'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
Protocol serial number 7886
Sponsor Bradford Institute for Health Research (UK)
Funder Dunhill Medical Trust (UK)
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

Institute for Health Research
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Study information

Primary study designInterventional
Study designSingle centre randomised interventional treatment and prevention trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleImproving the functional status of community dwelling, frail older people: the impact of a targeted exercise programme
Study acronymHOPE
Study objectivesOur 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) studiedTopic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Age and ageing
InterventionOur 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 typeOther
Primary outcome measure(s)

Timed Up and Go test at 12 weeks post-randomisation

Key secondary outcome measure(s)

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

Completion date30/09/2011

Eligibility

Participant type(s)Patient
Age groupOther
SexAll
Target sample size at registration100
Key inclusion criteriaCurrent 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 criteriaCurrent 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 enrolment01/04/2010
Date of final enrolment30/09/2011

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Institute for Health Research
Bradford
BD9 6RJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2014 Yes No
Protocol article protocol 08/06/2011 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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