Condition category
Not Applicable
Date applied
25/10/2013
Date assigned
25/10/2013
Last edited
27/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
As people live longer, their risk of disability increases. Disability can affect quality of life and increase health and social care costs. It is therefore important to prevent or delay disability in the elderly by identifying an effective intervention to improve the lives of older people. There is evidence that physical activity may reduce the risk of age-related disability. Increasing physical activity levels in older adults is therefore important, but to date no physical activity intervention has been shown to substantially change physical activity behaviour in this age group. A new behavioural intervention known as Physical Activity Facilitation (PAF) has been developed for use with older adults. The aim of the programme is to keep older people active and independent as they age by encouraging individuals to incorporate physical activity into their everyday lives. This study aims to assess the feasibility of using the PAF intervention as a means of increasing physical activity and physical performance in older adults.

Who can participate?
Non-disabled inactive community-dwelling men and women aged 65 and older.

What does the study involve?
Participants will be randomly allocated into either the intervention group or the control group. Intervention group participants will receive up to three face-to-face visits and up to nine telephone support phone calls with a trained physical activity facilitator. Sessions will be delivered flexibly over a six-month period. Control group participants will receive written materials promoting a healthy lifestyle. Every participant will be invited back to a follow-up clinic after six months.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Primary care practices across Bristol and the surrounding areas (UK)

When is the study starting and how long is it expected to run for?
January to June 2014

Who is funding the study?
National Institute for Health Research (NIHR) and Avon Primary Care Research Collaborative (APCRC) (UK)

Who is the main contact?
Dr Gemma Morgan
gemma.morgan@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gemma Morgan

ORCID ID

Contact details

School of Social & Community Medicine
Canynge Hall
39 Whatley Road
Clifton
Bristol
BS8 2PS
United Kingdom
-
gemma.morgan@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15367

Study information

Scientific title

Physical activity facilitation to improve functional ability and independent living in older people at risk of disability: a feasibility study and exploratory pilot randomised controlled trial

Acronym

PACE

Study hypothesis

As people live longer, their risk of disability increases. Disability can affect quality of life and increase health and social care costs. Preventing or delaying disability in the elderly is therefore an important public health objective, and identifying an effective intervention could improve the lives of many older people.

There is evidence that physical activity may reduce the risk of age-related disability. Increasing levels in older adults is therefore important, however to date no physical activity intervention has been shown to substantially change physical activity behaviour in this population. A new theory-driven behavioural intervention, using physical activity facilitation, has been effective in producing a significant and sustained increase in physical activity in adults with depression. This programme aims to encourage people to incorporate physical activity into their everyday life. The programme is based on a psychological theory of behaviour called self determination theory (SDT). SDT proposes that real and sustained changes in behaviour only occur once an individual feels competent in the behaviour, autonomous in their decisions about that behaviour, and related or connected to others.

A similar physical activity programme, known as Physical Activity Facilitation (PAF), has been developed for use with older adults. The aim of the programme is to keep older people active and independent as they age. The programme lasts for six months and involves up to three face-to-face visits and up to nine telephone support phone calls between an individual and a physical activity facilitator. The present study aims to assess the feasibility of using this SDT-based intervention, customized for an older population, as a means of increasing physical activity and physical performance. Feasibility will be explored using a pilot randomized controlled trial design and will incorporate a mixed-methods process evaluation.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=15367

Ethics approval

13/YH/0319

Study design

Inteventional single-centre randomised controlled exploratory pilot trial; Design type: Prevention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

Intervention: Physical Activity Facilitation (PAF) involves:
1. Assessing current attitudes to physical activity and perceived barriers.
2. Utilising motivational interviewing techniques to engage the patient's own motivation to integrate physical activity into their lifestyle, rather than providing simple advice.
3. Negotiating and offering choice of physical activity modes and of rate of progression.
4. Using appropriate behavioural strategies to support changes in physical activity and to enhance self-efficacy.

Intervention arm participants will receive up to three face-to-face visits and up to nine telephone support phone calls with a trained physical activity facilitator (PAF). Sessions will be delivered flexibly throughout a six month period.

