Older Adults With Decreased Outdoor Walking AbilityGO-OUTNCT02339467
Getting Older Adults OUT-of -Doors
A study testing GO-OUT program and Task-oriented outdoor walking workshop in people with Older Adults With Decreased Outdoor Walking Ability, run by University of Manitoba at 1 site in Canada.
Trial summary
Community walking is an issue that older adults with chronic conditions have described as important to participation in the community. Walking outside the home is a universally accessible form of physical activity that has multiple health benefits. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults With Decreased Outdoor Walking Ability
- What is being tested?
- GO-OUT program and Task-oriented outdoor walking workshop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Nov 2015
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- self-reported ability to walk continuously on a flat surface a distance of ≥1 block (~50 metres or 164 feet) independently with or without a walking aid and without supervision
- outdoor walking limitation defined as self-reportedly accumulating ≤20 minutes of outdoor walking in a typical week
- mental competency indicated by a score of ≥18 on the telephone version of the Mini-mental State Exam
Who cannot join
- active walkers defined as accumulating ≥100 minutes of total (indoor and outdoor) walking per week
- have had ≥2 falls in the prior 12 months or present with an acute fall (based on American Geriatric Society fall guidelines)
- cardiac, respiratory, peripheral vascular or other health conditions that would prevent safe and full participation in the interventions
- currently receiving rehabilitation treatment such as physical or occupational therapy for goals related to walking
- postural hypotension determined by measuring lying and standing blood pressure
- severe limitations to visual acuity by a falls prevention screen
- resting heart rate under 45 or over 100.
- The PAR-Q+ (an evaluation of exercise readiness) will be completed by each participant. With participants' permission, their family physician will be asked to review the PAR-Q+ and confirm readiness to participate in exercise.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Manitoba College of Rehabilitation Sciences
Winnipeg, Manitoba, R3E 0W3
About this study
Official title: Getting Older Adults OUT-of-doors (GO-OUT): A Randomized Controlled Trial of a Community-based Outdoor Walking Program
Community walking is an issue that older adults with chronic conditions have described as important to participation in the community. Walking outside the home is a universally accessible form of physical activity that has multiple health benefits. Walking for 150 minutes per week can help reduce the risk of cardiovascular disease, hypertension, stroke, diabetes, osteoporosis, and depression, as well as falls. Practice walking across roads, slopes and curbs, while talking, and dealing with crowds and traffic, is safe and feasible and can improve confidence, balance and walking ability. Being physically active outdoors in nature appears to improve mental health more than being active indoors. Despite these health benefits, the majority of older Canadians do not walk outside on a regular basis. Barriers to walking outside include fear, physical disability due to chronic disease, the appropriateness of footwear and walking aids, and the physical environment, such as uneven pavement, weather and temperature. To date, the best strategy for getting people to walk outdoors regularly is unknown. The investigators propose to evaluate the effectiveness of a dynamic 1-day workshop, at which older adults who infrequently walk outdoors learn strategies to facilitate outdoor walking, such as appropriate use of footwear, ambulatory aids and equipment, goal setting, and practice skills related to increasing outdoor walking. The workshop will be compared to the workshop plus involvement in a walking group for 3 months. Outcomes include outdoor walking activity, total physical activity, walking ability, participation, and health-related quality of life. Each participant will have three evaluations: before the intervention and 3 and 6 months later. The investigators will interview select participants at 6 months to ask them about their opinions of what worked and didn't work. Increasing outdoor walking is expected to improve health and well-being, and help people live independently in the community for longer.
Read the detailed description
Background: Inability to walk outdoors restricts full participation in physical activity and community living for older adults that can reduce health-related quality of life (HRQL). Older adults report limited outdoor walking with only 8% achieving the Canadian recommendation for older adults of 150 minutes of moderate-to-vigorous (MV) intensity physical activity per week. Known barriers to walking outside include fear, physical disability due to chronic disease, the appropriateness of footwear and walking aids, the physical environment, weather and temperature. Group practice walking outdoors in locations with variable environmental challenges has the potential to improve physical ability, confidence, outdoor and overall physical activity and social participation. The extent to which it is safe and feasible to implement this intervention in people with varying degrees of physical ability, preferences for where to walk, neighbourhood walkability, and to measure outdoor walking activity, is unclear.
