Condition category
Injury, Occupational Diseases, Poisoning
Date applied
03/04/2017
Date assigned
19/04/2017
Last edited
19/04/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Frailty is common condition in older adults. As people age, their bodies change and they can lose their inbuilt reserves. These changes mean that older people with frailty can become less mobile and unable to carry out day-to-day tasks when they have a minor illness, such as an infection, or an injury, such as a fracture. Older people with frailty are therefore likely to need a period of rehabilitation to improve overall muscle strength and function before returning home from hospital. Current NHS practice is for a relatively short rehabilitation period and research suggests any initial improvement during this period of rehabilitation may not be sustained. This study is looking at a new exercise programme called developed the Home-based Older People's Exercise (HOPE) programme, which involves a 24-week programme of exercises delivered via a manual under the guidance of a trained therapist. The aim of this study is to find out if the HOPE programme can improve quality of life for older people with frailty who have been discharged home from hospital or from intermediate care (community-based rehabilitation services) after illness or injury.

Who can participate?
Frail older adults who have been admitted to hospital following a sudden illness or injury.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive usual care only, which may differ according to individual needs and the hospital they have been admitted to. Those in the second group receive usual care with the addition of the HOPE programme. This involves taking part in a 12 week exercise programme exercises delivered via a manual under the guidance of a trained therapist, followed by 12 weeks of telephone-based support. At the start of the study and then after six and 12 months, participants in both groups complete a range of questionnaires in order to assess their functional abikity and quality of life.

What are the possible benefits and risks of participating?
Patients who take part in the exercise programme may benefit through an improvement in their functional abilities at home. This could lead to greater independence in the home environment and stabilise their frailty, potentially leading to a reduction in hospital admission and allowing them to continue living at home for as long as possible. It is not anticipated that the exercise programme will cause significant pain, distress or inconvenience. However it is possible that exercises may result in minor discomfort, such as sore muscles. It is also possible that increased functional and walking ability could increase the risk of falls due to increased mobilisation, however therapists will work to increase muscle strength, and with practice may reduce risk of falls.

Where is the study run from?
Bradford Royal Infirmary and at least nine other NHS hospitals in Yorkshire and the South West of England (UK)

When is the study starting and how long is it expected to run for?
March 2017 to March 2021

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mrs Amanda Lilley-Kelly
a.c.lilley-kelly@leeds.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Amanda Lilley-Kelly

ORCID ID

Contact details

Leeds Institute of Clinical Trials Research (LICTR)
Clinical Trials Research Unit
University of Leeds
Leeds
LS2 9JT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

34138

Study information

Scientific title

Individually randomised controlled multi-centre trial to determine the clinical and cost effectiveness of a home-based exercise intervention for older people with frailty as extended rehabilitation following acute illness or injury, including embedded process evaluation

Acronym

HERO

Study hypothesis

The aim of this study is to determine the clinical and cost effectiveness of a home-based exercise intervention for older people with frailty as extended rehabilitation following acute illness or injury.

Ethics approval

ref: 17/YH/0097

Study design

Randomised; Interventional; Design type: Treatment, Complex Intervention, Physical, Rehabilitation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Ageing, Primary sub-specialty: Ageing; UKCRC code/ Disease: Injuries and Accidents/ Injuries to unspecified part of trunk, limb or body region

Intervention

Participants will be individually randomised using an automated 24 hour randomisation service on a 1.25:1 allocation ratio to either HOPE extended rehabilitation programme plus Usual Care, or Usual Care only. The randomisation service will use a computer generated minimisation programme incorporating a random element and stratification factors.

Intervention group: Participants receive the HOPE Extended Rehabilitation programme plus usual care. The HOPE programme is a 24-week home-based manualised, graded, progressive exercise intervention aimed at improving strength, endurance and balance, delivered by community therapy staff. The manual consists of five sections:
1. Information
2. Safety tips
3. Good posture
4. Exercises
5. Staying on track.
Following the 12-week programme participants will receive a further 12 weeks of telephone-based support for intervention sustainability. The core constituents of the HOPE programme are strengthening exercises for the muscle groups required for basic mobility skills like getting out of bed, standing up from a chair, walking a short distance and getting off the toilet. The exercises require no special equipment and can be performed without professional supervision. At the beginning of the intervention participants are requested to perform five repetitions of each exercise in the routine. This progresses to 10 and then 15 repetitions as performance improves. The exercise routine takes less than 15 minutes to complete, and participants are requested to complete the routine 3 times a day on 5 days of the week. Progression is by increasing repetitions, introducing new exercises or advancing to the next HOPE programme level. In accordance with the pragmatic study design, and to best reflect clinical practice, the study protocol does not restrict access/referral to usual care services. Additional interventions during study participation will be documented as part of the usual care review.

