Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7886
Study information
Scientific title
Improving the functional status of community dwelling, frail older people: the impact of a targeted exercise programme
Acronym
HOPE
Study hypothesis
Our exploratory randomised controlled trial is to investigate whether the HOPE Programme, a 12 week exercise programme designed for frail older people living at home, can improve functional status, daily living activities and quality of life. Participants will be stratified by baseline Timed Up and Go test and will undergo concealed random allocation to the HOPE Programme or usual care. The HOPE Programme, developed and refined by multiperspective qualitative methods involving our user group and experienced healthcare professionals, will be delivered by community based therapists to older people under the care of a case manager (e.g. Community Matron) or older people who are housebound, defined as being unable to leave the house without the assistance of another person, in Bradford, UK.
Primary outcome will be the Timed Up and Go test. Secondary outcomes will include Barthel Index of Activities of Daily Living, quality of life measures and self-reported falls. We will also record participant comorbidity and operationalised measures of frailty.
As of 23/02/2011 this record has been updated, in response to a protocol amendment which was approved on 01/10/2010 by the Bradford REC. All changes can be found under the relevant section with the protocol update date of 01/10/2010.
Ethics approval
Bradford Research Ethics Committee approved on the 23rd June 2009 (ref: 09/H1302/55). Amendment approved on 01/10/2010.
Study design
Single centre randomised interventional treatment and prevention trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Age and ageing
Intervention
Our exploratory randomised controlled trial is to investigate whether the HOPE Programme, a 12 week manualised exercise programme designed for frail older people living at home, can improve functional status, daily living activities and quality of life. Participants will be older people under the care of a case manager (e.g. Community Matron) or older people who are housebound, defined as being unable to leave the house without the assistance of another person, in Bradford, UK. Participants will be stratified by baseline Timed Up and Go Test (TUGT) and will undergo concealed random allocation to the intervention or control group. The intervention group will receive a copy of the HOPE Programme Exercise Manual and will also receive regular home visits from community-based therapists who will both teach the HOPE Programme to participants and provide support with compliance. Support will also be provided by regular telephone contact from therapists. Participants who are randomised to the control group will receive usual care from the case manager and GP.
Primary outcome will be the TUGT. Secondary outcomes will include Barthel Index of Activities of Daily Living, quality of life measures and self-reported falls. All outcomes will be measured at baseline and at 12 weeks post randomisation. We will also record participant comorbidity and operationalised measures of frailty.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Timed Up and Go test at 12 weeks post-randomisation
Secondary outcome measures
1. Barthel Index of Activities of Daily Living, measured at baseline and at 12 weeks post-randomisation
2. EQ5D measure of health, measured at baseline and at 12 weeks post-randomisation
3. Edmonton Frail Scale, measured at baseline and at 12 weeks post-randomisation
4.Geriatric Depression Score, measured at baseline and at 12 weeks post-randomisation
Overall trial start date
01/04/2010
Overall trial end date
30/09/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current protocol (amendment approved 01/10/2010):
1. All patients who are under the care of a case manager (CM) in Bradford, UK. There are currently 21 CMs in Bradford, each with a caseload of approximately 50 patients
2. Older people who are housebound, defined as being unable to leave the house without the assistance of another person
3. Male and female, no age limits
Initial information at time of registration:
1. All patients who are under the care of a case manager (CM) in Bradford, UK. There are currently 21 CMs in Bradford, each with a caseload of approximately 50 patients.
2. Male and female, no age limits
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Planned sample size: 100
Participant exclusion criteria
Current protocol (amendment approved 01/10/2010):
1. Severe dementia
2. Poorly controlled angina
3. Current participation in an alternative exercise programme (e.g. falls prevention programme, pulmonary rehabilitation)
4. Unable to stand from a chair and walk without the assistance of another person
5. Registered blind
6. Receiving palliative care
Initial information at time of registration:
1. Severe dementia
2. Poorly controlled angina
3. Current participation in an alternative exercise programme (e.g. falls prevention programme, pulmonary rehabilitation)
4. Unable to stand from a chair and walk without the assistance of another person
5. Registered blind
Recruitment start date
01/04/2010
Recruitment end date
30/09/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute for Health Research
Bradford
BD9 6RJ
United Kingdom
Sponsor information
Organisation
Bradford Institute for Health Research (UK)
Sponsor details
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
Dunhill Medical Trust (UK)
Alternative name(s)
DMT
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21651805
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24742587
Publication citations
-
Protocol
Clegg A, Barber S, Young J, Forster A, Iliffe S, The Home-Based Older People's Exercise (HOPE) trial: study protocol for a randomised controlled trial., Trials, 2011, 12, 143, doi: 10.1186/1745-6215-12-143.
-
Results
Clegg A, Barber S, Young J, Iliffe S, Forster A, The Home-based Older People's Exercise (HOPE) trial: a pilot randomised controlled trial of a home-based exercise intervention for older people with frailty., Age Ageing, 2014, 43, 5, 687-695, doi: 10.1093/ageing/afu033.