Condition category
Signs and Symptoms
Date applied
19/05/2010
Date assigned
19/05/2010
Last edited
22/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Paul Clegg

ORCID ID

Contact details

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

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 measures

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

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

http://www.bradfordresearch.nhs.uk/

Funders

Funder type

Charity

Funder name

Dunhill Medical Trust (UK)

Alternative name(s)

DMT

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21651805
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24742587

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes