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A Twice-Daily Individual Targeted Exercise Program in Frail Hospitalised Older Medical In-patients (RCT)

NCT ID: NCT02463864

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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It is well known that older medical patients can experience functional decline following an acute hospital admission and this can persist for up to three months. The targeted exercises are designed to prevent this functional decline by maintaining the patients' strength, balance and endurance. To counterbalance the considerable time spent with the physiotherapy services in the intervention arm, the control group will receive stretches and relaxation exercises. Patients' length of stay is the primary outcome measure. Their physical performance and quality of life at discharge and at 3 months post discharge and their readmission rates are the secondary outcome measures.

Conditions

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Frail Older Adults

Keywords

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frailty older adult hospital exercise randomised control trial functional decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention exercise

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

Group Type EXPERIMENTAL

Intervention exercise

Intervention Type OTHER

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

Sham exercise

Twice daily, individual, stretching and relaxation exercise sessions

Group Type SHAM_COMPARATOR

Sham Exercise

Intervention Type OTHER

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

Interventions

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Intervention exercise

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

Intervention Type OTHER

Sham Exercise

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

Intervention Type OTHER

Other Intervention Names

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Augmented Prescribed Exercise Program

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College Cork

OTHER

Sponsor Role lead

Responsible Party

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Dr Suzanne Timmons

Senior Lecturer in Gerontology and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suzanne Timmons

Role: PRINCIPAL_INVESTIGATOR

University College Cork

Locations

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Mercy University Hospital

Cork, , Ireland

Site Status

Countries

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Ireland

References

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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.

Reference Type DERIVED
PMID: 32033532 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27059306 (View on PubMed)

Other Identifiers

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UCCork

Identifier Type: -

Identifier Source: org_study_id