Condition category
Not Applicable
Date applied
05/10/2009
Date assigned
30/11/2009
Last edited
13/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.sparcoll.org.uk/Research/WestEndWalkers65.aspx

Contact information

Type

Scientific

Primary contact

Prof Nanette Mutrie

ORCID ID

Contact details

Department of Sport
Culture and the Arts
University of Strathclyde
76 Southbrae Drive
Glasgow
G13 1PP
United Kingdom
+44 (0)141 9503371
nanette.mutrie@strath.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CZH/4/457

Study information

Scientific title

The feasibility of a pedometer-based walking programme in combination with a physical activity consultation in Scottish adults aged 65 years and over in a primary care setting: a randomised controlled trial

Acronym

WEW 65+

Study hypothesis

Walking has been identified as an ideal mode of exercise to promote physical activity in the general population as well as among older adults. Large knowledge gaps exist on the optimum methods to promote and sustain walking behaviour in older adults. WEW 65+ will investigate the feasibility of a pedometer-based walking programme in combination with a physical activity consultation delivered in primary care. Its target is to help community dwelling older adults aged over 65 years achieve and sustain the physical activity recommendation of 30 minutes of activity at least 5 days of the week. This study will provide evaluative information on recruitment and retention to the study, the feasibility of the intervention and outcome measures that could be useful in designing a definitive randomised controlled trial.

Hypothesis:
Can a pedometer-based walking programme, in combination with a physical activity consultation delivered in a primary care setting increase and maintain walking behaviour among adults aged over 65 years over a 24 week period?

Ethics approval

NHS Greater Glasgow and Clyde Research Ethics Committee, approved on 26/11/2008 (ref: 08/S0701/121)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Not Specified

Patient information sheet

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

Condition

Physical activity in older adults

Intervention

Participants will be randomised into one of two groups: immediate intervention (Group 1) or waiting list control (Group 2). Participants randomised to Group 1 received a 30 minute physical activity consultation with a practice nurse. The participants are given an individualised 12 week walking programme, a pedometer and a booklet containing health advice, walking information and the walking programme. Following the 12 week walking programme, the participants will receive a second individual physical activity consultation focusing on relapse prevention. Participants will receive a written physical activity advice leaflet at this point.

Participants randomised to Group 2 were allocated to a 12 week waiting list and will be requested not to amend their current physical activity levels. After 12 weeks Group 2 received an individualised 12 week walking programme identical to Group 1, a pedometer and a physical activity consultation.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Walking behaviour will be assessed using pedometer step counts (NL-1000 pedometer) and accelerometer activity counts (ActivPAL Accelerometer). In the intervention group these measures will be assessed at baseline, 3 months and 6 months. In the waiting list group these measures will be assessed at baseline, 3 months and 6 months.

Secondary outcome measures

Psychological, including the changes in:
1. Mood: Positive And Negative Affects Scale (PANAS)
2. Loneliness: University of California, Los Angeles (UCLA) loneliness scale
3. Motor efficacy: perceived motor efficacy scale
4. Quality of life: SF-36v2™ Health Survey (SF-36v2™)

In the intervention group these questionnaires were completed at baseline and 12 weeks. In the waiting list group the questionnaires were completed at baseline, 12 weeks, 24 weeks and 36 weeks.

Qualitative:
Two focus groups will be completed with Group 1 at 12 weeks and 24 weeks (post intervention), one involving high adherers, the other of low adherers. A further two focus groups will be conducted with Group 2 at 24 weeks (post intervention), again one consisting of high adherers, the other of low adherers.

Overall trial start date

30/11/2008

Overall trial end date

30/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Independently living men and women aged over 65 years are eligible to enter the trial should they not currently meet the amount of physical activity currently recommended for health benefit.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

46

Participant exclusion criteria

1. Refusal to take part
2. Already achieved the physical activity recommendations for this group
3. Unable to walk outside independently
4. Unable to understand the rationale behind the trial

Recruitment start date

30/11/2008

Recruitment end date

30/09/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Sport, Culture and the Arts
Glasgow
G13 1PP
United Kingdom

Sponsor information

Organisation

Chief Scientist Office (UK)

Sponsor details

The Scottish Government
St Andrew's House
Regent Road
Edinburgh
EH1 3DG
United Kingdom

Sponsor type

Government

Website

http://www.sehd.scot.nhs.uk/cso/

Funders

Funder type

Government

Funder name

Chief Scientist Office (UK) (grant no: CZH/4/457)

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Funder name

NHS Greater Glasgow and Clyde Research and Development Office (UK) (project ref: WN08CH356)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22843637

Publication citations

  1. Results

    Mutrie N, Doolin O, Fitzsimons CF, Grant PM, Granat M, Grealy M, Macdonald H, MacMillan F, McConnachie A, Rowe DA, Shaw R, Skelton DA, Increasing older adults' walking through primary care: results of a pilot randomized controlled trial., Fam Pract, 2012, 29, 6, 633-642, doi: 10.1093/fampra/cms038.

Additional files

Editorial Notes