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Older Adults With Decreased Outdoor Walking AbilityNCT03292510

Getting Older Adults OUTdoors (GO-OUT)

A study testing GO-OUT Group and Workshop Group in people with Older Adults With Decreased Outdoor Walking Ability, run by University of Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 to 100 yearsHealthy volunteers can take part
What is being tested?
GO-OUT Group and Workshop Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
1 siteCanada
Study dates
26 Feb 2018to 31 Aug 2020
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 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • older adults defined as age 65 years or older;
  • living independently in the community;
  • ambulatory defined as self-reported ability to walk at least one block (~50 m) continuously on a flat surface with or without a walking aid and without supervision;
  • self-reported difficulty walking in the outdoor community environment (this could include physical impairments or decreased confidence);
  • willingness to sign a liability waiver (required at three sites) or send a letter to their physician (required at one site) regarding clearance to exercise;
  • mental competency defined by a score of at least 18 out of 22 on the Mini-Mental State Exam telephone version;
  • available for a scheduled workshop and at least 5 of 10 weeks of the outdoor walking program; and
  • ability to speak and understand English

Who cannot join

  • physically active defined as self-reported participation in physical activities, such as walking and playing golf, 150 min per week;
  • currently receiving rehabilitation treatment, such as physical or occupational therapy, for goals related to walking (self-report);
  • at high falls risk defined by meeting one or more of the following American Geriatric Society criteria: (A) ≥2 falls in the last 12 months or presents with an acute fall; (B) cardiac, respiratory, peripheral vascular or other health conditions that would prevent safe and full participation in the interventions (self-report); (C) postural hypotension defined as a drop in systolic BP of >20 mm Hg or a drop in diastolic BP of >10 mm Hg taken after lying supine for 5 min and after standing for 2 min; (D) resting HR <45 or >100 beats per minute; and (E) severe limitation in visual acuity defined as self-reported difficulty reading the newspaper while wearing regular reading glasses or bifocals, or self-reported inability to distinguish a person's facial features from across a room while wearing glasses.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Knowledge to Action Lab, Department of Physical Therapy, University of Toronto

    Toronto, Ontario, M5G 1V7

Other trials in Canada

About this study

Official title: Getting Older Adults OUTdoors (GO-OUT): A Randomized Controlled Trial of a Theory-based, Task-oriented, Outdoor Walking Program for Older Adults With Difficulty Walking Outdoors

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 four evaluations: baseline, 3, 5.5 and 12 months later. The investigators will interview select participants at 6 and 12 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: In older adults with a limitation in outdoor community mobility:

  1. To estimate the extent to which a 1-day educational workshop and 10-week outdoor mobility program (GO-OUT intervention) compared to the workshop and weekly reminders improves outdoor walking activity (primary outcome) and secondary outcomes of physical activity, lifespace mobility, participation, HRQL, balance, leg strength, walking self-efficacy, walking speed, walking distance/endurance, and mood over 12 months.
  2. To explore participants' perceptions of intended and unintended consequences of the interventions, potent intervention components, mechanisms of effect, modifying influences of disability level, sex,neighborhood walkability, weather, car access, and study site, and recommendations for future program delivery models.

Approaches and Methods:Study Design: A 2-group mixed methods stratified randomized controlled trial following CONSORT criteria is proposed. Group allocation will be concealed and outcome evaluation blinded. The trial will be run at 4 sites (Edmonton, Winnipeg, Toronto, Montreal) to accrue a sufficient sample size, optimize the external validity of the results to urban centres variable in population size, weather conditions, and environmental barriers, and build capacity across 4 provinces to support potential implementation. Following a baseline assessment, eligible participants will be stratified by site, and randomly assigned to receive the 1-day educational workshop and 3-month outdoor mobility program (GO-OUT intervention) or the 1-day workshop plus weekly reminders. Follow-up evaluations will occur at 3, 5.5 and 12 months from baseline. A sub-sample of participants from the GO-OUT and workshop groups at each site will participate in face-to-face interviews at 6 and 12 months to explore their experiences. Interventions and assessments are designed to be implemented in 'good weather' months, to avoid the potential negative effect of season on the primary outcome of outdoor walking activity.

Being tested
GO-OUT Group, Workshop Group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GO-OUT GroupOther

    Following a baseline assessment, eligible participants will be stratified by site, and randomly assigned to receive the 1-day educational workshop and 3-month outdoor mobility program (GO-OUT intervention). Follow-up evaluations will occur at 3, 5.5 and 12 months from baseline.

