NCT02463864

Brief Summary

This study will help to determine whether frail older medical inpatients will benefit from targeted exercise sessions performed twice daily while in hospital. Half of the patients will complete targeted strengthening, balance and endurance exercises and the other half, stretching and relaxation exercises. The exercise sessions will be assisted and supported by a senior physiotherapist.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1.9 years

First QC Date

May 26, 2015

Last Update Submit

November 14, 2017

Conditions

Frail Older Adults

Keywords

frailtyolder adulthospitalexerciserandomised control trialfunctional decline

Outcome Measures

Primary Outcomes (1)

  • Length of Stay

    Patients length of hospital stay is recorded at the time of discharge from electronic admissions data

    At time of discharge from hospital (an expected average of 8 days post admission)

Secondary Outcomes (3)

  • Physical Performance

    At time of discharge from hospital (an expected average of 8 days post admission); and again at 3 months post discharge

  • Quality of Life

    At time of discharge from hospital (an expected average of 8 days post admission); and again at 3 months post discharge

  • Re-admission Rate

    From the time of hospital discharge to 3 months post discharge

Study Arms (2)

Intervention exercise

EXPERIMENTAL

Twice daily, individual, targeted, strengthening, balance and endurance exercise sessions

Other: Intervention exercise

Sham exercise

SHAM COMPARATOR

Twice daily, individual, stretching and relaxation exercise sessions

Other: Sham Exercise

Interventions

Intervention exerciseOTHER

Twice daily, individual, targeted, strengthening, balance and endurance exercises for the duration of the hospital stay, prescribed and delivered by a senior physiotherapist.

Also known as: Augmented Prescribed Exercise Program
Intervention exercise
Sham ExerciseOTHER

Twice daily stretching and relaxation exercises for the duration of the hospital stay, by a senior physiotherapist.

Sham exercise

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • medical patients
  • anticipated length of stay greater than 2 days
  • planned for discharge home
  • mobility aid and /or assistance required on admission

You may not qualify if:

  • contraindications to exercise
  • unable to follow commands in the English language
  • unable to exercise with the assistance of one person only
  • when active palliative care is required
  • when full isolation for containment of a contagious infection is required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mercy University Hospital

Cork, 00, Ireland

Location

Related Publications (2)

  • McCullagh R, O'Connell E, O'Meara S, Dahly D, O'Reilly E, O'Connor K, Horgan NF, Timmons S. Augmented exercise in hospital improves physical performance and reduces negative post hospitalization events: a randomized controlled trial. BMC Geriatr. 2020 Feb 7;20(1):46. doi: 10.1186/s12877-020-1436-0.

    PMID: 32033532DERIVED

  • McCullagh R, O'Connell E, O'Meara S, Perry I, Fitzgerald A, O'Connor K, Horgan NF, Timmons S. A study protocol of a randomised controlled trial to measure the effects of an augmented prescribed exercise programme (APEP) for frail older medical patients in the acute setting. BMC Geriatr. 2016 Apr 8;16:79. doi: 10.1186/s12877-016-0252-z.

    PMID: 27059306DERIVED

MeSH Terms

Conditions

FrailtyMotor Activity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Suzanne Timmons

    University College Cork

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Gerontology and Rehabilitation

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 4, 2015

Study Start

March 1, 2015

Primary Completion

February 1, 2017

Study Completion

May 1, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

IE(1)