CClinicalTrials.gg
CompletedNCT02463864APEPUpdated Nov 17, 2017

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

An interventional study of Intervention exercise and Sham Exercise in Frail Older Adults, sponsored by University College Cork. Completed at 1 site in Ireland. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2017-11-17.

Sponsored by University College Cork · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
65 Years and older
Sex
All
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Study 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.

Read the detailed description

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.

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Conditions studied

  • Frail Older Adults

Keywords

  • frailty
  • older adult
  • hospital
  • exercise
  • randomised control trial
  • functional decline
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In context

Lead sponsor

University College Cork is the lead sponsor of 116 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
190 participants (actual)

Study arms

  • Experimental
    Intervention exercise

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

    Other: Intervention exercise

  • Sham comparator
    Sham exercise

    Twice daily, individual, stretching and relaxation exercise sessions

    Other: Sham Exercise

Interventions

  • OtherIntervention exercise

    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

  • OtherSham Exercise

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

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What researchers measure

Primary outcomes

  1. Length of Stay

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

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

Secondary outcomes

  1. Physical Performance

    The Short Physical Performance Battery will be completed, which includes a timed 4 m walk. Patients can score 0-12; scoring higher with better physical performance.

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

  2. Quality of Life

    The EQ5D-5L will be completed by the patient.

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

  3. Re-admission Rate

    The number of admissions within 3 months following the index admission will be recorded from hospital electronic records

    Time frame: From the time of hospital discharge to 3 months post discharge

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Study locations

1 site
  • Mercy University Hospital
    Cork, 00, Ireland
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References and documents

Publications

  • 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. PubMed 32033532 ↗
  • 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. PubMed 27059306 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02463864
Lead sponsor
University College Cork
Responsible party
Dr Suzanne Timmons (Senior Lecturer in Gerontology and Rehabilitation, University College Cork) — Principal investigator
First posted
Jun 4, 2015
Start date
Mar 2015
Primary completion
Feb 2017
Completion
May 2017
Last update
Nov 17, 2017

Study contacts

Suzanne Timmons
principal investigator · University College Cork

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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