Condition category
Not Applicable
Date applied
29/02/2012
Date assigned
02/03/2012
Last edited
04/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Physical activity is vital for health, yet most adults are inactive and do not achieve the recommended 30 minutes of moderate intensity activity on 5 or more days per week. Adults' most common physical activity is walking, light intensity if strolling, moderate intensity if brisker. Pedometers measure step-count and have been shown to increase walking. However, most pedometer trials have had short-term outcomes, they have not separated out pedometer effects from other support and they have reported only step-counts, not time spent at different physical activity intensities. The aim of this trial is to investigate whether 993 inactive patients aged 45-74 years from 6 London general practices can increase their physical activity as a result of being given a pedometer with a diary and written guidelines, and whether additional tailored support from a practice nurse increases any benefits.

Who can participate?
To take part you need to be aged 45-74 years, registered with one of the six general practices in South West London taking part in the trial, and doing less physical activity than recommended by UK guidelines, i.e. usually doing less than half an hour of moderate or vigorous activity (such as walking or a sport) on five or more days of the week.

What does the study involve?
If you are invited to take part you will be invited to meet with one of the researchers at your GP practice. This meeting will take about 30-45 minutes. You will be asked to :
1. Sign a consent form and fill in a questionnaire about your health.
2. Have your height, weight and waist circumference measured.
3. Record your physical activity in a diary for a week.
4. Wear a belt with two small monitors on, an accelerometer and a pedometer, during the day for a week (the monitors will accurately record your physical activity levels, but will be sealed for the baseline measurements, so they will not give any direct feedback).
5. Return the belt and monitors to the practice when you have finished wearing them.
Participants will be divided into three groups. The groups will be decided randomly, like tossing a coin.
The first group will carry on with their usual activity (the ‘usual physical activity group’). If you are in this group you will be contacted by post 3 months after your first visit and asked to wear the accelerometer again for 7 days. You will be asked to visit the practice 12 months after your first visit and to monitor your activity with the accelerometer for 7 days before that visit. You will be offered a pedometer and guidance on a 12-week walking programme at the end of the study.
The second group will be sent a pedometer, a physical activity diary and instructions for a 12-week walking programme through the post (‘pedometer by post group’). If you are in this group you will be contacted by the researcher one week after you receive the pedometer to check it is working and that you understand the instructions and then you will be contacted at 3 months and 12 months, exactly as for the usual physical activity group.
The third group will meet with the practice nurse and will receive their pedometer, physical activity diary and 12-week walking programme instructions from her (the ‘pedometer plus nurse support group’). If you are in this group you will be invited to see the nurse three times over three months, and each visit will last around 20-30 minutes. The nurse will encourage you to make a physical activity plan and will encourage you to monitor your activity, set goals, overcome barriers to change and increase your confidence to become more active. You will also be contacted by the researcher at 3 months and 12 months, exactly as for the other groups.

What are the possible benefits and risks of participating?
There are many proven benefits from walking more and becoming more active. You will be offered feedback on your individual activity levels and a pedometer to keep at the end of the study and a physical activity consultation with the nurse, if you would like one. This is a very low risk study. If you are in the pedometer by post group or the pedometer plus nurse support group you will be advised to gradually increase your walking in a safe way. However, there is a small risk that you could fall or get pain from unaccustomed walking or you could make a condition that you already have, like arthritis, worse. If you develop new symptoms you should report these to your GP.

Where is the study run from?
It is being organised by St George's University of London. Six general practices in South West London will be recruited, patients will see the researcher and nurse at their own practice.

When is the study starting and how long is it expected to run for?
October 2012 to September 2014.

Who is funding the study?
The study is being funded by the Health Technology Assessment programme of the National Institute of Health Research.

Who is the main contact?
Dr Tess Harris
tharris@sgul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tess Harris

ORCID ID

Contact details

Division of Population Health Sciences & Education
St George's University of London
Cranmer Terrace
Tooting
London
SW17 0RE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 10/32/02

Study information

Scientific title

Randomised controlled trial of a pedometer-based walking intervention with and without practice nurse support in primary care patients aged 45-74 years

Acronym

PACE-UP

Study hypothesis

Does the provision of pedometers with physical activity diaries and written guidelines increase physical activity (average daily step-counts) over the short term (3 months) and longer term (12 months) in inactive primary care patients aged 45-74 years and does additional, individual, tailored support from a practice nurse increase any benefits?

