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

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ClinicalTrials.gov Identifier: NCT02463864
Recruitment Status : Completed
First Posted : June 4, 2015
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Suzanne Timmons, University College Cork

Study Description
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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.

Condition or disease Intervention/treatment Phase
Frail Older Adults Other: Intervention exercise Other: Sham Exercise Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial to Measure the Effects of Twice-Daily Individual, Targeted, Strengthening, Balance and Endurance Exercise Sessions on Mobility, Quality of Life and Healthcare Utilisation for Frail Older Medical In-patients
Actual Study Start Date : March 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention exercise
Twice daily, individual, targeted, strengthening, balance and endurance exercise sessions
 Other: 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.
Other Name: Augmented Prescribed Exercise Program
Sham Comparator: Sham exercise
Twice daily, individual, stretching and relaxation exercise sessions
 Other: Sham Exercise
Twice daily stretching and relaxation exercises for the duration of the hospital stay, by a senior physiotherapist.


Outcome Measures
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Primary Outcome Measures :
  1. Length of Stay [ Time Frame: At time of discharge from hospital (an expected average of 8 days post admission) ]
    Patients length of hospital stay is recorded at the time of discharge from electronic admissions data


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. Quality of Life [ Time Frame: At time of discharge from hospital (an expected average of 8 days post admission); and again at 3 months post discharge ]
    The EQ5D-5L will be completed by the patient.

  3. Re-admission Rate [ Time Frame: From the time of hospital discharge to 3 months post discharge ]
    The number of admissions within 3 months following the index admission will be recorded from hospital electronic records


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02463864


Locations
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Ireland
Mercy University Hospital
Cork, Ireland, 00
Sponsors and Collaborators
University College Cork
Investigators
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Principal Investigator: Suzanne Timmons University College Cork
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr Suzanne Timmons, Senior Lecturer in Gerontology and Rehabilitation, University College Cork
ClinicalTrials.gov Identifier: NCT02463864    
Other Study ID Numbers: UCCork
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Keywords provided by Dr Suzanne Timmons, University College Cork:
frailty
older adult
hospital
 exercise
randomised control trial
functional decline