Control group: Participants receive usual care only. Usual care is defined as ‘The wide range of care that is provided in a community whether it is adequate or not, without a normative judgment’. Usual care will be provided by primary care, secondary care, community and social services and will be available to both intervention and control participants.

Participants in both groups are followed up after 6 and 12 months. Assessments can be completed by post, telephone, and face-to-face dependent upon the participant’s needs. CTRU will co-ordinate follow-up assessments, confirming survival status and address, and determining the appropriate method of contact. Participants that require telephone or face-to-face contact will be highlighted to the recruiting team (CRN/local Research) to ensure continuity of care. Follow-up assessments will be completed by a blinded Researcher (where relevant), with the method of collection and Researchers completing information (where applicable) documented on data collection forms.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Physical Component Summary (PCS) derived from the Short Form 36 item health questionnaire (SF36) at baseline, 6 and 12 months.

Secondary outcome measures

1. Activities of daily living using the Barthel Index of activities of daily living and the Nottingham Extended Activities of Daily Living (NEADL) at baseline, 6 and 12 months
2. Quality of Life assessed using the EuroQol 5-Dimension Health Questionnaire (EQ-5D-5L) at baseline, 6 and 12 months
3. Healthcare Resource (i.e. hospital visits, GP appointments) assessed using the Healthcare Resource Use at baseline, 6 and 12 months
4. Mental Health assessed using the SF36 Mental Component Summary (MCS) at baseline, 6 and 12 months
5. Cost effectiveness assessed using the Short-Form health survey 6 dimension score (SF6D) at baseline, 6 and 12 months
6. Intervention delivery data (adherence) will be collected from HOPE trained therapists in the form of a Therapy Record completed weekly over 24 weeks per participant
7. Exercise is assesed using a weekly exercise diary kept during the course of intervention delivery (24 weeks)

Overall trial start date

01/03/2017

Overall trial end date

31/03/2021

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 65 years and over
2. Admitted to elderly medicine / trauma & orthopaedics wards following acute illness or injury then discharged home from hospital or from intermediate care
3. Frailty, identified using a score of 5-7 on the 9-item Clinical Frailty Scale (CFS)
4. Mobility, identified by ability to complete the TUGT without additional external support (other than usual walking aids)
5. Willing and able to give informed consent to participate in the study or consultee declaration where the patient lacks capacity
6. Able to communicate by telephone (to support intervention delivery, and follow-up assessments - dependent upon allocation and method of completion)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 718; UK Sample Size: 718

Participant exclusion criteria

1. Permanent care home residents (but not those occupying temporary rehabilitation beds within a care home as part of intermediate care services)
2. Moderate/severe dementia at baseline* (defined as Montreal Cognitive Assessment test < 20)
3. Severe, disabling stroke at baseline* (defined as new or previous stroke with Barthel Index < 9)
4. Recent (< 3 months prior randomisation) myocardial infarction, or unstable angina
5. Another household member in the study
6. Very severe frailty (defined as score of 8 on CFS)
7. Terminally ill (defined as score of 9 on CFS)
8. Receiving palliative care
9. Referral at discharge for condition-specific rehabilitation (e.g. pulmonary rehabilitation, stroke rehabilitation)
10. Currently participating in HERO or another contraindicated study

Recruitment start date

01/12/2017

Recruitment end date

01/11/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

St James’ University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Trial participating centre

Royal Devon and Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom

Trial participating centre

Torbay Hospital
Newton Road
Torquay
TQ2 7AA
United Kingdom

Trial participating centre

Harrogate District Hospital
Lancaster Park Road
Harrogate
HG2 7SX
United Kingdom

Trial participating centre

Mid Yorkshire Hospital
Rowan House Aberford Road
Wakefield
WF1 4EE
United Kingdom

Sponsor information

Organisation

Bradford Teaching Hospitals NHS Foundation Trust

Sponsor details

Research Management & Support Office
Bradford Institute for Health Research
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

A dissemination strategy will be developed by the Trial Management Group (TMG) in collaboration with PPI representatives working on the project. It is intended that this will include publication of main trial findings in a high-impact peer reviewed journal following completion of analysis around May 2021.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/05/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes