Physical ActivityNCT02596672
Promoting Walking in Older Adults Living in Independent Living Communities in Northern Ireland: A Feasibility Study.
A study testing The friendly walking group in people with Physical Activity and Aging, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
The multi-level 12 week peer-led walking intervention incorporates aspects from all three levels of the ecological model (with the aim of producing sustained (>6months) physical activity behaviour change in older adults living in independent living communities. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Aging, Health Behaviour
- What is being tested?
- The friendly walking group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults over the age of 60 years recruited from fold housing associations, dependent on site; those receiving nursing care will not be included.
- Inactive/not regularly walking (less than 30 minutes
- Have the ability to read, write, understand and speak English.
- Can walk freely without human assistance (residents will be included they use a walking stick/walking aid.)
Who cannot join
- If they have fallen in the last 6 months
- Have regular nursing assistance/care within the fold
- Residents with dementia or other cognitive challenges will be excluded.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Public Health, Queen's University Belfast
Belfast, BT12 6BJ
About this study
The multi-level 12 week peer-led walking intervention incorporates aspects from all three levels of the ecological model (with the aim of producing sustained (>6months) physical activity behaviour change in older adults living in independent living communities.
Read the detailed description
The proposed study is a cluster randomized controlled feasibility trial of a multi-level peer-led walking intervention. The socio-ecological model and social cognitive theory provides the framework that will help inform and test the feasibility of a multi-level peer-led walking intervention for inactive older adults living in independent living communities in Northern Ireland. The behaviour change techniques identified and extracted from a previous systematic review on the effectiveness of peer-led physical activity interventions helped guide the decision-making process of which behavior change strategies should be included in this study. The logic model helped inform the design and development of the 12 week peer-led walking programme.
- Conditions
- Physical Activity, Aging, Health Behaviour, Social Isolation
- Being tested
- The friendly walking group
- Keywords
- physical activity, older adults, retirement homes, walking, feasibility study
- Medical subject headings
- Motor Activity, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The friendly walking groupBehavioural
A 12 week peer led walking group for adults and older adults (> 55 years) living in independent living communities in Northern Ireland. Designed to increase physical activity levels of inactive older adults and measure sustained changes in physical behaviour 6 months after the intervention ends.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | They will complete a 12-week peer-led walking programme. Participants will be paired together as walking partners and will be given a pedometer and step count logs for self-monitoring. The walking co-ordinators will facilitate walking groups two times a week in the local areas, lasting for 30 minutes. The nature of the walks will be tailored to the participants stated preferences of types of activity. Participants will also receive local walking route maps. After 12 weeks, the formal peer-led component will finish and participants will be encouraged to continue walking with their walking partners other activity programmes organised in the fold in order to maintain activity levels. Receives: Behavioral: The friendly walking group |
| Control | No intervention | Folds assigned to the control group will not receive any additional support to change their physical activity behaviour over the course of the intervention period. At the six-month data collection point they will be offered a referral to a local walking group in their area or advice on beginning a self-directed walking programme (similar to Public Health Agency www.choosetolivebetter.com/content/getting-active). They will be asked to complete outcome measures at baseline and follow up time-points. Post-study a sample of control participants will be asked to attend a focus group, exploring their views on social activity as form of physical activity for older adults in folds. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate-to-vigorous physical activity (MVPA)
Changes from baseline MVPA as assessed by Actigraph accelerometer
Measured: Baseline, 12 weeks and 6 months
Secondary outcomes (4)
Quality of Life
To explore changes in health-related quality of life, a validated self-reported questionnaire EuroQol-5D will be completed by study participants.
Measured: Baseline, 12 weeks and 6 months
Self-efficacy
Changes in self-efficacy will be measured using a short version of exercise behaviour self-confidence questionnaire.
Measured: Baseline, 12 weeks and 6 months
Physical and Mental Health
Changes in other health-related and well-being outcomes will include completing the (7 item) Warwick-Edinburgh Mental Well-being score.
