Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000692730p
Ethics application status
Submitted, not yet approved
Date submitted
22/04/2022
Date registered
12/05/2022
Date last updated
12/05/2022
Date data sharing statement initially provided
12/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of an early individualised targeted exercise protocol “STAY FIT in HOSPITAL” in preventing Hospital Associated Deconditioning
Scientific title
Evaluating the effectiveness of an early individualised targeted exercise protocol in preventing Hospital Associated Deconditioning as a sarcopenia intervention, a pilot randomised controlled trial of efficacy and feasibility
Secondary ID [1] 306985 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospital Associated Deconditioning 326100 0
Sarcopenia 326127 0
Condition category
Condition code
Musculoskeletal 323414 323414 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: tailored exercise program
The patients will be randomly assigned to a tailored exercise program or to usual care. The exercise program for the intervention group will be implemented by the study physiotherapist and the assistant physiotherapist. The main focus will be on strength training (progressive resistance exercises) with an intensity enough to improve/maintain the lower limb strength. The main exercise equipment will be an electric mini pedal exercise bike Monark 881E ergometer with variable resistance. This is a portable machine and can be taken to study participants and can be easily administered whilst the participant is safely sitting down in a chair. The settings can be adjusted for progressively increased resistance (watts) and rpm can be monitored. The proposed exercise program will be be carefully chosen for the patient. The exercises can be performed sitting down or lying down in bed, which is most suited to our patient cohort.
The recommendations as per the American College of Sports Medicine guidelines were followed in formulating the exercise program. The guidelines recommend using a high-intensity, low-to-moderate repetition maximum (RM), with completion of 10-15 repetitions for older and /or more frail participants. Progressive resistance training exercise using leg pedal ergometer, 5 days/week (morning session), start at 40-50% 1RM and gradually work up to 60-80% over the period of 7 days, 1 set of 10-12 repetition, 2 sets of light intensity with rest breaks of 10 minutes. Those participants unable to get out of bed or not tolerating the pedal exercise bike will be offered quadriceps strengthening exercises with weighted cuffs, progressively achieving 70-80% of 1 Repetition maximum. Dumbbells will be used to maintain upper limb strength for all participants and this will be offered as the second session of exercises (afternoon).
Morning session will be about 40 minutes in duration and afternoon session about 20 minutes duration.
The intervention group will also receive the usual care (once daily sit to stand practice and mobility training with the ward physiotherapist).
A record of the exercises will be kept by the physiotherapists (study and usual care) as to the type of exercises, sets of repeats, intensity and duration. This will be used to monitor the acceptance and adherence to the intervention.
Sample size Based on the previous studies a total of 150 patients (75 in each group) will give 90% power ) to detect a change in the FIM score at 7 days from -30 units in the usual care group to -15 units in the exercise intervention group (based on SD of 25 units which is a conservative estimate from our previous study). This allows 20% non- compliance. For this pilot study we will be aiming to recruit 50 patients using the same study protocols.
Intervention code [1] 323424 0
Rehabilitation
Comparator / control treatment
The control group participants will only receive the usual care by the ward physiotherapists. This includes once daily sit to stand practise and mobility training with the ward physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 331153 0
The primary outcome measure will include mobility and functional assessments at baseline and at the completion of the intervention (seven days of receiving intervention). .

1. FIM functional independence measure The Functional Independence Measure (FIM), is a validated tool with an 18-item, 7-level scale developed to uniformly assess severity of patient disability and rehabilitation functional outcomes. The 18 items are divided into two major groups: motor (13 items) and cognitive (5 items). The activity that are evaluated include self-care activities (grooming, bathing, dressing, and toileting), bowel and bladder control, transfers, mobility, communication, and social cognition. The 7- level scale allows to classify the individual’s ability to carry out above activity independently versus need for differing levels of assistance.

Timepoint [1] 331153 0
Time point
FIM (functional independence measure); Measurements at Baseline and after receiving 7 days of intervention.
Primary outcome [2] 331188 0
2. The de Morton Mobility Index (DEMMI) This is a validated instrument that captures the mobility statue of older acute medical patients, with assessment of bed mobility, sit to stand, walking, static and dynamic balance. The change in the DEMMI score from baseline to 7 days of intervention will be assessed. A change of 10 points is considered as minimally clinically important in the DEMMI score.
Timepoint [2] 331188 0
Time point
The de Morton Mobility Index (DEMMI) will be measured at Base line and after receiving 7 days of intervention.
Secondary outcome [1] 409020 0
1. Muscle strength: Grip strength in the dominant limb will be measured by a handheld dynamometer.