  • Workshop GroupOther

    the 1-day workshop plus reminders. Follow-up evaluations will occur at 3, 5.5 and 12 months from baseline

Study groups in NCT03292510
Study groupRoleWhat they receive
GO-OUT GroupExperimentalParticipants attend 1-day walking workshop followed by a 3-month outdoor walking group intervention, twice weekly for 60-minutes. The same activities are completed during both sessions within the same week. Each session includes a 10-minute warm-up, a distance walk, practice of a specific outdoor walking skill, a distance walk, and a 10-minute cool down. The warm up and cool down include stretching, functional strengthening exercises and balance exercises taught during the workshop. The program incorporates the principles of task-specific training by emphasizing repetitive practice of progressively more difficult outdoor walking tasks. The outdoor walking program is conducted in one or more large park settings given the mental health benefits of exercising in a natural environment.
Receives: Other: GO-OUT Group
Workshop GroupActive comparatorThe 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.
Receives: Other: Workshop Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in average number of minutes per week spent walking outdoors

    The ActiGraph GT3X+ activity monitor (www.actigraphcorp.com/products/wgt3x-monitor/, ActiGraph, Pensacola, FL) and Qstarz BT-Q1000XT A-GPS Travel Recorder (http://www.qstarz.com/Products/GPS%20Products/BT-Q1000XT-F.htm) will be worn by each participant, clipped onto their waist band over the right hip during waking hours for 8 consecutive days at each evaluation timepoint (baseline, 3, 5.5, and 12 months).

    Measured: baseline, 3, 5.5, 12 months

Secondary outcomes (14)
  1. Change in the mean time per week spent walking outdoors on the Community Health Activities Model Program for Seniors (CHAMPS) Questionnaire

    The Community Health Activities Model Program for Seniors (CHAMPS) questionnaire is a measure of participation, physical activity and outdoor walking. Participants self-report time spent performing various social, leisure, and physical activities in a typical week during the last 4 weeks. Total time spent per week in outdoor walking will be determined.

    Measured: baseline, 3, 5.5, 12 months

  2. Change in the mean time per week spent in meaningful activity on the Community Health Activities Model Program for Seniors (CHAMPS) Questionnaire

    The Community Health Activities Model Program for Seniors (CHAMPS) questionnaire is a measure of participation, physical activity and outdoor walking. Participants self-report time spent performing various social, leisure, and physical activities in a typical week during the last 4 weeks. Total time spent per week in any activity will be determined.

    Measured: baseline, 3, 5.5, 12 months

  3. Change in the mean self-reported time per week spent in moderate- to vigorous-intensity physical activity on the Community Health Activities Model Program for Seniors (CHAMPS) Questionnaire

    The Community Health Activities Model Program for Seniors (CHAMPS) questionnaire is a measure of participation, physical activity and outdoor walking. Participants self-report time spent performing various social, leisure, and physical activities in a typical week during the last 4 weeks. Total time spent per week in moderate- to vigorous-intensity aerobic physical activity is determined.

    Measured: baseline, 3, 5.5, 12 months

  4. Change in the mean time per week spent in moderate- to vigorous-intensity physical activity directly measured using ActiGraph and GPS devices

    The ActiGraph GT3X+ activity monitor (www.actigraphcorp.com/products/wgt3x-monitor/, ActiGraph, Pensacola, FL) and Qstarz BT-Q1000XT A-GPS Travel Recorder (http://www.qstarz.com/Products/GPS%20Products/BT-Q1000XT-F.htm) will be worn by each participant, clipped onto their waist band over the right hip during waking hours for 8 consecutive days at each evaluation timepoint (baseline, 3, 5.5, and 12 months).

    Measured: baseline, 3, 5.5, 12 months

  5. Change in the mean score on the Life Space Assessment Questionnaire

    The Life Space Assessment Questionnaire is a measure of life space mobility. Total scores can range from 0 (totally bed bound) to 120 (travels out of the city every day without assistance). The score indicates level, degree of independence and frequency of attainment of mobility in five living spaces in the past four weeks: rooms in the house, the area outside the house, places in the neighbourhood, places outside the neighbourhood but within the city, and places outside the city.

    Measured: baseline, 3, 5.5, 12 months

  6. Change in the mean scores on the Patient Generated Index (PGI)

    For the PGI, participants select five most important areas of their life that are affected by their health, then rates the degree to which each area is affected from 0 (worst level imaginable) to 10 (best level of function possible).

    Measured: baseline, 3, 5.5, 12 months

  7. Change in the mean scores on the Research ANd Development-36 (RAND-36)

    The RAND-36 is a 36-item self-report measure of 8 health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain and general health perceptions. Total scores range from 0 to 100, where higher scores represent the most optimal health state.

    Measured: baseline, 3, 5.5, 12 months

  8. Change in the mean total score on the Mini Balance Evaluations Systems Test (Mini BESTest)

    The Mini BESTest is a measure of balance. Total scores can range from 0 to 28 points.

    Measured: baseline, 3, 5.5, 12 months

  9. Change in the mean number of sit-to-stands completed in 30 seconds in the 30-second Sit to Stand Test.

    The 30-second Sit to Stand Test is a measure of lower extremity strength. The minimum score is 0.

