Clinical trial NCT02463864: A Twice-Daily Individual Targeted Exercise Program in Frail Hospitalised Older Medical In-patients (RCT)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Older Adults
Keywords: frailty
older adult
hospital
exercise
randomised control trial
functional decline
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 190
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Length of Stay
timeFrame: At time of discharge from hospital (an expected average of 8 days post admission)
Secondary outcomes:
measure: Physical Performance
timeFrame: At time of discharge from hospital (an expected average of 8 days post admission); and again at 3 months post discharge
measure: Quality of Life
timeFrame: At time of discharge from hospital (an expected average of 8 days post admission); and again at 3 months post discharge
measure: Re-admission Rate
timeFrame: From the time of hospital discharge to 3 months post discharge
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Mercy University Hospital
Study officials:
affiliation: University College Cork
name: Suzanne Timmons
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.