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/103202
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0007/55375/PRO-10-32-02.pdf

Ethics approval

NRES Committee London- Hampstead, ref: 12/LO/0219: approval pending

Study design

Three-arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Inactive primary care patients

Intervention

Nature of the complex intervention: 12 week pedometer-based walking intervention delivered either by post with written instructions or delivered in the context of three brief physical activity consultations with a practice nurse, based on a cognitive behavioural approach.

There are 3 groups: control (usual physical activity); pedometer by post group; pedometer plus nurse support group.

Components of the complex intervention
1. Pedometers
Yamax Digi-Walker SW-200 (Tokyo, Japan) is the criterion pedometer with best accuracy. It provides direct step-count feedback to participants. Step-counts need daily manual recording and re-setting. The pedometer will be delivered by post along with written instructions on its use to the pedometer group, it will be given by the nurse directly to patients in the pedometer plus support group.

2. Written instructions and physical activity diaries for a 12-week pedometer based walking intervention (delivered by post to pedometer group, provided in consultations for pedometer plus nurse support group)

We will have participants baseline step-count from their blinded pedometer assessment. They will be given feedback on this and information about the fact that adding in 3000 steps/day in 30 minutes on five or more days weekly to their baseline would help them to achieve the recommended daily physical activity guidelines and that this can be built up gradually. They will be given advice on the benefits of at least moderate intensity physical activity for health and informed that moderate intensity PA makes you feel warm and makes you feel a bit breathless and increases your heart rate, but that you should still be able to talk. A suggested walking plan will be provided as follows:
Weeks 1-2: Add in 1500 steps in 15 minutes 3 or more days per week
Weeks 3-4: Add in 1500 steps in 15 minutes 5 or more days per week
Weeks 5-6: Add in 3000 steps in 30 minutes (or 2 x 15 minute bouts) on 3 or more days per week
Weeks 7-8: Add in 3000 steps in 30 minutes (or 2 x 15 minute bouts) on 5 or more days per week
Weeks 9-12: Maintenance, continue adding on 3000 steps in 30 minutes on 5 or more days per week.
They will be given diaries for recording their daily step-count on so that they can see if they are acheiving their target for that week. They will be given written advice on how to maintain their activity, and how to anticipate and manage setbacks.

3. Physical activity consultations with a practice nurse based on a cognitive behavioural approach. The cognitive behavioural model includes patient-led goal setting based on behaviour change principles, including motivational language, problem-solving, self-monitoring, SMART goals, social support, relapse prevention, addressing barriers, use of written tools including diaries. These techniques have been successfully used by non-specialists in primary care after brief training and are emphasized in the NHS Health Trainer Handbook. Pedometer measurement and diary recording of step-counts provides clear material for physical activity goal-setting, self-monitoring and feedback and should fit very well with this approach. Practice nurse training in a cognitive behavioural approach to increasing PA based on the NHS Health Trainer handbook, combined with training in advising on a 12-week pedometer based walking intervention will be provided.

1. David L. Using CBT in General Practice. The 10 minute consultation. Oxfordshire: Scion; 2006.
2. British Psychological Society. Improving Health, Changing Behaviour: NHS Health Trainer Handbook. 2008.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Change in average daily step-count, measured over 7 days, between baseline and 12 months assessed objectively by accelerometry (Actigraph GT3X+ Manufacturing Technology Inc, Fl USA)

Secondary outcome measures

1. Change in time spent in:
1.1. At least moderate intensity physical activity and
1.2. Sedentary physical activity between baseline and 12 months, measured over 7 days by accelerometry
2. Change in average daily step-count, time spent in at least moderate physical activity and time spent sedentary measured over 7 days, between baseline and 3 months assessed objectively by accelerometry
3. Cost-effectiveness, incremental cost of the intervention to the NHS and incremental cost per change in step-count and per quality adjusted life year
4. Acceptability of the interventions (qualitative interviews and focus groups)
5. Change in self-reported physical activity from the questionnaire [General Practice Physical Activity Questionnaire (GPPAQ), International Physical Activity Questionnaire (IPAQ)]
6. Change in other patient reported outcomes from the questionnaire (exercise self-efficacy, anxiety, depression, perceived health status including mood and pain (EuroQol 5D [EQ-5D])
7. Change in anthropometric measurements (weight, body mass index, waist circumference, body fat, bio-impedence (Tanita scales)
8. Adverse outcomes (data on falls, injuries, major cardiovascular disease events and deaths will be collected as part of safety monitoring for the trial, through participant and nurse reporting, questionnaires at 3 and 12 months and primary care records
9. Health service use - number of and diagnoses for all primary care consultations during the 12 months of the trial, as well as any out of hours, A&E or in-patient attendances related to falls, injuries, fractures etc from computerised primary care records at the end of the study given participants consent.
10. There will be a range of outcomes from qualitative interviews and focus groups for both participants and practice nurses involved in implementing the intervention. We will gain an in-depth understanding of the acceptability and challenges with the interventions for participants and practice nurses, as well as valuable insights into the factors influencing why people opt not to participate in the intervention.

