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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01910740




Registration number
NCT01910740
Ethics application status
Date submitted
22/07/2013
Date registered
30/07/2013
Date last updated
1/06/2016

Titles & IDs
Public title
Mobility in Older People
Scientific title
Optimising Rehabilitation Outcomes in Frail Older Adults: Effects of Increasing the Amount of Physical Activity
Secondary ID [1] 0 0
NHMRC - 1042680
Universal Trial Number (UTN)
Trial acronym
MOVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frail Older People Undergoing Inpatient Rehabilitation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Enhanced Physical Activity
Other interventions - Usual Care
Other interventions - Social Interaction

Experimental: Enhanced Physical Activity - Participants in the Enhanced Physical Activity group will receive a program of enhanced physical activity in addition to the usual care.

Active Comparator: Usual Care - The Usual Care group will receive usual therapy provided by a multidisciplinary team and social interaction.


Other interventions: Enhanced Physical Activity
Individually tailored programs focused on increasing the amount of time participants spend performing mobility activities, particularly standing and walking in the late afternoons and evenings and on weekends. These participants will be provided with one or two extra sessions on weekdays and two extra sessions on weekend days for the duration of their rehabilitation stay.

Other interventions: Usual Care
Therapy provided by a multidisciplinary team which includes physiotherapy and occupational therapy on weekdays with other allied health input (eg speech pathology, social work) as indicated. Medical and nursing care is also provided seven days a week.

Other interventions: Social Interaction
To control for the extra hours of physical activity that the experimental group receives, participants in the control group shall have additional activities such as card and board games, conversation or reading as well as upper limb exercises and other physical activities that have minimal impact on ambulant mobility.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Gait Velocity
Timepoint [1] 0 0
Discharge (Average Duration of Hospital Stay is 3 weeks)
Secondary outcome [1] 0 0
Gait Velocity
Timepoint [1] 0 0
6 Months Follow Up (post discharge)

Eligibility
Key inclusion criteria
- over 60 years of age

- a goal of admission is to 'improve weight-bearing mobility or improve walking' as
determined by either the admission referral or the treating therapist
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- specific medical restrictions that limit mobilisation (e.g. non weight bearing)

- if already enrolled in a different Randomised Controlled Trial

- previously enrolled in the current trial

- the primary reason for admission is awaiting a residential care placement

- the primary reason for admission is for carer training

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
198
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Heidelberg Repatriation Hospital, Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg

Funding & Sponsors
Primary sponsor type
Other
Name
La Trobe University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Austin Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The main aim of this study is to investigate whether increasing the amount of physical
activity in frail older people during hospital based rehabilitation is associated with better
mobility outcomes compared to usual care. A second aim is to investigate whether this
physical activity intervention is associated with improvements in health related quality of
life. Finally we plan to investigate whether increasing the amount of physical activity
during rehabilitation is cost effective, measured from a health system perspective, compared
with usual care.

Older people receiving inpatient rehabilitation will be randomly assigned to an intervention
group, who will receive extra physical activity on weekdays and weekends or a control group,
who will receive additional activities based on social interaction. The activity sessions
will be individualized to the particular participant. Both groups of people will be assessed
at baseline, discharge from hospital and at 6 months following discharge. The intervention
group will be provided with one or two extra sessions on weekdays and two extra sessions on
weekends for the duration of their rehabilitation stay. To account for the extra
physiotherapy time that the intervention group receives, the people in the control group will
spend the same amount of time performing other activities, such as cards, board games or
reading, whilst seated. To ensure the safety of the participants in this study, each physical
activity session will be supervised by either a physiotherapist or allied health assistant.

Hypothesis 1: The primary hypothesis is that, compared with usual care, increasing the amount
of physical activity in frail older people during rehabilitation will lead to more optimal
mobility at discharge, as measured by gait speed.

Secondary hypotheses are that, compared with usual care, increasing the amount of physical
activity during rehabilitation will:

Hypothesis 2: lead to significantly greater improvements in mobility and function both at
discharge and six months following discharge.

Hypothesis 3: lead to better quality of life six months following hospital discharge,
measured using the EuroQol Health (EQ5D) Questionnaire and the EuroQol-Visual Analogue Scale
(EQ-VAS).

Hypothesis 4: be cost effective compared to usual care
Trial website
https://clinicaltrials.gov/ct2/show/NCT01910740
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Meg Morris, PhD
Address 0 0
La Trobe University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01910740