Control arm participants will receive age-appropriate written materials promoting a healthy lifestyle. These will be posted to participants during months one and four.

Every participant will be invited back to outcome measures at a follow-up clinic six months after they were randomised or six months after they received the first PAF session, whichever is the later.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Short Physical Performance Battery (SPPB); Timepoint(s): At baseline: month 0, at follow-up: month 6

Secondary outcome measures

1. Accelerometer data on physical activity; Timepoint(s): At baseline: month 0, at follow-up: month 6
2. Autonomy support; Timepoint(s): At baseline: month 0, at follow-up: month 6
3. Basic psychological needs; Timepoint(s): At baseline: month 0, at follow-up: month 6
4. Cognitive function (Montreal Cognitive Assessment); Timepoint(s): At baseline: month 0, at follow-up: month 6 5. Grip strength; Timepoint(s): At baseline: month 0, at follow-up: month 6
6. Health service utilisation from routine medical records; Timepoint(s): At baseline: month 0, at follow-up: month 6
7. Lawton scale of instrumental activities; Timepoint(s): At baseline: month 0, at follow-up: month 6
8. Mood (Geriatric Depression Scale); Timepoint(s): At baseline: month 0, at follow-up: month 6
9. Motivation for physical activity; Timepoint(s): At baseline: month 0, at follow-up: month 6
10. Physical activity outcome expectations scale; Timepoint(s): At baseline: month 0, at follow-up: month 6 10. Physical activity questionnaire (PASE); Timepoint(s): At baseline: month 0, at follow-up: month 6
11. Psychological Need Satisfaction in Exercise; Timepoint(s): At baseline: month 0, at follow-up: month 6
12. Quality of life (EQ-5D); Timepoint(s): At baseline: month 0, at follow-up: month 6
13. Social support; Timepoint(s): At baseline: month 0, at follow-up: month 6

Overall trial start date

01/01/2014

Overall trial end date

30/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female aged 65 years or older
2. Community-dwelling, including those in warden-controlled accommodation
3. Inactive: undertaking less than 150 minutes of moderate-to-vigorous physical activity per week
4. Non-disabled at baseline: able to complete a 4m walk at a speed of 0.8m/s or greater, without sitting, leaning, using walking aids or another person. This practical assessment is highly predictive (>90%) of successfully completing the well-established 400m walk test within 15 minutes
5. At risk of subsequent disability: scoring less than 10 out of 12 on the Short Physical Performance Battery (SPPB)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 60

Participant exclusion criteria

1. Unable to participate in the intervention or unable to complete the outcome assessments due to speech, language, or sensory problems
2. Resident in a nursing home
3. Plans to move outside of the study area within six months of the screening clinic visit or plans to be away for more than eight consecutive weeks during this period
4. Currently participating in exercise-on-prescription or a physical rehabilitation programme or study
5. A documented or patient-reported medical condition including but not limited to:
5.1. Severe uncontrolled arthritis, e.g. awaiting joint replacement, that would interfere with the ability to participate in the intervention arm
5.2. Lung disease requiring regular use of corticosteroids or of supplemental oxygen
5.3. Cardiovascular disease, including unstable angina, clinically significant valvular disease, uncontrolled and symptomatic cardiac arrhythmias, uncontrolled and symptomatic heart failure, suspected or known dissecting aneurysm
5.4. Past history of cardiac arrest or presence of an implantable cardiac defibrillator
5.5. Neuromuscular, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise
5.6. Moderate or severe cognitive impairment or dementia
5.7. Severe uncontrolled psychiatric illness
5.8. Multiple falls, i.e. two or more falls in the previous three months.
6. Investigator concern about an individual's safety or ability to adhere to the intervention if enrolled in the trial

Participants will not be medically screened for the above conditions, however they will be asked about the presence or absence of each condition on enrollment. It is important that no patient is inappropriately encouraged to participate in the trial and therefore the eligibility of each participant will be judged clinically by the investigator on a case-by-case basis.

Recruitment start date

01/01/2014

Recruitment end date

30/06/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Social & Community Medicine
Bristol
BS8 2PS
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Senate House
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR (UK) - Clinical Academic Training

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

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25872500

Publication citations

Additional files

Editorial Notes