Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001367134
Ethics application status
Approved
Date submitted
20/09/2019
Date registered
8/10/2019
Date last updated
6/03/2023
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, quality of life in hospitalised older 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 prior qualitative study of frail and pre-frail hospitalised older adults (n=22) was conducted at the research site to inform the intervention protocol. Intervention participants will receive 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. Results from the qualitative study also informed that diet intervention to involve meeting the recommendations of food groups and hydration in the Australian Guide to Healthy Eating (AGHE). Protein intake was a key in the previously described diet intervention. The research team decided to set a specific recommendation for protein intake (1-1.2g/kg body weight/d) to maintain and regain lean body mass based on guidelines (Bauer et al 2013).
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.
As informed by a prior qualitative study of frail and pre-frail hospitalised older adults (n=22) conducted, walking will be added to inpatient exercise session daily. Patient will be given a chance and encouraged to walk for 10 minutes, or as tolerated based on individual tolerance, with the allied health assistant to ensure safety. Inpatient exercise session will last approximately 20 minutes, inclusive of walking time.
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
Bauer J, Biolo G, Cederholm T, Cesari M, Cruz-Jentoft AJ, Morley JE, et al. Evidence-based recommendations for optimal dietary protein intake in older people: a position paper from the PROT-AGE Study Group. J Am Med Dir Assoc. 2013;14(8):542-59.
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 English instructions (MMSE score above 24)
• 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
• admitted to a long stay unit from the Acute medical unit
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Receiving palliative care
• Living outside of the SALHN areas
• On home oxygen
• Assessed by research medical doctor as unsafe to participate

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 researcher (not involved in the study) through computerised randomisation. Treatment allocations will be randomly permuted and balanced within blocks of 8. 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
Sample size calculation
The sample size for the study was based on the primary outcome of interest, the EFS measure of frailty. Based on previous data that estimated a mean difference between intervention and control arms of 0.4 or more and a within-group SD of approximately 0.8,33 a correlation between pre and post frailty scores of 0.7, and an ANOVA repeated measures approach to the analysis, a sample size of n=43 subjects per arm will provide 80% power assuming a 2-sided Type 1 error rate of alpha=0.05. Allowing for a dropout rate of 25%, to allow for the extended length of the study, a sample size of n=58 per arm will be recruited (Figure 1.).

Randomisation and blinding
After consent, screening, enrolment and baseline assessments, the research staff will send an identification number to the central research office, and the participant will be randomised into either intervention or control group. The randomisation schedule will be created by the study statistician through computerised randomisation using randomly permuted blocks of size 8. Treatment codes will be concealed in numbered opaque envelopes and opened by a research staff member at the time of randomisation. Therapists and participants will be aware of the allocated group, as it is not possible to blind the participants or research staff administering the intervention due to the nature of the intervention in this trial. However, research staff performing outcome assessments and data analyses will be blinded to group allocation.

Statistical Analysis - Treatment groups will be coded in order to blind statisticians prior to analyses. Baseline data will be described and compared with the use of t-tests or Mann-Whitney U Tests for continuous data and chi square or Fisher’s exact test, for categorical data. The primary analyses will be conducted with intention-to-treat principles with all subjects randomised included in the analysis and assigned to the group they were randomised to regardless of their received treatment.46 Primary and secondary outcomes will be analysed with the use of generalised linear mixed effects models and include, group, time, and group X time interaction terms as fixed effects and a random intercept for the subject. For time to event outcomes including mortality and hospital readmission, Kaplan-Meier curves will be used to describe the estimated survival times for the 2 groups which will be compared using log-rank tests and Cox regression. Statistical significance will be set using a 2-sided Type 1 error rate of alpha=0.05 and differences between groups at three-month and six-month follow-up will be described using the mean (95% confidence interval) or percentage change. These differences will be determined using the group X time interaction terms and will only be considered significant at p<0.05 if the overall interaction term is also significant in order to adjust for the use of 2 separate comparisons.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
Other reasons
COVID restrictions in high risk places i.e., inpatient wards.
Date of first participant enrolment
Anticipated
9/01/2020
Actual
1/09/2020
Date of last participant enrolment
Anticipated
9/03/2021
Actual
1/06/2021
Date of last data collection
Anticipated
6/09/2021
Actual
7/01/2022
Sample size
Target
116
Accrual to date
Final
32
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
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
Approved
Ethics committee name [1] 303858 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 303858 0
Ethics committee country [1] 303858 0
Australia
Date submitted for ethics approval [1] 303858 0
25/09/2019
Approval date [1] 303858 0
04/12/2019
Ethics approval number [1] 303858 0

Summary
Brief summary
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
[email protected]
Contact person for public queries
Name 95043 0
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
[email protected]
Contact person for scientific queries
Name 95044 0
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
[email protected]

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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIndividualized Hospital to Home, Exercise-Nutrition Self-Managed Intervention for Pre-Frail and Frail Hospitalized Older Adults: The INDEPENDENCE Randomized Controlled Pilot Trial.2023https://dx.doi.org/10.2147/CIA.S405144
N.B. These documents automatically identified may not have been verified by the study sponsor.