NCT01910740

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

1.9 years

First QC Date

July 22, 2013

Last Update Submit

May 31, 2016

Conditions

Frail Older People Undergoing Inpatient Rehabilitation

Keywords

Randomized Controlled TrialExercise Movement TechniquesFrail ElderlyGait

Outcome Measures

Primary Outcomes (1)

  • Gait Velocity

    Gait velocity will be measured using the 6 metre walk test

    Discharge (Average Duration of Hospital Stay is 3 weeks)

Secondary Outcomes (1)

  • Gait Velocity

    6 Months Follow Up (post discharge)

Study Arms (2)

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.

Other: Enhanced Physical ActivityOther: Usual Care

Usual Care

ACTIVE COMPARATOR

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

Other: Usual CareOther: Social Interaction

Interventions

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.

Enhanced Physical Activity
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.

Enhanced Physical ActivityUsual Care
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.

Usual Care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heidelberg Repatriation Hospital, Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Related Publications (2)

  • 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.

    PMID: 33517882DERIVED

  • 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.

    PMID: 25588907DERIVED

MeSH Terms

Interventions

Drug Interactions

Intervention Hierarchy (Ancestors)

Pharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

Study Officials

  • Meg Morris, PhD

    La Trobe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Meg Morris

Study Record Dates

First Submitted

July 22, 2013

First Posted

July 30, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

AU(1)