay, hospital readmission rate, mortality, quality of life and associated costs in hospitalised malnourished patients
Secondary ID [1] 298767 0
NIL
Universal Trial Number (UTN)
U1111-1237-1587
Trial acronym
INDEPENDENCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty in hospitalised elderly patients 313705 0
Condition category
Condition code
Diet and Nutrition 312118 312118 0 0
Other diet and nutrition disorders
Physical Medicine / Rehabilitation 312429 312429 0 0
Physiotherapy
Public Health 312430 312430 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A community extended individualised nutrition and exercise care plan that spans 3-months post discharge. They will receive both nutrition and exercise intervention during admission. After discharged, they will be supported through an ambulatory service in the form of home visits and telephone calls.

Nutrition therapy – The FMC dietitian will formulate an individualised nutrition care plan tailored to their medical conditions, nutritional requirements and food preferences, which will be provided while patient is admitted. The medical nutrition therapy (MNT) will aim at providing 100 per cent of their energy and protein requirements to achieve ideal body weight, estimated from the Harris Benedict equation used in acute setting (Roza & Shizgal 1984). Medical nutrition therapy provided can include the use of commercial oral nutrition supplements (selected within hospital’s inpatient formulary where costs are covered), mid-meal snacks (limited to hospital’s food service menu) and food fortification strategies, catered to the individual patient’s preferences and tolerance. Optimal care in terms of frequency of reviews and input will be left to the discretion of the dietitian as individualised therapy will vary between patients. The dietitian will suggest a multivitamin/mineral if deemed necessary, but prescription will be left to the discretion of treating clinicians. Dietetic counselling, with an aim to augment energy and protein intake, will be provided to patients and their caregivers prior to discharge to ensure continuity of the nutritional care plan at home. If patient is not seen by the ward dietitian, he/she will be assessed at the initial home visit. If the patient is to be discharged to a nursing home, the recommended nutritional care plan will be forwarded to the respective care managers.

Exercise therapy – In addition to any usual physiotherapy care, patients will also receive a daily supervised chair stand and heel-raise exercise-training program that is individualised to their physical capacity, adapted from the STAND-Cph trial (Pedersen et al. 2016). Following a warmup, patients will complete the chair stand and heel raise exercises, supervised by an allied health assistant or professional. Exercise progression is individually determined, and each inpatient session will last 10-15 minutes. Program oversight will be provided by each patients’ treating physiotherapist and patients will be assisted to self-regulation by monitoring perceived exertion, ensuring safe program delivery.

In the first part of the exercise program, patient will be asked to sit in a hospital chair with arm rest and approximately 45cm seat height. The back of the chair will be placed against a wall to prevent it from sliding during exercise. The patient will then be asked to rise to a fully extended position and sit down at a constant rate. They will be verbally encouraged by the exercise- allied health assistant or professional to perform as many as possible to ensure training to failure of muscle contraction during the initial visit. Should the patient be able to perform more than 12 reps without assistance, he/she will progress to the next level, performing the exercise while wearing the weighted vest (1-9kg), to reach 8-12 RM and so forth. If the patient is unable to perform eight repetitions at standard level, they are permitted to regress to below standard level, allowing them to use the armrest in the concentric phase, and so on. Patients will be asked to repeat the three set of 12 reps, with a 2-min pause allowed between sets. The Borg rate of perceived exertion scale will help guide the allied health assistant or professional in progression or regression of the exercise intensity.

In the second part of the exercise program, patient will be asked to position the chair such that the chair faces the wall to prevent it from sliding during exercise. The patient will be asked to stand behind a chair for balance support. Before beginning, they will be asked to keep the feet on the floor at shoulder width. They will then be directed to lift both heels to stand on their forefeet and lower their heels to a standing position at a constant pace. During training, allied health assistant or professional will verbally encourage the patient to perform as many repetitions as possible, maintaining the same pace to ensure training to contraction failure. Should the patient be able to perform more than 12 reps without assistance, he/she will progress to the next level, performing the exercise while wearing the weighted vest (1-9kg), to reach 8-12 repetition max (RM) and so forth. Similarly, the Borg rate of perceived exertion scale will help guide the allied health assistant or professional in progression or regression of the exercise intensity.

Before and upon completion of the exercise, patients will also self-rate the degree of muscle soreness from previous rep on the numerical rating scale (NRS) from 0 to 10 (no pain to worst possible pain) upon completion of a level (Bergh et al 2000). Patients will only proceed if they have pain score or less than 5.

