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21 May 2012
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| [ Print-friendly version ] |
| Promoting physical activity in people aged 65+ |
| ISRCTN | ISRCTN43453770 |
| ClinicalTrials.gov identifier | NCT00726531 |
| Public title | Promoting physical activity in people aged 65+ |
| Scientific title | Multi-centre cluster randomised trial comparing a community group exercise programme with home based exercise with usual care for people aged 65 and over in primary care |
| Acronym | ProAct65+ |
| Serial number at source | HTA 06/36/04 |
| Study hypothesis |
1. 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
2. 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) 3. 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. 4. To determine the acceptability of the programmes, adherence rates, enabling factors and barriers to future implementation 5. To determine participants' perceptions of the value of exercise, and the predictors of continued exercise More details can be found at: http://www.hta.ac.uk/1708 Protocol in: http://www.hta.ac.uk/protocols/200600360004.pdf Please note that, as of 21/04/2009, extensive amendments have been made to this trial record based on the finalised protocol. All changes are recorded within the relevant fields except the following: 1. The public title has been changed from "Promoting physical activity in the over 65s" to "Promoting physical activity in people aged 65+" 2. The scientific title has been changed from "Multi-centre cluster randomised trial comparing a community group exercise programme with home based exercise with usual care for over 65s in primary care" to "Multi-centre cluster randomised trial comparing a community group exercise programme with home based exercise with usual care for people aged 65 and over in primary care" |
| Lay summary | |
| Ethics approval | Nottingham Local Research Ethics Committee 2. Date of approval: 23/06/2008 (ref: 08/H0408/72) |
| Study design | Cluster-randomised controlled multi-centre trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Falls risk in people aged 65 years and over |
| Participants - inclusion criteria |
Current inclusion criteria as of 21/04/2009:
1. Those aged 65+ who can walk around independently indoors and outdoors (with or without a walking aid) 2. Physically able to take part in a group exercise class 3. Those who are not already receiving any long term physiotherapy 4. Those who do not fulfil the exclusion criteria Previous inclusion criteria: Eligible patients (both males and females) 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. |
| Participants - exclusion criteria |
Current exclusion criteria as of 21/04/2009:
1. Three or more falls in the previous year ("frequent fallers") 2. Resting BP >180/100 mmHg; tachycardia >100 bpm; those considered by their GP to have uncontrolled hypertension; significant drop in BP during exercise recorded in the medical records or found at initial assessment 3. Psychiatric conditions which would prevent participation in an exercise class, for example, psychotic illness 4. Uncontrolled medical problems, which the GP considers would exclude patients from undertaking the exercise programme; for example, acute systemic illness such as pneumonia, poorly controlled angina, acute rheumatoid arthritis, unstable or acute heart failure 5. Conditions requiring a specialist exercise programme, for example, uncontrolled epilepsy, significant neurological disease or impairment; unable to maintain seated upright position or unable to move about independently indoors 6. Not living independently (e.g., residential or nursing care) 7. Significant cognitive impairment (unable to follow simple instructions) 8. Already receiving long term physiotherapy Previous exclusion criteria: 1. 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 the exercise programme) 2. Resting blood pressure (BP) >180/100 mmHg; tachycardia >100 bpm; those considered by their GP to have uncontrolled hypertension; significant drop in BP during exercise recorded in the medical records or found at initial assessment 3. 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 4. Not living independently (e.g. residential care) 5. Significant cognitive impairment (unable to follow simple instructions) 6. Already receiving long term physiotherapy |
| Anticipated start date | 01/06/2008 |
| Anticipated end date | 31/05/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 1,200 |
| Interventions |
Current interventions as of 21/04/2009:
This is a cluster randomised controlled trial using minimisation for allocation at the level of general practice in two centres (London and Nottingham/Derby). Practice staff will also be advised that they will not be informed of the practice’s study group allocation until after they have given consent to take part in the study, and all eligible patients from the practice have been recruited. Arm 1: Home based exercise programme (OEP) (n = 400) 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, plus participants will be advised to walk at least twice per week for up to 30 minutes at a moderate pace, 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. Arm 2: Community based exercise programme (FaME) (n = 400) FaME consists of one hour long 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 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. Arm 3: 'Treatment as usual' group (n = 400) Total duration of interventions: 24 weeks Total duration of follow-up: 24 months from the end of the intervention Previous interventions: This is a cluster randomised controlled trial using minimisation for allocation at the level of general practice in two centres (London and Nottingham/Derby). 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. Community based exercise programme (FaME): FaME includes and extends the OEP. It will comprise one hour long, postural stability instructor (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. There will also be a 'treatment as usual' group. Total duration of interventions: 24 weeks Total duration of follow-up: 24 months from the end of the intervention |
| Primary outcome measure(s) |
1. Proportions reaching the recommended physical activity (PA) target of at least 30 minutes of activity of moderate intensity on at least 5 days each week, measured using the Community Healthy Activities Model Program for Seniors (CHAMPS), Physical ACtivity in Elderly people (PACE) and Phone_FITT questionnaires. The proportion reaching the recommended target will be compared between treatment groups using random effects logistic regression to estimate odds ratios and 95% confidence intervals (CI).
All primary and secondary outcome measures will be conducted at 6, 12, 18 and 24 months after intervention is completed. Please note that the following primary outcome measure has been removed as of 21/04/2009: 2. Euroqol EQ-5D scores transformed into quality adjusted life years (QALYS) |
| Secondary outcome measure(s) |
Current secondary outcome measures as of 21/04/2009:
1. The direct health benefits i.e. functional and psychological status; the rate of falls and the number and nature of falls, and fear of falling. 2. Stage of change, self efficacy for exercise and physical self-perception (self-esteem relative to the physical domain), which includes measurement of perceived importance (the degree to which participants value their physical condition, body image and physical strength) to inform predictors of exercise adherence and continuation, and participants’ judgement of the value or importance of physical activity. 3. Quality adjusted life years (QALYS), using SF-12® Health Survey scores transformed into EQ-5D utility weights. 4. The direct costs of delivering both exercise programmes, and the cost offsets identified from a comparison of the health and social service utilisation of participants in all groups during the study period. All primary and secondary outcome measures will be conducted at 6, 12, 18 and 24 months after intervention is completed. Previous secondary outcome measures: 1. The direct costs of delivering both exercise programmes, and the health and social service utilisation of participants during the study period 2. The direct health benefits i.e. functional and psychological status; the rate of falls and the number and nature of falls, and fear of falling 3. Stage of change, self efficacy for exercise and physical self-perception (self-esteem relative to the physical domain), which includes measurement of perceived importance (the degree to which participants value their physical condition, body image and physical strength) to inform predictors of exercise adherence and continuation, and participants' judgement of the value or importance of physical activity All primary and secondary outcome measures will be conducted at 6, 12, 18 and 24 months after intervention is completed. |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications | 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20082696 |
| Contact name | Prof Steve Iliffe |
| Address |
Department of Primary Care & Population Health
University College London Rowland Hill Street |
| City/town | London |
| Zip/Postcode | NW3 2PF |
| Country | United Kingdom |
| s.iliffe@pcps.ucl.ac.uk | |
| Sponsor | University College London (UK) |
| Address |
Research Office
Gower Street |
| City/town | London |
| Zip/Postcode | WC1E 6BT |
| Country | United Kingdom |
| Sponsor website: | http://www.ucl.ac.uk |
| Date applied | 11/08/2008 |
| Last edited | 26/01/2010 |
| Date ISRCTN assigned | 12/08/2008 |
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