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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: February 2017

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Intervention exercise
    • Twice daily, individual, targeted, strengthening, balance and endurance exercise sessions
  • Sham Comparator: Sham exercise
    • Twice daily, individual, stretching and relaxation exercise sessions

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University College Cork
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr Suzanne Timmons, Senior Lecturer in Gerontology and Rehabilitation – University College Cork
  • Overall Official(s)
    • Suzanne Timmons, Principal Investigator, University College Cork

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