Clinical trial NCT01910740: Mobility in Older People
Official title: Optimising Rehabilitation Outcomes in Frail Older Adults: Effects of Increasing the Amount of Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Older People Undergoing Inpatient Rehabilitation
Keywords: Randomized Controlled Trial
Exercise Movement Techniques
Frail Elderly
Gait
Lead sponsor: La Trobe University
Sponsor class: OTHER
Collaborators: name: Austin Health
First posted: 2013-07-30
Enrollment: 198
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

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

Primary outcomes:
measure: Gait Velocity
timeFrame: Discharge (Average Duration of Hospital Stay is 3 weeks)
Secondary outcomes:
measure: Gait Velocity
timeFrame: 6 Months Follow Up (post discharge)
Other outcomes:
Locations:
city: Heidelberg
country: Australia
facility: Heidelberg Repatriation Hospital, Austin Health
state: Victoria
Study officials:
affiliation: La Trobe University
name: Meg Morris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Said 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.