Objectives: The study purpose is to evaluate the feasibility of a randomized controlled trial (RCT) protocol designed to evaluate the effectiveness of an education and skills workshop plus a 3-month outdoor walking group (GO-OUT program) compared to the workshop alone in improving outdoor walking activity. Specific objectives are to characterize participants; determine the feasibility of recruitment; estimate withdrawal rates and the safety and feasibility of the study protocol; obtain preliminary effect sizes; identify the optimal measure of outdoor walking activity based on validity, reliability, effect size and data completeness; and identify participants' and intervention facilitators' perceptions of the challenges and benefits of the intervention and evaluation tools.
Methods: Design and Participants-A feasibility RCT with an embedded qualitative component is proposed with 18 participants. Ambulatory older adults living in the community who report walking outdoors ≤20 minutes/week will be stratified by level of walking impairment (gait speed<0.8 m/s vs ≥0.8 m/s) and randomly assigned to receive the GO-OUT program or the workshop alone. Group allocation will be concealed. A blinded evaluator will evaluate participants at baseline, 3 and 6 months. At 6 months, focus groups of participants from the GO-OUT and workshop groups and intervention facilitators, will participate in a semi-structured interview to explore perceived benefits and challenges of adherence, intervention strategy and outcome measures. Interventions-The workshop will include activity stations at which people will learn about appropriate footwear, walking aids and equipment (pedometers, Nordic poles), goal setting, physical activity recommendations/benefits and practice walking-related tasks. The GO-OUT program will include the workshop plus the outdoor walking group. The walking group will be supervised and consist of 9 participants; they will meet twice a week for 1 hour to walk in increasingly challenging environments to achieve individualized goals. Outcome Measures-Outdoor walking (primary outcome) will be measured by 2 methods: outdoor walking items of the Community Health Activities Model Program for Seniors (CHAMPS) (self-report) and accelerometer/Global Positioning System (GPS). Overall physical activity (secondary outcome) will be measured with the CHAMPS (self-report) as well as accelerometry. Measures of aerobic capacity, walking competency, mood, participation, and HRQL will also be administered. Neighbourhood walkability will be assessed with the Neighbourhood Environment Walkability Scale (self-report). Analysis-This is a feasibility study; therefore, no hypotheses will be tested. The analysis will include describing participant characteristics, estimating recruitment, withdrawal and adverse event rates, estimating preliminary effect sizes for outcome measures, estimating test-retest reliability of outdoor walk time derived from the CHAMPS and construct validity and data completeness of outdoor walk time derived from the CHAMPS and accelerometry/GPS. A qualitative descriptive approach will be used to analyse the interview data. Conclusion-Increasing outdoor walking is expected to help people improve physical activity, the ability to live independently in the community, and health and well-being. This study will evaluate the feasibility of a trial protocol aimed at improving outdoor walking. Findings will be used to justify and inform planning of a future definitive multi-site trial.
- Being tested
- GO-OUT program, Task-oriented outdoor walking workshop
- Keywords
- decreased outdoor walking ability, Older adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GO-OUT programOther
Participants attend the walking workshop followed by a 3-month outdoor walking group intervention, twice weekly for 60-minutes. Each session includes a 10-minute warm-up and cool down, and a planned walk in an outdoor community environment. Continuous walking exercise will gradually increase from 10 to 60 minutes, as well increase difficulty. Balance exercises will be included in the warmup and walk. There will be a variety of surfaces and environmental factors to challenge the participants, e.g., carrying objects, diverting the walker's attention, crossing at a light, walking up and down curbs, slopes, and level or uneven surfaces. Supervision will be on a 1:3 facilitator-to-participant ratio to allow for assistance and individualization of the intervention where necessary.
Task-oriented outdoor walking workshopOther
The 1-day workshop will be 5 hours with breaks. Participants will complete a series of stations learning information, strategies and skills related to safely walking outdoors. Stations include: pedometer use; walking pole use; footwear; footcare; fall prevention; balance exercises; proper use of walking aids; correct posture; self-management of exercise intensity; goal setting; and walking safely outdoors. Participants will receive a workbook with Canadian Physical Activity Guidelines, benefits of outdoor walking, information for each workshop station and a pedometer. Participants will use the workbook as an information resource and to record their community ambulation goals, planning routes, and walking time. All participants will be encouraged to walk outside with a partner, for safety.
| Study group | Role | What they receive |
|---|---|---|
| GO-OUT program | Experimental | An outdoor walking workshop with stations to learn various outdoor walking skills and information, followed by a supervised, group based outdoor walking program, twice a week for 60 minutes, for 3 months. Receives: Other: GO-OUT program |
| Task-oriented outdoor walking workshop | Active comparator | An outdoor walking workshop with stations to learn various outdoor walking skills and information. Receives: Other: Task-oriented outdoor walking workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Outdoor walking activity - CHAMPS questionnaire
Self-report measure designed to evaluate interventions to increase physical activity among older persons. Will determine number of minutes at moderate to vigorous intensity of walking outdoors per week by focusing on 4 walking items.
