Condition category
Not Applicable
Date applied
29/05/2007
Date assigned
03/08/2007
Last edited
24/08/2012
Prospective/Retrospective
Prospectively 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

Prof Marion McMurdo

ORCID ID

Contact details

Section of Ageing and Health
Division of medicine and Therapeutics
University of Dundee
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 632436
m.e.t.mcmurdo@dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

METM Pedometer study

Study hypothesis

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

Favourable ethical opinion received from Tayside Committee on Medical Research Ethics B (ref: 07/S1402/33)

Study design

Randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

13/08/2007

Overall trial end date

14/10/2009

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Senior

Gender

Female

Target number of participants

210

Participant 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

Recruitment start date

13/08/2007

Recruitment end date

14/10/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Section of Ageing and Health
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

Research and Innovation Services
11 Perth Road
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 344436
research@dundee.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Chief Scientist Office (UK)

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21054290

Publication citations

  1. Results

    McMurdo ME, Sugden J, Argo I, Boyle P, Johnston DW, Sniehotta FF, Donnan PT, Do pedometers increase physical activity in sedentary older women? A randomized controlled trial., J Am Geriatr Soc, 2010, 58, 11, 2099-2106, doi: 10.1111/j.1532-5415.2010.03127.x.

Additional files

Editorial Notes