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Trial registered on ANZCTR


Registration number
ACTRN12617001026314
Ethics application status
Approved
Date submitted
6/07/2017
Date registered
17/07/2017
Date last updated
26/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Measurement of Physical Activity during General Inpatient Rehabilitation
Scientific title
Efficacy of hospital-based interventions to increase physical activity in patients on a general rehabilitation ward
Secondary ID [1] 292370 0
None
Universal Trial Number (UTN)
U1111-1198-9753
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 303916 0
Orthopaedic conditions - joint replacement 303917 0
Orthopaedic conditions - fracture(s) 303918 0
Deconditioning 303919 0
Lower limb amputation 303920 0
Brain dysfunction 303921 0
Neurological conditions 303922 0
Arthritis 303923 0
Pain syndromes 303924 0
Orthopaedic conditions - all other 303925 0
Cardiac conditions 303926 0
Pulmonary conditions 303927 0
Major Multiple Trauma 303928 0
Spinal Cord Dysfunction 303929 0
Condition category
Condition code
Physical Medicine / Rehabilitation 303281 303281 0 0
Physiotherapy
Physical Medicine / Rehabilitation 303282 303282 0 0
Occupational therapy
Physical Medicine / Rehabilitation 303283 303283 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group
The study intervention is to implement changes in ward practices and culture to increase the physical activity of participants during inpatient rehabilitation. Interventions aimed at increasing participant’s physical activity on the rehabilitation ward. The interventions - specific frequency and components - are determined by the treating physiotherapist based on participant preference and level of physical function. The interventions will include, but not be limited to, current inpatient rehabilitation standard care plus having meals (breakfast, lunch and dinner) in a common dining room; walking a lap of the ward prior to attendance in the dining room or therapy gym; increased group therapy (balance, community access and gardening) during the week; and increased therapy on weekends (individual and group exercise sessions). Balance groups will occur three times a week, at least one of which will be in addition to the current exercise group and community access groups will occur weekly.

Materials
Participants who consent to participate in the study will have an activity monitor (ActivPAL micro) attached to their thigh with a water proof dressing, preferably on the less disabled lower limb. The activity monitor will be removed and reapplied weekly, so that data can be uploaded onto computer and the activity monitor can be recharged. This will be repeated until the participant has been discharged from inpatient rehabilitation.

Rehabilitation/procedures/activities
Participants will undergo rehabilitation. As a consequence, they may be involved in a number of activities delivered by a multidisciplinary team. Medical ward rounds, meals and activities (education sessions, games, Diversional Therapy) in the dining room, group therapy, individual therapy sessions delivered by allied health disciplines.

Who will deliver the intervention
All members of the rehabilitation team (medical, nursing and allied health) will deliver interventions that aim to increase each participant’s standing and walking time. For example, based on the level of physical function of participants as assessed by the treating physiotherapist, will be encouraged by staff to walk a lap of the ward prior to and following attendance in the dining room (for meals and/or education sessions) or the therapy room/gym. In addition, participant’s therapy schedule will be on a centralised timetable mounted on a wall (within the ward) that participants will be able to view by walking to view the timetable. This timetable will be completed by the rehabilitation team. Furthermore, additional groups will be run by physiotherapists, allied health assistants and /or occupational therapists such as - but not limited to - balance, community access, and gardening groups. Finally, therapy will also occur on weekends delivered by physiotherapists and/or physiotherapy assistants for approximately a total of 24 hours over the weekend.

Mode of delivery
Some therapy will occur in as individual sessions and others will be in the form of group therapy.

Dosage/duration/intensity
The intervention will occur during the participant’s inpatient rehabilitation admission. There will not be any specific dose, duration or intensity. Participants will be treated by physiotherapists and/or the physiotherapy assistant at least daily, often twice daily, in individual and/or group sessions.