Measured: baseline, 3,6 months
Change in Outdoor walking activity -GPS data
Participants will wear the GlobalSat DG-200 Data Logger (www.gpscentral.ca/products/usglobalsat/dg200.html) clipped onto their waist band from the time they first get out of bed in the morning until they return to bed in the evening, removing it for showering, bathing, and swimming, for 14 days. Will determine The number of minutes spent walking per week outdoors.
Measured: baseline, 3,6 months
Change in Outdoor walking activity -Accelerometry
The ActiGraph GT3X+ monitor (www.actigraphcorp.com/products/wgt3x-monitor/, ActiGraph, Pensacola, FL) will be worn by each participant, clipped onto their waist band over the right hip on the anterior axillary line along with the GPS. Time spent in sedentary, light, moderate and high intensity PA categories/day will be calculated.
Measured: baseline, 3,6 months
Secondary outcomes (5)
Change in Aerobic capacity (Six minute walk test)
Six minute walk test - distance walked in 6 minutes.
Measured: baseline, 3,6 months
Change in Walking competency (Berg Balance scale)
Balance, lower limb strength, ambulation self-efficacy, and walking speed will be evaluated using the Berg Balance scale, the sit to stand test, the Ambulation Self-efficacy Scale, and the 10-metre walk test (gait speed), respectively.
Measured: baseline, 3,6 months
Change in Mood (Geriatric depression scale)
Geriatric depression scale. If a participant scores >9, they will not be excluded, but the family physician will be notified.
Measured: baseline, 3,6 months
Change in Health Related Quality of life (The Rand-36)
The Rand-36, self reported mental health and physical function.
Measured: baseline, 3,6 months
Change in Participation (CHAMPS)
Time in minutes per week spent performing all 40 social, leisure and physical activities described in the CHAMPS will be used in the analysis.
Measured: baseline, 3,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older Adults With Decreased Outdoor Walking AbilityStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, McGill University, University of Alberta
- Responsible party
- Sponsor
- Investigators
- Ruth Barclay, PhD, Principal investigator, University of ManitobaNancy Salbach, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339467
- Sponsor's protocol ID
- H2014:391
- Acronym
- GO-OUT
- Status last verified
- May 2016
- First submitted
- 7 Jan 2015
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barclay R, Webber S, Ripat J, Grant T, Jones CA, Lix LM, Mayo N, van Ineveld C, Salbach NM. Safety and feasibility of an interactive workshop and facilitated outdoor walking group compared to a workshop alone in increasing outdoor walking activity among older adults: a pilot randomized controlled trial. Pilot Feasibility Stud. 2018 Nov 29;4:179. doi: 10.1186/s40814-018-0367-4. eCollection 2018.
PubMed 30519481
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Getting Older Adults OUT-of-doors (GO-OUT): A Randomized Controlled Trial of a Community-based Outdoor Walking Program
- ClinicalTrials.gov ID
- NCT02339467
- Acronym / sponsor ID
- GO-OUT / H2014:391
- Keywords
- decreased outdoor walking ability, Older adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- University of Toronto, McGill University, University of Alberta
- Study start
- Feb 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 15 Jan 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.
Community walking is an issue that older adults with chronic conditions have described as important to participation in the community. Walking outside the home is a universally accessible form of physical activity that has multiple health benefits. Walking for 150 minutes per week can help reduce the risk of cardiovascular disease, hypertension, stroke, diabetes, osteoporosis, and depression, as well as falls. Practice walking across roads, slopes and curbs, while talking, and dealing with crowds and traffic, is safe and feasible and can improve confidence, balance and walking ability. Being physically active outdoors in nature appears to improve mental health more than being active indoors. Despite these health benefits, the majority of older Canadians do not walk outside on a regular basis. Barriers to walking outside include fear, physical disability due to chronic disease, the appropriateness of footwear and walking aids, and the physical environment, such as uneven pavement, weather and temperature. To date, the best strategy for getting people to walk outdoors regularly is unknown. The investigators propose to evaluate the effectiveness of a dynamic 1-day workshop, at which older adults who infrequently walk outdoors learn strategies to facilitate outdoor walking, such as appropriate use of footwear, ambulatory aids and equipment, goal setting, and practice skills related to increasing outdoor walking. The workshop will be compared to the workshop plus involvement in a walking group for 3 months. Outcomes include outdoor walking activity, total physical activity, walking ability, participation, and health-related quality of life. Each participant will have three evaluations: before the intervention and 3 and 6 months later. The investigators will interview select participants at 6 months to ask them about their opinions of what worked and didn't work. Increasing outdoor walking is expected to improve health and well-being, and help people live independently in the community for longer.