Timepoint [1] 409020 0
Muscle strength measurements will be taken at baseline and after receiving 7 days of intervention.
Secondary outcome [2] 409113 0
2. Gait velocity (GV; m/s): Habitual gait velocity will be measured with a 4 meter walk test
Timepoint [2] 409113 0
Gait velocity (GV; m/s) measurements will be recorded at Baseline and after receiving 7 days of intervention.
Secondary outcome [3] 409114 0
3, Sarcopenia: SARC-F is a simple questionnaire to rapidly assess for Sarcopenia using a questionnaire
Timepoint [3] 409114 0
Sarcopenia: SARC-F questionnaire at baseline, after receiving 7 days of intervention and at three months from the hospital admission.
Secondary outcome [4] 409115 0
4. Adherence to the study will be monitored by a study diary record as to the participation for each session during the intervention period of 7 days by the study physiotherapist or assistant physiotherapist
Timepoint [4] 409115 0
The compliance with the participation in the exercise program exercise program will be recorded for each session in a study diary while receiving the 7 days of intervention.
Secondary outcome [5] 409116 0
5. QOL: EQ-5D is a health-related quality of life measure, widely used in health economic evaluation.
Timepoint [5] 409116 0
QOL: EQ-5D evaluation after receiving 7 days of intervention and at three months from the hospital admission.
Secondary outcome [6] 409117 0
6. Number of falls: The number of falls will be monitored by reviewing the medical records and participants self report.
Timepoint [6] 409117 0
Number of falls at baseline (previous 12 months), after receiving 7 days of intervention and at three months from the hospital admission.
Secondary outcome [7] 409118 0
7. Hospital length of stay (LOS) will be assessed by data-linkage to medical records. The Hospital LOS will include acute and subacute bed days and will be utilized to evaluate the cost effectiveness of the intervention.
Timepoint [7] 409118 0
Hospital length of stay will be determined at 3 months review (from hospital admission)
Secondary outcome [8] 409119 0
8. Adverse effects related to the exercise program: A record of injury, exacerbation of pain, falls related to the exercise program and premature cessation of the intervention will be recorded on a daily basis in a study diary by the study physiotherapist or assistant physiotherapist during the intervention period of 7 days
Timepoint [8] 409119 0
Adverse effects related to exercise program will be recorded daily in a study diary while receiving the 7 days of intervention.
Secondary outcome [9] 409333 0
Isometric knee extension strength of the dominant limb will be assesses using a belt-stabilised handheld dynamometer
Timepoint [9] 409333 0
Muscle strength measurements will be taken at baseline and after receiving 7 days of intervention.

Eligibility
Key inclusion criteria
The eligible participant for this study will be patients 65 years and older ambulatory community dwellers, admitted to hospital for management of acute medical condition/s and who do not have a cognitive impairment that would stop them providing informed consent and are able to follow instructions.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria include new onset focal neurological deficits, unstable cardiac and or respiratory disease, potential short admissions of less than 7 days, and acute onset musculoskeletal injuries with pain significantly limiting functioning.


Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using randomisation table created by computer software
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
For descriptive purposes, mean values and standard deviations will be used for normally distributed data, and range and medians for data with a skewed distribution. For comparison between groups, student's t-test will be used or a Mann-Whitney U-test. For comparison between follow-up measurements, a paired t-test or Wilcoxon signed rank test will also be used for each group. If there are differences in baseline characteristics between the intervention and control groups analysis of covariance (ANCOVA) will be used to adjust for these differences. Timeline For this pilot study we would expect to recruit total of 50 participants. The assessments will need about 9 months to complete.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2022
Actual
Date of last participant enrolment
Anticipated
30/03/2023
Actual
Date of last data collection
Anticipated
30/07/2023
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22227 0
Hawkesbury District Health Service - Windsor
Recruitment postcode(s) [1] 37391 0
2756 - Windsor

Funding & Sponsors
Funding source category [1] 311296 0
Charities/Societies/Foundations
Name [1] 311296 0
RACP 2022 Research Entry Scholarship
Country [1] 311296 0
Australia
Primary sponsor type
Individual
Name
Dr Pushpa Suriyaarachchi
Address
Dept of Rehabilitation Medicine
Nepean Hospital, Derby Street, KIngswood, NSW 2747
Country
Australia
Secondary sponsor category [1] 312659 0
None
Name [1] 312659 0
Address [1] 312659 0
Country [1] 312659 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310799 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 310799 0
Ethics committee country [1] 310799 0
Australia
Date submitted for ethics approval [1] 310799 0
07/04/2022
Approval date [1] 310799 0
Ethics approval number [1] 310799 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118910 0
Dr Pushpa Suriyaarachchi
Address 118910 0
Department of Rehabilitation Medicine
Nepean Hospital, Derby Street, Kingswood, NSW Australia 2747
Country 118910 0
Australia
Phone 118910 0
+61 02 47343930
Fax 118910 0
Email 118910 0
[email protected]
Contact person for public queries
Name 118911 0
Pushpa Suriyaarachchi
Address 118911 0
Department of Rehabilitation Medicine
Nepean Hospital, Derby Street, Kingswood, NSW Australia 2747
Country 118911 0
Australia
Phone 118911 0
+61 02 47343930
Fax 118911 0
Email 118911 0
[email protected]
Contact person for scientific queries
Name 118912 0
Pushpa Suriyaarachchi
Address 118912 0
Department of Rehabilitation Medicine
Nepean Hospital, Derby Street, Kingswood, NSW Australia 2747
Country 118912 0
Australia
Phone 118912 0
+61 02 47343930
Fax 118912 0
Email 118912 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
Not consented for data sharing


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
No additional documents have been identified.