FallsPhase 3ProAct65+NCT00726531
Promoting Physical Activity in the Over 65s
A Phase 3 study testing Otago Exercise Programme, Fame and Treatment As Usual in people with Falls, run by University College, London at 2 sites in United Kingdom.
Trial summary
The aim of the project is to evaluate the delivery, impact and cost effectiveness of a community based exercise programme (FaME); compared to a home based exercise programme (OEP) supported by similarly aged mentors; compared with usual care for primary care patients. Primary Objective: 1. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Falls
- What is being tested?
- Otago Exercise Programme, Fame and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jun 2008to May 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Eligible patients will be those aged 65+ who can walk around at home (i.e. not chair or bed bound) and would be physically able to take part in a group exercise class, who are not already receiving any long term physiotherapy and who do not fulfill the exclusion criteria.
Who cannot join
- Chair or bed bound
- Receiving long-term physiotherapy
- Three or more falls in the previous year i.e. frequent fallers (only excluded if their GP does not consent to them taking part in exercise)
- Resting BP > 180/100 mmHg, tachycardia > 100bpm, uncontrolled hypertension
- Significant drop in BP during exercise
- Psychiatric conditions or physical abilities which would prevent participation in an exercise class (for example psychotic illness, acute systemic illness (e.g. pneumonia), uncontrolled visual or vestibular disturbances which the GP considers would exclude patients from undertaking the exercise programme, poorly controlled angina, acute rheumatoid arthritis, unstable or acute heart failure, or conditions requiring a specialist exercise programme e.g. uncontrolled epilepsy significant neurological disease or impairment, unable to maintain seated upright position or unable to move about independently indoors)
- Not living independently (e.g. residential care)
- Significant cognitive impairment (unable to follow simple instructions)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
University College London
London
Steve Iliffe
- Recruiting
University of Nottingham
Nottingham
Denise Kendrick
About this study
Official title: Multi-centre Cluster Randomised Trial Comparing a Community Group Exercise Programme With Home Based Exercise With Usual Care for Over 65s in Primary Care
The aim of the project is to evaluate the delivery, impact and cost effectiveness of a community based exercise programme (FaME); compared to a home based exercise programme (OEP) supported by similarly aged mentors; compared with usual care for primary care patients.
Primary Objective:
- To determine the effect on continuation of exercise of two evidence based exercise programmes designed for older people, compared with usual care i.e. with no special interventions to promote physical activity. Secondary Objective:
- To determine the health benefits of the programmes to patients starting at various levels of physical activity, particularly the effects on physical and psychological status, health status and quality adjusted life years (QALYs).
- To estimate the costs of the exercise interventions and to assess the cost-effectiveness of community group exercise, and home-supported exercise compared with usual care.
- To determine the acceptability of the programmes, adherence rates, enabling factors and barriers to future implementation.
- To determine participants' perceptions of the value of exercise, and the predictors of continued exercise.
Read the detailed description
A cluster controlled trial using minimisation for allocation at the level of general practice in two centres (London and Nottingham/Derby), to compare a community-centre based group exercise programme - FaME [delivered by specifically trained postural stability instructors (PSIs) and supplemented by home exercise and prescriptive recommendations for walking], with a home based exercise programme and walking plan - OEP [supported by specifically trained and similarly aged mentors], with two years follow-up to determine the impact, acceptability and adherence to the programme, and longer term continuation of exercise. Control subjects will continue to receive usual care in primary care. A cost-effectiveness analysis will be conducted within the study.
- Conditions
- Falls
- Being tested
- Otago Exercise Programme, Fame, Treatment As Usual
- Keywords
- Falls prevention, Exercise promotion, Older people
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago Exercise ProgrammeBehavioural
Home based exercise programme (OEP) This exercise programme consists of a 30 minute programme of leg muscle strengthening and balance retraining exercises progressing in difficulty to be performed at home at least three times per week, and a walking plan to be undertaken at least two times per week for 24 weeks. . Trained peer mentors will contact and visit the patients at their home to start the exercise programme with them and will follow-up with up to three more home visits / exercise sessions as the participants require
FameBehavioural
Community based exercise programme (FaME) FaME includes and extends the OEP. It will comprise one hour PSI delivered group exercise class in a local community centre for a maximum of 15 participants, and two 30 minute home exercise sessions (based on the extended OEP) per week for 24 weeks. Participants will also be advised to walk at least twice per week for up to 30 minutes at a moderate pace.