Detailed description
Background: Inability to walk outdoors restricts full participation in physical activity and community living for older adults that can reduce health-related quality of life (HRQL). Older adults report limited outdoor walking with only 8% achieving the Canadian recommendation for older adults of 150 minutes of moderate-to-vigorous (MV) intensity physical activity per week. Known barriers to walking outside include fear, physical disability due to chronic disease, the appropriateness of footwear and walking aids, the physical environment, weather and temperature. Group practice walking outdoors in locations with variable environmental challenges has the potential to improve physical ability, confidence, outdoor and overall physical activity and social participation. The extent to which it is safe and feasible to implement this intervention in people with varying degrees of physical ability, preferences for where to walk, neighbourhood walkability, and to measure outdoor walking activity, is unclear.
Objectives: The study purpose is to evaluate the feasibility of a randomized controlled trial (RCT) protocol designed to evaluate the effectiveness of an education and skills workshop plus a 3-month outdoor walking group (GO-OUT program) compared to the workshop alone in improving outdoor walking activity. Specific objectives are to characterize participants; determine the feasibility of recruitment; estimate withdrawal rates and the safety and feasibility of the study protocol; obtain preliminary effect sizes; identify the optimal measure of outdoor walking activity based on validity, reliability, effect size and data completeness; and identify participants' and intervention facilitators' perceptions of the challenges and benefits of the intervention and evaluation tools.
Methods: Design and Participants-A feasibility RCT with an embedded qualitative component is proposed with 18 participants. Ambulatory older adults living in the community who report walking outdoors ≤20 minutes/week will be stratified by level of walking impairment (gait speed<0.8 m/s vs ≥0.8 m/s) and randomly assigned to receive the GO-OUT program or the workshop alone. Group allocation will be concealed. A blinded evaluator will evaluate participants at baseline, 3 and 6 months. At 6 months, focus groups of participants from the GO-OUT and workshop groups and intervention facilitators, will participate in a semi-structured interview to explore perceived benefits and challenges of adherence, intervention strategy and outcome measures. Interventions-The workshop will include activity stations at which people will learn about appropriate footwear, walking aids and equipment (pedometers, Nordic poles), goal setting, physical activity recommendations/benefits and practice walking-related tasks. The GO-OUT program will include the workshop plus the outdoor walking group. The walking group will be supervised and consist of 9 participants; they will meet twice a week for 1 hour to walk in increasingly challenging environments to achieve individualized goals. Outcome Measures-Outdoor walking (primary outcome) will be measured by 2 methods: outdoor walking items of the Community Health Activities Model Program for Seniors (CHAMPS) (self-report) and accelerometer/Global Positioning System (GPS). Overall physical activity (secondary outcome) will be measured with the CHAMPS (self-report) as well as accelerometry. Measures of aerobic capacity, walking competency, mood, participation, and HRQL will also be administered. Neighbourhood walkability will be assessed with the Neighbourhood Environment Walkability Scale (self-report). Analysis-This is a feasibility study; therefore, no hypotheses will be tested. The analysis will include describing participant characteristics, estimating recruitment, withdrawal and adverse event rates, estimating preliminary effect sizes for outcome measures, estimating test-retest reliability of outdoor walk time derived from the CHAMPS and construct validity and data completeness of outdoor walk time derived from the CHAMPS and accelerometry/GPS. A qualitative descriptive approach will be used to analyse the interview data. Conclusion-Increasing outdoor walking is expected to help people improve physical activity, the ability to live independently in the community, and health and well-being. This study will evaluate the feasibility of a trial protocol aimed at improving outdoor walking. Findings will be used to justify and inform planning of a future definitive multi-site trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GO-OUT program | Experimental | Other: GO-OUT programAn outdoor walking workshop with stations to learn various outdoor walking skills and information, followed by a supervised, group based outdoor walking program, twice a week for 60 minutes, for 3 months. |
| Task-oriented outdoor walking workshop | Active comparator | Other: Task-oriented outdoor walking workshopAn outdoor walking workshop with stations to learn various outdoor walking skills and information. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- self-reported ability to walk continuously on a flat surface a distance of ≥1 block (~50 metres or 164 feet) independently with or without a walking aid and without supervision
- outdoor walking limitation defined as self-reportedly accumulating ≤20 minutes of outdoor walking in a typical week
