Frail Older AdultsAPEPNCT02463864
A Twice-Daily Individual Targeted Exercise Program in Frail Hospitalised Older Medical In-patients (RCT)
A study testing Intervention exercise in people with Frail Older Adults, run by University College Cork at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Older Adults
- What is being tested?
- Intervention exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteIreland
- Study dates
- Mar 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- medical patients
- anticipated length of stay greater than 2 days
- planned for discharge home
- mobility aid and /or assistance required on admission
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Frail Older Adults
- Being tested
- Intervention exercise, Sham Exercise
- Keywords
- frailty, older adult, hospital, exercise, randomised control trial, functional decline
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention exerciseOther
Also called Augmented Prescribed Exercise Program
Twice daily, individual, targeted, strengthening, balance and endurance exercises for the duration of the hospital stay, prescribed and delivered by a senior physiotherapist.
Sham ExerciseOther
Twice daily stretching and relaxation exercises for the duration of the hospital stay, by a senior physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Intervention exercise | Experimental | Twice daily, individual, targeted, strengthening, balance and endurance exercise sessions Receives: Other: Intervention exercise |
| Sham exercise | Sham comparator | Twice daily, individual, stretching and relaxation exercise sessions Receives: Other: Sham Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Patients length of hospital stay is recorded at the time of discharge from electronic admissions data
Measured: At time of discharge from hospital (an expected average of 8 days post admission)
Secondary outcomes (3)
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.
Measured: At time of discharge from hospital (an expected average of 8 days post admission); and again at 3 months post discharge
Quality of Life
The EQ5D-5L will be completed by the patient.
Measured: At time of discharge from hospital (an expected average of 8 days post admission); and again at 3 months post discharge
Re-admission Rate
The number of admissions within 3 months following the index admission will be recorded from hospital electronic records
Measured: From the time of hospital discharge to 3 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Frail Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Suzanne Timmons, University College Cork
- Investigators
- Suzanne Timmons, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463864
- Sponsor's protocol ID
- UCCork
- Acronym
- APEP
- Status last verified
- Nov 2017
- First submitted
- 26 May 2015
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32033532McCullagh 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.
PubMed 27059306
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02463864
- Acronym / sponsor ID
- APEP / UCCork
- Conditions
- Frail Older Adults
- Keywords
- frailty, older adult, hospital, exercise, randomised control trial, functional decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention exercise | Experimental | Other: Intervention exerciseTwice daily, individual, targeted, strengthening, balance and endurance exercise sessions |
| Sham exercise | Sham comparator | Other: Sham ExerciseTwice daily, individual, stretching and relaxation exercise sessions |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- medical patients
- anticipated length of stay greater than 2 days
- planned for discharge home
- mobility aid and /or assistance required on admission
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention exerciseAlso: Augmented Prescribed Exercise ProgramTwice daily, individual, targeted, strengthening, balance and endurance exercises for the duration of the hospital stay, prescribed and delivered by a senior physiotherapist. | Other | Intervention exercise |
| Sham ExerciseTwice daily stretching and relaxation exercises for the duration of the hospital stay, by a senior physiotherapist. | Other | Sham exercise |
Primary outcome
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
3 secondary outcomes
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
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
Re-admission Rate
Time frame: From the time of hospital discharge to 3 months post discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: PubMed 32033532McCullagh 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.
- Derived from this study: PubMed 27059306McCullagh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Timmons principal investigator
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention exercise in people with Frail Older Adults, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay (time frame: At time of discharge from hospital (an expected average of 8 days post admission)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02463864, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.