'The Home-based Older People's Exercise (HOPE) Programme: An Exercise Programme to Improve the Functional Status of Older People
| ISRCTN | ISRCTN57066881 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57066881 |
| Secondary identifying numbers | 7886 |
- Submission date
- 19/05/2010
- Registration date
- 19/05/2010
- Last edited
- 22/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andrew Paul Clegg
Scientific
Scientific
Institute for Health Research
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Study information
| Study design | Single centre randomised interventional treatment and prevention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Improving the functional status of community dwelling, frail older people: the impact of a targeted exercise programme |
| Study acronym | HOPE |
| Study objectives | 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(s) | Bradford Research Ethics Committee approved on the 23rd June 2009 (ref: 09/H1302/55). Amendment approved on 01/10/2010. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2010 |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | Planned sample size: 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2010 |
| Date of final enrolment | 30/09/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute for Health Research
Bradford
BD9 6RJ
United Kingdom
BD9 6RJ
United Kingdom
Sponsor information
Bradford Institute for Health Research (UK)
Research organisation
Research organisation
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
| Website | http://www.bradfordresearch.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/05gekvn04 |
Funders
Funder type
Charity
Dunhill Medical Trust (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Dunhill Medical Trust, DMT
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 08/06/2011 | Yes | No | |
| Results article | results | 01/09/2014 | Yes | No |