- mental competency indicated by a score of ≥18 on the telephone version of the Mini-mental State Exam
Key exclusion criteria (8 listed)
- active walkers defined as accumulating ≥100 minutes of total (indoor and outdoor) walking per week
- have had ≥2 falls in the prior 12 months or present with an acute fall (based on American Geriatric Society fall guidelines)
- cardiac, respiratory, peripheral vascular or other health conditions that would prevent safe and full participation in the interventions
- currently receiving rehabilitation treatment such as physical or occupational therapy for goals related to walking
- postural hypotension determined by measuring lying and standing blood pressure
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 |
|---|---|---|
| GO-OUT programParticipants attend the walking workshop followed by a 3-month outdoor walking group intervention, twice weekly for 60-minutes. Each session includes a 10-minute warm-up and cool down, and a planned walk in an outdoor community environment. Continuous walking exercise will gradually increase from 10 to 60 minutes, as well increase difficulty. Balance exercises will be included in the warmup and walk. There will be a variety of surfaces and environmental factors to challenge the participants, e.g., carrying objects, diverting the walker's attention, crossing at a light, walking up and down curbs, slopes, and level or uneven surfaces. Supervision will be on a 1:3 facilitator-to-participant ratio to allow for assistance and individualization of the intervention where necessary. | Other | GO-OUT program |
| Task-oriented outdoor walking workshopThe 1-day workshop will be 5 hours with breaks. Participants will complete a series of stations learning information, strategies and skills related to safely walking outdoors. Stations include: pedometer use; walking pole use; footwear; footcare; fall prevention; balance exercises; proper use of walking aids; correct posture; self-management of exercise intensity; goal setting; and walking safely outdoors. Participants will receive a workbook with Canadian Physical Activity Guidelines, benefits of outdoor walking, information for each workshop station and a pedometer. Participants will use the workbook as an information resource and to record their community ambulation goals, planning routes, and walking time. All participants will be encouraged to walk outside with a partner, for safety. | Other | Task-oriented outdoor walking workshop |
Primary outcome
Change in Outdoor walking activity - CHAMPS questionnaire
Time frame: baseline, 3,6 months
Self-report measure designed to evaluate interventions to increase physical activity among older persons. Will determine number of minutes at moderate to vigorous intensity of walking outdoors per week by focusing on 4 walking items.
Change in Outdoor walking activity -GPS data
Time frame: baseline, 3,6 months
Participants will wear the GlobalSat DG-200 Data Logger (www.gpscentral.ca/products/usglobalsat/dg200.html) clipped onto their waist band from the time they first get out of bed in the morning until they return to bed in the evening, removing it for showering, bathing, and swimming, for 14 days. Will determine The number of minutes spent walking per week outdoors.
Change in Outdoor walking activity -Accelerometry
Time frame: baseline, 3,6 months
The ActiGraph GT3X+ monitor (www.actigraphcorp.com/products/wgt3x-monitor/, ActiGraph, Pensacola, FL) will be worn by each participant, clipped onto their waist band over the right hip on the anterior axillary line along with the GPS. Time spent in sedentary, light, moderate and high intensity PA categories/day will be calculated.
5 secondary outcomes
Change in Aerobic capacity (Six minute walk test)
Time frame: baseline, 3,6 months
Change in Walking competency (Berg Balance scale)
Time frame: baseline, 3,6 months
Change in Mood (Geriatric depression scale)
Time frame: baseline, 3,6 months
Change in Health Related Quality of life (The Rand-36)
Time frame: baseline, 3,6 months
Change in Participation (CHAMPS)
Time frame: baseline, 3,6 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 17 May 2017.
- Derived from this study: PubMed 30519481Barclay R, Webber S, Ripat J, Grant T, Jones CA, Lix LM, Mayo N, van Ineveld C, Salbach NM. Safety and feasibility of an interactive workshop and facilitated outdoor walking group compared to a workshop alone in increasing outdoor walking activity among older adults: a pilot randomized controlled trial. Pilot Feasibility Stud. 2018 Nov 29;4:179. doi: 10.1186/s40814-018-0367-4. eCollection 2018.
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.
Ruth Barclay, PhD principal investigator
University of Manitoba
Nancy Salbach, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GO-OUT program and Task-oriented outdoor walking workshop in people with Older Adults With Decreased Outdoor Walking Ability, run by University of Manitoba at 1 site in Canada.
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 3 inclusion and 8 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 17 May 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 Canada. 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?
Change in Outdoor walking activity - CHAMPS questionnaire (time frame: baseline, 3,6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02339467, which also lists 1 linked publication.
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 17 May 2017.