Measured: Baseline, 12 weeks and 6 months
Social Engagement
Changes in social engagement will be measured using the Lubben social network scale
Measured: Baseline, 12 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mark Tully, Queen's University, Belfast
- Investigators
- Mark A Tully, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596672
- Sponsor's protocol ID
- 15.30
- Status last verified
- Sep 2017
- First submitted
- 2 Nov 2015
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Walking in Older Adults Living in Independent Living Communities in Northern Ireland: A Feasibility Study.
- ClinicalTrials.gov ID
- NCT02596672
- Acronym / sponsor ID
- 15.30
- Conditions
- Physical Activity, Aging, Health Behaviour, Social Isolation
- Keywords
- physical activity, older adults, retirement homes, walking, feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The multi-level 12 week peer-led walking intervention incorporates aspects from all three levels of the ecological model (with the aim of producing sustained (>6months) physical activity behaviour change in older adults living in independent living communities.
Detailed description
The proposed study is a cluster randomized controlled feasibility trial of a multi-level peer-led walking intervention. The socio-ecological model and social cognitive theory provides the framework that will help inform and test the feasibility of a multi-level peer-led walking intervention for inactive older adults living in independent living communities in Northern Ireland. The behaviour change techniques identified and extracted from a previous systematic review on the effectiveness of peer-led physical activity interventions helped guide the decision-making process of which behavior change strategies should be included in this study. The logic model helped inform the design and development of the 12 week peer-led walking programme.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: The friendly walking groupThey will complete a 12-week peer-led walking programme. Participants will be paired together as walking partners and will be given a pedometer and step count logs for self-monitoring. The walking co-ordinators will facilitate walking groups two times a week in the local areas, lasting for 30 minutes. The nature of the walks will be tailored to the participants stated preferences of types of activity. Participants will also receive local walking route maps. After 12 weeks, the formal peer-led component will finish and participants will be encouraged to continue walking with their walking partners other activity programmes organised in the fold in order to maintain activity levels. |
| Control | No intervention | –Folds assigned to the control group will not receive any additional support to change their physical activity behaviour over the course of the intervention period. At the six-month data collection point they will be offered a referral to a local walking group in their area or advice on beginning a self-directed walking programme (similar to Public Health Agency www.choosetolivebetter.com/content/getting-active). They will be asked to complete outcome measures at baseline and follow up time-points. Post-study a sample of control participants will be asked to attend a focus group, exploring their views on social activity as form of physical activity for older adults in folds. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults over the age of 60 years recruited from fold housing associations, dependent on site; those receiving nursing care will not be included.
- Inactive/not regularly walking (less than 30 minutes
- Have the ability to read, write, understand and speak English.
- Can walk freely without human assistance (residents will be included they use a walking stick/walking aid.)
Key exclusion criteria (3 listed)
- If they have fallen in the last 6 months
- Have regular nursing assistance/care within the fold
- Residents with dementia or other cognitive challenges will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The friendly walking groupA 12 week peer led walking group for adults and older adults (> 55 years) living in independent living communities in Northern Ireland. Designed to increase physical activity levels of inactive older adults and measure sustained changes in physical behaviour 6 months after the intervention ends. | Behavioural | Intervention |
Primary outcome
Moderate-to-vigorous physical activity (MVPA)
Time frame: Baseline, 12 weeks and 6 months
Changes from baseline MVPA as assessed by Actigraph accelerometer
4 secondary outcomes
Quality of Life
Time frame: Baseline, 12 weeks and 6 months
Self-efficacy
Time frame: Baseline, 12 weeks and 6 months
Physical and Mental Health
Time frame: Baseline, 12 weeks and 6 months
Social Engagement
Time frame: Baseline, 12 weeks and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Tully, PhD principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The friendly walking group in people with Physical Activity and Aging, run by Queen's University, Belfast at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate-to-vigorous physical activity (MVPA) (time frame: Baseline, 12 weeks and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.