Overall trial start date

01/10/2012

Overall trial end date

30/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 45-74 years registered at one of the six general practices within the South West London cluster of primary care trusts (PCTs) where the research is being undertaken
2. Able to walk outside the home and with no contraindications to increasing their moderate intensity physical activity levels

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

993

Participant exclusion criteria

1. Those reporting achieving the Chief Medical Officers' guidelines of at least 150 minutes of at least moderate intensity physical activity weekly. We anticipate that there will be a few participants who will be found on subsequent baseline accelerometer assessment to be above this level of physical activity (our previous pilot work suggests this number will be small as most people tend to overestimate their physical activity levels). They will not be excluded from the study, as this is a pragmatic trial and if this intervention were to be rolled out, exclusion would be on the basis of the screening question alone.
2. Liiving in a residential or nursing home
3. Housebound
4. Three or more falls in previous year or one or more fall in previous year requiring medical attention
5. Terminal illness
6. Dementia or significant cognitive impairment (unable to follow simple instructions)
7. Registered blind
8. New onset chest pain
9. Myocardial infarction
10. Coronary artery bypass graft or angioplasty within the last 3 months
11. Medical or psychiatric condition which the general practitioner (GP) considers excludes the patient (e.g. acute systemic illness such as pneumonia, acute rheumatoid arthritis, unstable or acute heart failure, significant neurological disease or impairment, unable to move about independently, psychotic illness)
12. Pregnant women

Recruitment start date

01/10/2012

Recruitment end date

30/09/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St George's University of London
London
SW17 0RE
United Kingdom

Sponsor information

Organisation

St George's University of London (UK)

Sponsor details

c/o Lisa Clutterbuck
Research Officer
Joint Research Office
Cranmer Terrace
Tooting
London
SW17 0RE
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme (10/32/02)

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

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

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24304838
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25511452
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26654223
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27039181

Publication citations

  1. Protocol

    Harris T, Kerry SM, Victor CR, Shah SM, Iliffe S, Ussher M, Ekelund U, Fox-Rushby J, Whincup P, David L, Brewin D, Ibison J, DeWilde S, Limb E, Anokye N, Furness C, Howard E, Dale R, Cook DG, PACE-UP (Pedometer and consultation evaluation--UP)--a pedometer-based walking intervention with and without practice nurse support in primary care patients aged 45-75 years: study protocol for a randomised controlled trial., Trials, 2013, 14, 418, doi: 10.1186/1745-6215-14-418.

  2. Results

    Normansell R, Smith J, Victor C1, Cook DG, Kerry S, Iliffe S, Ussher M, Fox-Rushby J, Whincup P, Harris T, Numbers are not the whole story: a qualitative exploration of barriers and facilitators to increased physical activity in a primary care based walking intervention, BMC Public Health, 2014 , 14, 1272, doi: 10.1186/1471-2458-14-1272.

  3. Results

    "It's not just about walking.....it's the practice nurse that makes it work": a qualitative exploration of the views of practice nurses delivering complex physical activity interventions in primary care, BMC Public Health, 2015 , 15, 1, 1236.

  4. Results

    Normansell R, Holmes R, Victor C, Cook DG, Kerry S, Iliffe S, Ussher M, Fox-Rushby J, Whincup P, Harris T, Exploring non-participation in primary care physical activity interventions: PACE-UP trial interview findings., Trials, 2016, 17, 1, 178, doi: 10.1186/s13063-016-1299-z.

Additional files

Editorial Notes

04/04/2016: Publication reference added.