Frail Older People Undergoing Inpatient RehabilitationMOVENCT01910740
Mobility in Older People
A study testing Enhanced Physical Activity and Social Interaction in people with Frail Older People Undergoing Inpatient Rehabilitation, run by La Trobe University at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frail Older People Undergoing Inpatient Rehabilitation
- What is being tested?
- Enhanced Physical Activity and Social Interaction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Heidelberg Repatriation Hospital, Austin Health
Heidelberg, Victoria, 3084
About this study
Official title: Optimising Rehabilitation Outcomes in Frail Older Adults: Effects of Increasing the Amount of Physical Activity
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.
Read more
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
- Being tested
- Enhanced Physical Activity, Usual Care, Social Interaction
- Keywords
- Randomized Controlled Trial, Exercise Movement Techniques, Frail Elderly, Gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Physical ActivityOther
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.
Usual CareOther
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.
Social InteractionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Physical Activity | Experimental | Participants in the Enhanced Physical Activity group will receive a program of enhanced physical activity in addition to the usual care. Receives: Other: Enhanced Physical Activity; Other: Usual Care |
| Usual Care | Active comparator | The Usual Care group will receive usual therapy provided by a multidisciplinary team and social interaction. Receives: Other: Usual Care; Other: Social Interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Velocity
Gait velocity will be measured using the 6 metre walk test
Measured: Discharge (Average Duration of Hospital Stay is 3 weeks)
Secondary outcomes (1)
Gait Velocity
Gait velocity will be measured using the 6 metre walk test
Measured: 6 Months Follow Up (post discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Frail Older People Undergoing Inpatient RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- La Trobe University
- Sponsor type
- University, hospital or other
- Collaborators
- Austin Health
- Responsible party
- Principal investigator, Meg Morris, La Trobe University
- Investigators
- Meg Morris, PhD, Principal investigator, La Trobe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910740
- Sponsor's protocol ID
- NHMRC - 1042680
- Acronym
- MOVE
- Status last verified
- May 2016
- First submitted
- 22 Jul 2013
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Said CM, McGinley JL, Szoeke C, Workman B, Hill KD, Wittwer JE, Woodward M, Liew D, Churilov L, Bernhardt J, Morris ME. Factors associated with improved walking in older people during hospital rehabilitation: secondary analysis of a randomized controlled trial. BMC Geriatr. 2021 Jan 31;21(1):90. doi: 10.1186/s12877-021-02016-0.
PubMed 33517882Said CM, Morris ME, McGinley JL, Szoeke C, Workman B, Liew D, Hill K, Woodward M, Wittwer JE, Churilov L, Ventura C, Bernhardt J. Evaluating the effects of increasing physical activity to optimize rehabilitation outcomes in hospitalized older adults (MOVE Trial): study protocol for a randomized controlled trial. Trials. 2015 Jan 15;16:13. doi: 10.1186/s13063-014-0531-y.
PubMed 25588907
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Rehabilitation Outcomes in Frail Older Adults: Effects of Increasing the Amount of Physical Activity
- ClinicalTrials.gov ID
- NCT01910740
- Acronym / sponsor ID
- MOVE / NHMRC - 1042680
- Keywords
- Randomized Controlled Trial, Exercise Movement Techniques, Frail Elderly, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- La Trobe UniversityUniversity, hospital or other
- Collaborators
- Austin Health
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Physical Activity | Experimental | Other: Enhanced Physical Activity, Other: Usual CareParticipants in the Enhanced Physical Activity group will receive a program of enhanced physical activity in addition to the usual care. |
| Usual Care | Active comparator | Other: Usual Care, Other: Social InteractionThe Usual Care group will receive usual therapy provided by a multidisciplinary team and social interaction. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Physical ActivityIndividually 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 | Enhanced Physical Activity |
| Usual CareTherapy 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 | Enhanced Physical Activity, Usual Care |
| Social InteractionTo 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. | Other | Usual Care |
Primary outcome
Gait Velocity
Time frame: Discharge (Average Duration of Hospital Stay is 3 weeks)
Gait velocity will be measured using the 6 metre walk test
1 secondary outcome
Gait Velocity
Time frame: 6 Months Follow Up (post discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Derived from this study: PubMed 33517882Said CM, McGinley JL, Szoeke C, Workman B, Hill KD, Wittwer JE, Woodward M, Liew D, Churilov L, Bernhardt J, Morris ME. Factors associated with improved walking in older people during hospital rehabilitation: secondary analysis of a randomized controlled trial. BMC Geriatr. 2021 Jan 31;21(1):90. doi: 10.1186/s12877-021-02016-0.
- Derived from this study: PubMed 25588907Said CM, Morris ME, McGinley JL, Szoeke C, Workman B, Liew D, Hill K, Woodward M, Wittwer JE, Churilov L, Ventura C, Bernhardt J. Evaluating the effects of increasing physical activity to optimize rehabilitation outcomes in hospitalized older adults (MOVE Trial): study protocol for a randomized controlled trial. Trials. 2015 Jan 15;16:13. doi: 10.1186/s13063-014-0531-y.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meg Morris, PhD principal investigator
La Trobe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Physical Activity and Social Interaction in people with Frail Older People Undergoing Inpatient Rehabilitation, run by La Trobe University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Velocity (time frame: Discharge (Average Duration of Hospital Stay is 3 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01910740, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016; AzTrials last refreshed its copy on 29 Oct 2026.