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

November 14, 2017 updated by: Dr Suzanne Timmons, University College Cork

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Cork, Ireland, 00
        • Mercy University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At time of discharge from hospital (an expected average of 8 days post admission)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At time of discharge from hospital (an expected average of 8 days post admission); and again at 3 months post discharge
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.
At time of discharge from hospital (an expected average of 8 days post admission); and again at 3 months post discharge
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
From the time of hospital discharge to 3 months post discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Cork

Investigators

  • Principal Investigator: Suzanne Timmons, University College Cork

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

June 2, 2015

First Posted (Estimate)

June 4, 2015

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 14, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UCCork

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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