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

Frail Older Adults Clinical Trial

— APEP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02463864
• Other study ID #: UCCork
• Status: Completed
• Phase: N/A
• First received: May 26, 2015
• Last updated: November 14, 2017
• Start date: March 2015
• Est. completion date: May 2017

Study information

• Verified date: November 2017
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: May 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frail Older Adults

Intervention

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

Locations

Country	Name	City	State
Ireland	Mercy University Hospital	Cork

Sponsors (1)

Lead Sponsor	Collaborator
University College Cork

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Stay	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	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.	At time of discharge from hospital (an expected average of 8 days post admission); and again at 3 months post discharge
Secondary	Quality of Life	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
Secondary	Re-admission Rate	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