Location
Inpatient rehabilitation ward
Intervention code [1] 298543 0
Rehabilitation
Comparator / control treatment
Control group
Current inpatient rehabilitation standard care. This involves assessment and management by the multidisciplinary team (medical, nursing and allied health). Specifically, interventions such as strengthening exercises, group exercise classes, weekly garden group and breakfast club, upper limb therapy, lunch in the dining room for less than half the ward and weekend physiotherapy of up to 16 hours (individual and group exercise sessions).

Materials
Participants who consent to participate in the study will have an activity monitor (ActivPAL micro) attached to their thigh with a water proof dressing, preferably on the less disabled lower limb. The activity monitor will be removed and reapplied weekly, so that data can be uploaded onto computer and the activity monitor can be recharged. This will be repeated until the participant has been discharged from inpatient rehabilitation.

Rehabilitation/procedures/activities
Participants will be undergoing rehabilitation. As a consequence, they may be involved in a number of activities delivered by a multidisciplinary team. Medical ward rounds, meals and activities (education sessions, games, Diversional Therapy) in the dining room, group therapy, individual therapy sessions delivered by allied health disciplines.

Who will deliver the control intervention
Current inpatient rehabilitation practice involves therapy delivered by allied health practitioners (occupational therapists, physiotherapists, physiotherapy assistant, speech pathologists and dietitians).

Mode of delivery
Currently, therapy occurs in as individual sessions and/or group therapy. Specifically, physiotherapy groups occur daily (Monday to Friday) and a garden group occurs weekly.

Dosage/duration/intensity
Current therapy practice will occur during the participant’s inpatient rehabilitation admission. There will not be any specific dose, duration or intensity. Participants will be treated by physiotherapists and/or the physiotherapy assistant at least daily, often twice daily, in individual and/or group sessions.

Location
Inpatient rehabilitation ward
Control group
Active

Outcomes
Primary outcome [1] 302665 0
Step count using activity monitors (ActivPAL micros) taped to the less disabled lower limb during the participant's admission.
Timepoint [1] 302665 0
Five days post admission
Secondary outcome [1] 336711 0
Change in the motor component of the Functional Independence Measure (m-FIM)
Timepoint [1] 336711 0
Admission and discharge (m-FIM)
Secondary outcome [2] 336712 0
Inpatient length of stay utilising data from the Sydney Local Health District Performance Unit
Timepoint [2] 336712 0
Admission and discharge dates
Secondary outcome [3] 336713 0
Change in sedentary, standing and stepping time using activity monitors (ActivPAL micros) taped to the less disabled lower limb during the participant's admission.
Timepoint [3] 336713 0
Admission and discharge dates
Secondary outcome [4] 336714 0
Change in the number of transitions (sit to stands) using activity monitors (ActivPAL micros) taped to the less disabled lower limb during the participant's admission.
Timepoint [4] 336714 0
Admission and discharge dates
Secondary outcome [5] 336715 0
Change in cadence using activity monitors (ActivPAL micros) taped to the less disabled lower limb during the participant's admission.
Timepoint [5] 336715 0
Admission and discharge dates

Eligibility
Key inclusion criteria
People admitted to the inpatient rehabilitation ward
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who are unable to consent, or who's valued other (family, carer, guardian) is unable to consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Prospective pre-post study.
This research will compare current practice, with changes in ward practice aimed at increasing physical activity
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participant numbers: 322 (161 in each group)

The typical improvement in step count across the first 5 days of an admission with current management is approximately 482 steps. We consider that an additional improvement in step count of 400 steps would make the intervention worthwhile. We calculate that a sample size of 322 participants (161 per group) will be sufficient to identify a treatment effect on improvement in step count of 400 steps or more as statistically significant, given:
- an anticipated SD of 1176 (based on an audit of activity monitor data for 97 patients from the unit);
- power of 80% and a statistical significance threshold of 0.05;
- worst-case loss to follow-up rate of 15%.