Treatment As UsualOther
Also called Usual clinical care
Treatment as usual by the general practitioner
| Study group | Role | What they receive |
|---|---|---|
| OEP | Experimental | Home based exercise programme (OEP) This exercise programme consists of a 30 minute programme of leg muscle strengthening and balance retraining exercises progressing in difficulty to be performed at home at least three times per week, and a walking plan to be undertaken at least two times per week for 24 weeks. . Trained peer mentors will contact and visit the patients at their home to start the exercise programme with them and will follow-up with up to three more home visits / exercise sessions as the participants require Receives: Behavioral: Otago Exercise Programme |
| Fame | Experimental | Community based exercise programme (FaME) FaME includes and extends the OEP. It will comprise one hour PSI delivered group exercise class in a local community centre for a maximum of 15 participants, and two 30 minute home exercise sessions (based on the extended OEP) per week for 24 weeks. Participants will also be advised to walk at least twice per week for up to 30 minutes at a moderate pace. Receives: Behavioral: Fame |
| TAU | No intervention | Treatment as usual Receives: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
type, intensity, duration and frequency of physical activity
Measured: two years after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionMay 2011 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallsStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham
- Investigators
- Denise Kendrick, PhD, Study director, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726531
- Sponsor's protocol ID
- ProAct65+
- Other IDs
- UK HTA grant 06/36/04
- Acronym
- ProAct65+
- Status last verified
- Jul 2010
- First submitted
- 29 Jul 2008
- Last updated
- 8 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre Cluster Randomised Trial Comparing a Community Group Exercise Programme With Home Based Exercise With Usual Care for Over 65s in Primary Care
- ClinicalTrials.gov ID
- NCT00726531
- Acronym / sponsor ID
- ProAct65+ / ProAct65+
- Conditions
- Falls
- Keywords
- Falls prevention, Exercise promotion, Older people
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University of Nottingham
- Study start
- Jun 2008
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 1 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the project is to evaluate the delivery, impact and cost effectiveness of a community based exercise programme (FaME); compared to a home based exercise programme (OEP) supported by similarly aged mentors; compared with usual care for primary care patients.
Primary Objective:
- To determine the effect on continuation of exercise of two evidence based exercise programmes designed for older people, compared with usual care i.e. with no special interventions to promote physical activity. Secondary Objective:
- To determine the health benefits of the programmes to patients starting at various levels of physical activity, particularly the effects on physical and psychological status, health status and quality adjusted life years (QALYs).
- To estimate the costs of the exercise interventions and to assess the cost-effectiveness of community group exercise, and home-supported exercise compared with usual care.
- To determine the acceptability of the programmes, adherence rates, enabling factors and barriers to future implementation.
- To determine participants' perceptions of the value of exercise, and the predictors of continued exercise.
Detailed description
A cluster controlled trial using minimisation for allocation at the level of general practice in two centres (London and Nottingham/Derby), to compare a community-centre based group exercise programme - FaME [delivered by specifically trained postural stability instructors (PSIs) and supplemented by home exercise and prescriptive recommendations for walking], with a home based exercise programme and walking plan - OEP [supported by specifically trained and similarly aged mentors], with two years follow-up to determine the impact, acceptability and adherence to the programme, and longer term continuation of exercise. Control subjects will continue to receive usual care in primary care. A cost-effectiveness analysis will be conducted within the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OEP | Experimental | Behavioral: Otago Exercise ProgrammeHome based exercise programme (OEP) This exercise programme consists of a 30 minute programme of leg muscle strengthening and balance retraining exercises progressing in difficulty to be performed at home at least three times per week, and a walking plan to be undertaken at least two times per week for 24 weeks. . Trained peer mentors will contact and visit the patients at their home to start the exercise programme with them and will follow-up with up to three more home visits / exercise sessions as the participants require |
| Fame | Experimental | Behavioral: FameCommunity based exercise programme (FaME) FaME includes and extends the OEP. It will comprise one hour PSI delivered group exercise class in a local community centre for a maximum of 15 participants, and two 30 minute home exercise sessions (based on the extended OEP) per week for 24 weeks. Participants will also be advised to walk at least twice per week for up to 30 minutes at a moderate pace. |
| TAU | No intervention | Other: Treatment As UsualTreatment as usual |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Eligible patients will be those aged 65+ who can walk around at home (i.e. not chair or bed bound) and would be physically able to take part in a group exercise class, who are not already receiving any long term physiotherapy and who do not fulfill the exclusion criteria.
Key exclusion criteria (8 listed)
- Chair or bed bound
- Receiving long-term physiotherapy
- Three or more falls in the previous year i.e. frequent fallers (only excluded if their GP does not consent to them taking part in exercise)
- Resting BP > 180/100 mmHg, tachycardia > 100bpm, uncontrolled hypertension
- Significant drop in BP during exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Otago Exercise ProgrammeHome based exercise programme (OEP) This exercise programme consists of a 30 minute programme of leg muscle strengthening and balance retraining exercises progressing in difficulty to be performed at home at least three times per week, and a walking plan to be undertaken at least two times per week for 24 weeks. . Trained peer mentors will contact and visit the patients at their home to start the exercise programme with them and will follow-up with up to three more home visits / exercise sessions as the participants require | Behavioural | OEP |
| FameCommunity based exercise programme (FaME) FaME includes and extends the OEP. It will comprise one hour PSI delivered group exercise class in a local community centre for a maximum of 15 participants, and two 30 minute home exercise sessions (based on the extended OEP) per week for 24 weeks. Participants will also be advised to walk at least twice per week for up to 30 minutes at a moderate pace. | Behavioural | Fame |
| Treatment As UsualAlso: Usual clinical careTreatment as usual by the general practitioner | Other | TAU |
Primary outcome
type, intensity, duration and frequency of physical activity
Time frame: two years after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Kendrick, PhD study director
University of Nottingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Otago Exercise Programme, Fame and Treatment As Usual in people with Falls, run by University College, London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steve Iliffe, MB BS, BSc (00442078302393, s.iliffe@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
type, intensity, duration and frequency of physical activity (time frame: two years after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2010.