Community therapy and follow-up – After discharge, patients will be provided with an ambulatory nutrition-exercise service (4 home visits and 4 telephone calls within 3 months). This is to ensure compliance to both therapies and to troubleshoot related issues i.e. unable to perform dietary modifications. They will be guided by a dietitian with training in exercise supervision to ensure continuity of dietetic care and exercise at home. At the first home visit, patients will be taught strengthening exercises (front knee, back knee, side hip, toe raises, calf raise, sit to stand) from the Otago community exercise program in addition to a refresher of the inpatient exercises (Liu-Ambrose et al 2008). Both set of exercises are to be done 3 times a week, on alternate days, for a period of 3 months post discharge. To sustain engagement, patients will also receive health coaching during the home visits/telephone calls– a one-on-one patient-health provider approach model with motivational interviewing.

References
Bergh, I., Sjöström, B., Odén, A. and Steen, B., 2000. An application of pain rating scales in geriatric patients. Aging Clinical and Experimental Research, 12(5), pp.380-387.
Liu-Ambrose, T., Donaldson, M.G., Ahamed, Y., Graf, P., Cook, W.L., Close, J., Lord, S.R. and Khan, K.M., 2008. Otago home-based strength and balance retraining improves executive functioning in older fallers: a randomized controlled trial. Journal of the American Geriatrics Society, 56(10), pp.1821-1830.
Pedersen, M.M., Petersen, J., Beyer, N., Damkjær, L. and Bandholm, T., 2016. Supervised progressive cross-continuum strength training compared with usual care in older medical patients: study protocol for a randomized controlled trial (the STAND-Cph trial). Trials, 17(1), p.176.
Roza, A.M. and Shizgal, H.M., 1984. The Harris Benedict equation reevaluated: resting energy requirements and the body cell mass. The American journal of clinical nutrition, 40(1), pp.168-182.
Intervention code [1] 315029 0
Treatment: Other
Intervention code [2] 315030 0
Rehabilitation
Comparator / control treatment
The control group A will receive intervention upon referral by their respective primary clinicians as per usual care.
Control group
Active

Outcomes
Primary outcome [1] 320757 0
Frailty score as assessed with the Edmonton Frail Scale
Timepoint [1] 320757 0
Baseline, 3- and 6-months
Secondary outcome [1] 372743 0
Nutrition status as assessed by the patient generated subjective global assessment
Timepoint [1] 372743 0
Baseline, 3- and 6-months
Secondary outcome [2] 373907 0
Handgrip strength with a dynamomter
Timepoint [2] 373907 0
Baseline, 3- and 6-months
Secondary outcome [3] 373911 0
Hospital Admission Risk Profile
Timepoint [3] 373911 0
Baseline, 3- and 6-months
Secondary outcome [4] 373912 0
Short Physical Performance Battery
Timepoint [4] 373912 0
Baseline, 3- and 6-months
Secondary outcome [5] 373913 0
EQ-5D
Timepoint [5] 373913 0
Baseline, 3- and 6-months
Secondary outcome [6] 373914 0
Geriatric Depression Scale
Timepoint [6] 373914 0
Baseline, 3- and 6-months
Secondary outcome [7] 373915 0
Mini mental state examination
Timepoint [7] 373915 0
Baseline, 3- and 6-months

Eligibility
Key inclusion criteria
• 65 years or older
• able to understand verbal/nonverbal instructions (MMSE score 24 and above)
• Not bed or wheelchair-bound
• have access to a telephone or mobile phone at home
• Have an Edmonton Frail Scale (EFS) of 6 and above
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Receiving palliative care
• Living outside of the SALHN areas
• On home oxygen

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All eligible patients admitted under general medicine will be screened by research associate using Edmonton Frail scale and allocation concealment will be done by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be created by an independent statistician using ralloc.ado version 3.6.1 in Stata version 11.1. Treatment allocations will be randomly permuted and balanced within blocks and stratified according to gender. Numbered opaque envelopes will conceal allocation until baseline assessments have been completed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary research question will be evaluated via 2-arm parallel pre-test post-test, follow up RCT. Analysis of covariance will be used to evaluate the difference between mean change scores in each arm of the trial at post-test and follow up. Specialised software called PASS was used for sample size estimation implementing its “Tests for Two Groups of Pre-Post Scores“ procedure corresponding to the chosen analytical approach. The measure of FS was used as the primary outcome of interest in sample size estimation. Without prior pilot study undertaken, the paper by Ng et al provided SDs of FS for both time points (0.8 and 0.84) with alpha 0.05 and power 0.8 (Ng et al 2015). The difference between trial arms mean changes of 0.4 was proposed as effect size reflecting the results by Ng et al. The correlation between pre and post FS scores was hypothesised to be 0.7 which can be regarded as conservative given the nature of the measure. The PASS procedure estimated the total sample size needed to be 82 which after factoring 40% dropout rate shown in similar study resulted in 115 subjects to be randomised. 40% drop out rate was used instead of 30% due to the increase number of activities in this trial compared to the previous study done at the same location.