Data will be analysed using the statistics software package SPSS. For outcomes with normally distributed data, we will perform an ANOVA with adjustment for baseline values and any other strongly associated variables as covariates. If the data are not normally distributed we will use a non-parametric equivalent.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2017
Actual
3/08/2017
Date of last participant enrolment
Anticipated
31/05/2019
Actual
Date of last data collection
Anticipated
1/07/2019
Actual
Sample size
Target
322
Accrual to date
161
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8487 0
Balmain Hospital - Balmain
Recruitment postcode(s) [1] 16574 0
2041 - Balmain

Funding & Sponsors
Funding source category [1] 296923 0
Hospital
Name [1] 296923 0
Balmain Hospital
Country [1] 296923 0
Australia
Primary sponsor type
Individual
Name
Sandeep Gupta
Address
Balmain Hospital
29 Booth St
Balmain NSW 2041
Country
Australia
Secondary sponsor category [1] 295929 0
None
Name [1] 295929 0
Address [1] 295929 0
Country [1] 295929 0
Other collaborator category [1] 279632 0
Individual
Name [1] 279632 0
Dr Indu Nair
Address [1] 279632 0
Balmain Hospital
29 Booth St
Balmain NSW 2041
Country [1] 279632 0
Australia
Other collaborator category [2] 279633 0
Individual
Name [2] 279633 0
Jane Linton
Address [2] 279633 0
Balmain Hospital
29 Booth St
Balmain NSW 2041
Country [2] 279633 0
Australia
Other collaborator category [3] 279634 0
Individual
Name [3] 279634 0
Bridget Canham
Address [3] 279634 0
Balmain Hospital
29 Booth St
Balmain NSW 2041
Country [3] 279634 0
Australia
Other collaborator category [4] 279635 0
Individual
Name [4] 279635 0
Garry Jones
Address [4] 279635 0
Balmain Hospital
29 Booth St
Balmain NSW 2041
Country [4] 279635 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298129 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 298129 0
Ethics committee country [1] 298129 0
Australia
Date submitted for ethics approval [1] 298129 0
25/04/2017
Approval date [1] 298129 0
22/06/2017
Ethics approval number [1] 298129 0
AU/1/007D218; X17-0132; HREC/17/RPAH/195

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1867 1867 0 0
/AnzctrAttachments/373259-Ethics Approval letter.pdf (Ethics approval)
Attachments [2] 1868 1868 0 0
/AnzctrAttachments/373259-Master Protocol - Physical activity.docx (Protocol)
Attachments [3] 1869 1869 0 0
/AnzctrAttachments/373259-Master Consent Form Participant- Physical Activity.doc (Participant information/consent)
Attachments [4] 1870 1870 0 0
/AnzctrAttachments/373259-Master Information for Participants V1.1- Physical activity.doc (Participant information/consent)

Contacts
Principal investigator
Name 76094 0
Mr Sandeep Gupta
Address 76094 0
Balmain Hospital
29 Booth St
Balmain NSW 2041
Country 76094 0
Australia
Phone 76094 0
+61 2 9395 2099
Fax 76094 0
+61 2 9395 2119
Email 76094 0
Sandeep.Gupta@sswahs.nsw.gov.au
Contact person for public queries
Name 76095 0
Sandeep Gupta
Address 76095 0
Balmain Hospital
29 Booth St
Balmain NSW 2041
Country 76095 0
Australia
Phone 76095 0
+61 2 9395 2099
Fax 76095 0
+61 2 9395 2119
Email 76095 0
Sandeep.Gupta@sswahs.nsw.gov.au
Contact person for scientific queries
Name 76096 0
Sandeep Gupta
Address 76096 0
Balmain Hospital
29 Booth St
Balmain NSW 2041
Country 76096 0
Australia
Phone 76096 0
+61 2 9395 2099
Fax 76096 0
+61 2 9395 2119
Email 76096 0
Sandeep.Gupta@sswahs.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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