An interventional study of Enhanced Physical Activity and Usual Care in Frail Older People Undergoing Inpatient Rehabilitation, sponsored by La Trobe University. Completed at 1 site in Australia. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2016-06-01.
Sponsored by La Trobe University · Not applicable, Interventional, and Treatment
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
La Trobe University is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Participants in the Enhanced Physical Activity group will receive a program of enhanced physical activity in addition to the usual care.
Other: Enhanced Physical Activity · Other: Usual Care
The Usual Care group will receive usual therapy provided by a multidisciplinary team and social interaction.
Other: Usual Care · Other: Social Interaction
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.
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.
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.
Gait Velocity
Gait velocity will be measured using the 6 metre walk test
Time frame: Discharge (Average Duration of Hospital Stay is 3 weeks)
Gait Velocity
Gait velocity will be measured using the 6 metre walk test
Time frame: 6 Months Follow Up (post discharge)
The record gives a start of Jan 2014, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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