Variables will be tested for normality using sk test. Basic descriptive statistics will be used and continuous variables were expressed as mean values or median interquartile (IQR) ranges and will be compared using an appropriate parametric (Student’s t) test or non-parametric (Mann–Whitney U) tests. Categorical variables will be compared using and v2 statistics or Fishers exact test as appropriate. Edmonton frail scale scores will be defined as mean (SD) and paired student’s t test will be used to measure change in scores from the baseline and independent t-test will be applied to test differences in the scores between control and intervention groups at the end of intervention.

Logistic regression will be used to determine odds ratio by creating a new outcome variable (Edmonton frail scale –6-7 as pre-frail vs 8 as frail) in the two groups. All secondary outcomes variables will be defined as mean (SD) and paired Student’s t tests were used to measure change in scores from the baseline and Independent sample t-tests will be applied to test between group differences at the end of intervention. Regression analysis was applied to determine any differences in Quality of life in two groups with compliance with the intervention used as confounding variable.

Length of stay will be adjusted for in hospital mortality. Rank sum test will be used to compare the differences in Length of stay of two groups if this variable is normally distributed. Logistic regression will be used to determine odds of patients staying in hospital for more than 1 week by creating a new outcome variable for LOS (LOS 7 or less days or LOS more than 7 days). A Kaplan–Meier survival curve will be plotted, and Log rank test statistics will be used to evaluate the equality of survival distribution between control and intervention group. All tests will be 2-sided and a P value of less than 0.05 will be considered statistically significant. Statistical analyses will be performed using SPSS software (version 25).

Reference: Ng TP, Feng L, Nyunt MS, Feng L, Niti M, Tan BY, Chan G, Khoo SA, Chan SM, Yap P, Yap KB. Nutritional, physical, cognitive, and combination interventions and frailty reversal among older adults: a randomized controlled trial. The American journal of medicine. 2015 Nov 1;128(11):1225-36.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 14560 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 27575 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 303571 0
University
Name [1] 303571 0
Flinders University College of Nursing and Health Science Research Student Maintenance
Address [1] 303571 0
Flinders University, College of Nursing & Health Sciences, Sturt West Wing (W410), GPO Box 2100, Adelaide 5001, South Australia
Country [1] 303571 0
Australia
Primary sponsor type
University
Name
Flinders University, Department of Nutrition and Dietetics
Address
Flinders University, College of Nursing and Health, Health Sciences Building (N118), GPO Box 2100, Adelaide 5001, South Australia
Country
Australia
Secondary sponsor category [1] 303649 0
Hospital
Name [1] 303649 0
Flinders Medical Centre
Address [1] 303649 0
Department of General Medicine, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042
Country [1] 303649 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303858 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 303858 0
Ward 6C, Room 6A219
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Ethics committee country [1] 303858 0
Australia
Date submitted for ethics approval [1] 303858 0
25/09/2019
Approval date [1] 303858 0
Ethics approval number [1] 303858 0

Summary
Brief summary
This study aims to understand the impact of a nutrition-exercise intervention commenced early during an acute hospitalisation and continued for an extended period post-discharge on frailty. This study will test whether a multi-purpose intervention can be delivered by a trained allied health professional and if successful can have financial benefits in the current times of economic constraints. If found to be effective, it will create a streamlined service that can benefit the increasing population of frail elderly patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95042 0
Prof Michelle Miller
Address 95042 0
Flinders University, College of Nursing and Health, Health Sciences Building (N118)
GPO Box 2100, Adelaide 5001, South Australia
Country 95042 0
Australia
Phone 95042 0
+61 8 82012421
Fax 95042 0
Email 95042 0
michelle.miller@flinders.edu.au
Contact person for public queries
Name 95043 0
Mr Chad Han
Address 95043 0
Flinders University, College of Nursing and Health Sciences, Flinders Medical Centre (7E:105.4) GPO Box 2100, Adelaide 5001, South Australia
Country 95043 0
Australia
Phone 95043 0
+61 452091109
Fax 95043 0
Email 95043 0
chad.han@flinders.edu.au
Contact person for scientific queries
Name 95044 0
Mr Chad Han
Address 95044 0
Flinders University, College of Nursing and Health Sciences, Flinders Medical Centre (7E:105.4) GPO Box 2100, Adelaide 5001, South Australia
Country 95044 0
Australia
Phone 95044 0
+61 452091109
Fax 95044 0
Email 95044 0
chad.han@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No ethics approval sought for IDP to be available
What supporting documents are/will be available?
No other documents available
Summary results
No Results