A randomised controlled trial of the effectiveness of pedometers plus systematic advice to increase physical activity levels in sedentary older women
| ISRCTN | ISRCTN26786857 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26786857 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/05/2007
- Registration date
- 03/08/2007
- Last edited
- 17/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Studies have shown that increasing physical activity levels, especially through increasing walking, can protect older people from developing mobility loss. Increasing physical activity can also reduce the risk of diseases like obesity, diabetes, stroke, heart problems, osteoporosis, depression and Alzheimer’s disease. It is not known which way is the best to change people’s behaviour and help them to become more active. The aim of this study is to see whether simple measures including advice about how to increase activity levels and setting out an activity plan will help people increase their physical activity. The study will also check if using a pedometer (a small device that is worn around the neck or at the waistband that counts the number of steps taken) to set targets will help people further increase their activity levels.
Who can participate?
Women aged 70 or over who are insufficiently active or sedentary
What does the study involve?
The study lasts for 6 months during which time the study nurse and research assistant will arrange to visit participants at home on five occasions. Participants are randomly allocated to one of three groups. Participants in the first group are asked to wear a pedometer for 6 months and to fill in a daily activity diary. They are also given advice on how to increase their physical activity levels and an activity plan designed to suit their needs. Participants in the second group are given the advice and activity plan only. Participants in the third group receive nothing. At the beginning of the study, the middle and again at the end of the study 6 months later, all participants undergo a walking test, a balance test, and a standing and sitting down test, and complete four questionnaires about how well they feel, how often they need to attend their GP surgery, their mood, and how well they have managed to follow their ‘Activity Plan’. These take about ten minutes to complete with the research assistant. Participants keep a record of any falls and what might have caused these. Participants who receive a pedometer are asked to walk 100 steps to check whether the pedometer works best worn on the waistband or around the neck. They are also asked to keep a record of the number of steps recorded each day on the pedometer. They are encouraged to gradually increase the number of steps they take every day. At the end of the study they are allowed to keep the pedometers for their own use. Irrespective of whether or not they are asked to wear a pedometer, all the women in the study are asked to wear a second device called an accelerometer on three occasions for periods of one week during the first, middle and last weeks of the study. The accelerometer is a small device about the size and shape of a small matchbox which tells us about their overall total activity. Participants have five home visits over the course of the study that last about 40 minutes each, two visits from the study nurse and three from the research assistant. Between the first and last visit, the study nurse contacts them by telephone to find out about how they are managing with their activity plan. For the first month they contact them every week and for the rest of the study they telephone fortnightly.
What are the possible benefits and risks of participating?
Increasing physical activity levels, especially through increasing walking, can protect older people from developing mobility loss. Increasing physical activity can also reduce the risk of diseases like obesity, diabetes, stroke heart problems, osteoporosis, depression and Alzheimer’s disease. It is hoped that the physical activity advice will prove beneficial. This study aims at increasing physical activity levels. Too rapid an increase can lead to mild tiredness. Participants are encouraged to increase their physical activity levels gradually and appropriate targets are set.
Where is the study run from?
University of Dundee (UK)
When is the study starting and how long is it expected to run for?
August 2007 to October 2009
Who is funding the study?
Chief Scientist Office (UK)
Who is the main contact?
Prof. Marion McMurdo
m.e.t.mcmurdo@dundee.ac.uk
Contact information
Scientific
Section of Ageing and Health
Division of Medicine and Therapeutics
University of Dundee
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
| Phone | +44 (0)1382 632436 |
|---|---|
| m.e.t.mcmurdo@dundee.ac.uk |
Study information
| Study design | Randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised controlled trial of the effectiveness of pedometers plus systematic advice to increase physical activity levels in sedentary older women |
| Study acronym | METM Pedometer study |
| Study objectives | To evaluate the use of pedometers plus brief systematic advice and individualised activity plans in assisting sedentary older women to accumulate increasing amounts of physical activity, mainly through walking. |
| Ethics approval(s) | Tayside Committee on Medical Research Ethics B, ref: 07/S1402/33 |
| Health condition(s) or problem(s) studied | Sedentary women over 70 years of age |
| Intervention | The participants will be randomised to one of the following 3 arms: Arm 1: Advice and pedometer Arm 2: Advice only Arm 3: Control group Arms 1 and 2 receive tailored advice at the baseline session from a nurse visiting the participant at home. They will be encouraged to incorporate more walking into their daily routine. They will be given monthly targets to achieve (in pedometer counts for Arm 1 and in time spent walking outdoors for Arm 2). Both arms will be given daily activity diaries to complete (of pedometer count for Arm 1 and of time spent walking outdoors for Arm 2). They will receive telephone support weekly for the first month then fortnightly thereafter. The control group receives no intervention. |
| Intervention type | Other |
| Primary outcome measure | Change in daily activity levels by accelerometry |
| Secondary outcome measures | The following will be assessed at baseline, 3 and 6 months: 1. Lower limb function (a validated 12-point performance score) 2. Health related quality of life (the Euroquol questionnaire) 3. Depression (the Hospital Anxiety and Depression Scale ([HADS]) |
| Overall study start date | 13/08/2007 |
| Completion date | 14/10/2009 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Senior |
| Sex | Female |
| Target number of participants | 210 |
| Key inclusion criteria | 1. Women aged 70 years or over 2. Insufficiently active or sedentary (no participation in moderate-intensity physical activity of at least 30 minutes at least 5 days per week, or at least 20 minutes of continuous vigorous-intensity activity 3 or more times per week) |
| Key exclusion criteria | 1. Women fulfilling recommended physical activity recommendations 2. Resident of institutional care 3. Housebound (so unable to increase outdoor walking) 4. Moderate to severe cognitive impairment precluding informed consent 5. Visually impaired (unable to read pedometer count) 6. Wheelchair bound 7. Unwilling to participate |
| Date of first enrolment | 13/08/2007 |
| Date of final enrolment | 14/10/2009 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
DD1 9SY
United Kingdom
Sponsor information
University/education
Research and Innovation Services
11 Perth Road
Dundee
DD1 4HN
Scotland
United Kingdom
| Phone | +44 (0)1382 344436 |
|---|---|
| research@dundee.ac.uk | |
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | The protocol is available from the authors on request but is not available online. Study data are available for non-commercial, bona-fide academic analyses in collaboration with the authors; decisions on data access will be made between the investigators and the Sponsor (University of Dundee). Participant consent for unrestricted sharing of individual participant data was not obtained. Contact for data sharing: Dr Catrina Forde (c.forde@dundee.ac.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2010 | Yes | No | |
| Basic results | 17/05/2018 | 17/05/2018 | No | No |
Additional files
- ISRCTN26786857_BasicResults_17May18.pdf
- Uploaded 17/05/2018
Editorial Notes
17/05/2018: IPD sharing statement and plain English summary added. The basic results of this trial have been uploaded as an additional file.
