Mobility in Older People

Frail Older People Undergoing Inpatient Rehabilitation Clinical Trial

— MOVE  

Official title:

Optimising Rehabilitation Outcomes in Frail Older Adults: Effects of Increasing the Amount of Physical Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01910740
• Other study ID #: NHMRC - 1042680
• Status: Completed
• Phase: N/A
• First received: July 22, 2013
• Last updated: May 31, 2016
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: La Trobe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Frail Older People Undergoing Inpatient Rehabilitation

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Australia	Heidelberg Repatriation Hospital, Austin Health	Heidelberg	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
La Trobe University	Austin Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Velocity	Gait velocity will be measured using the 6 metre walk test	Discharge (Average Duration of Hospital Stay is 3 weeks)	No
Secondary	Gait Velocity	Gait velocity will be measured using the 6 metre walk test	6 Months Follow Up (post discharge)	No