    Measured: baseline, 3, 5.5, 12 months

  10. Change in the mean score on the Ambulatory Self-Confidence Questionnaire

    The Ambulatory Self-Confidence Questionnaire is a 22-item questionnaire to measure self-efficacy to walk at home and/or in the community. The total score is the mean of item-level scores and can range from 0 to 10.

    Measured: baseline, 3, 5.5, 12 months

  11. Change in the mean walking speed on the 10m Walk Test, completed at a comfortable pace and a fast pace

    The 10m Walk Test is a measure of the participant's walking speed at a comfortable and fast pace. The participant uses his/her usual assistive device(s) and corrective eyewear.

    Measured: baseline, 3, 5.5, 12 months

  12. Change in the mean distance (in metres) walked on the 6-Minute Walk Test

    The 6-Minute Walk Test is a measure of walking endurance. Participants walk for 6 minutes unassisted using his/her usual mobility device. The distance walked in metres in 6 minutes is recorded.

    Measured: baseline, 3, 5.5, 12 months

  13. Change in resting heart rate

    Heart rate (HR) is taken at rest after sitting for at least 5 minutes with back supported and feet flat on the floor. HR is taken through manual palpation of the radial artery for 1 minute. Resting HR is part of the screening for participants prior to administering the 6-Minute Walk Test.

    Measured: baseline, 3, 5.5, 12 months

  14. Change in resting blood pressure

    Blood pressure (BP) is taken at rest after sitting for at least 5 minutes with back supported and feet flat on the floor. BP is taken using a manual or automated documented. Resting BP is part of the screening for participants prior to administering the 6-Minute Walk Test.

    Measured: baseline, 3, 5.5, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2017
  2. Study start26 Feb 2018
  3. Primary completion31 Aug 2020
  4. Study completion31 Aug 2020

Resources

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
Model description
Experimental: GO-OUT program 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 10 weeks. Intervention: Other: GO-OUT program Active Comparator: Task-oriented outdoor walking workshop An outdoor walking workshop with stations to learn various outdoor walking skills and information. Intervention: Other: Task-oriented outdoor walking workshop
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03292510
Sponsor's protocol ID
G-16-00013978
Status last verified
Oct 2023
First submitted
20 Sep 2017
Last updated
4 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Su TT, Barclay R, Moineddin R, Salbach NM. The impact of outdoor walking interventions on frailty among older adults with mobility limitations: Findings from the Getting Older Adults Outdoors (GO-OUT) study. PLoS One. 2025 Sep 12;20(9):e0323923. doi: 10.1371/journal.pone.0323923. eCollection 2025.

    PubMed 40938877
  • Su TT, Barclay R, Moineddin R, Salbach NM. Examining dose-response of an outdoor walk group program in the Getting Older Adults Outdoors (GO-OUT) trial. PLoS One. 2025 Mar 13;20(3):e0309933. doi: 10.1371/journal.pone.0309933. eCollection 2025.

    PubMed 40080515
  • Kokorelias KM, Ripat J, Barclay R, Jones CA, Mayo NE, Grant T, Scodras S, Alsbury-Nealy K, Ryder-Burbidge C, Salbach NM. A park-based group mobility program for older adults with difficulty walking outdoors: a qualitative process evaluation of the Getting Older Adults Outdoors (GO-OUT) randomized controlled trial. BMC Geriatr. 2025 Jan 8;25(1):16. doi: 10.1186/s12877-024-05611-z.

    PubMed 39780066
  • Salbach NM, Mayo NE, Webber SC, Jones CA, Lix LM, Ripat J, Grant T, van Ineveld C, Chilibeck PD, Romanescu RG, Scott S, Barclay R. Short-term effects of a park-based group mobility program on increasing outdoor walking in older adults with difficulty walking outdoors: the Getting Older Adults Outdoors (GO-OUT) randomized controlled trial. BMC Geriatr. 2024 Sep 6;24(1):740. doi: 10.1186/s12877-024-05331-4.

    PubMed 39243012
  • Barclay R, Webber SC, Hahn F, Jones CA, Mayo NE, Sivakumaran S, Liu Y, Chilibeck PD, Salbach NM. A park-based group mobility program for older adults with difficulty walking outdoors: a quantitative process evaluation of the Getting Older Adults Outdoors (GO-OUT) randomized controlled trial. BMC Geriatr. 2023 Dec 11;23(1):833. doi: 10.1186/s12877-023-04524-7.

    PubMed 38082248
  • Salbach NM, Barclay R, Webber SC, Jones CA, Mayo NE, Lix LM, Ripat J, Grant T, van Ineveld C, Chilibeck PD. A theory-based, task-oriented, outdoor walking programme for older adults with difficulty walking outdoors: protocol for the Getting Older Adults Outdoors (GO-OUT) randomised controlled trial. BMJ Open. 2019 Apr 20;9(4):e029393. doi: 10.1136/bmjopen-2019-029393.

    PubMed 31005945

Questions about this trial

What is this clinical trial studying?

A study testing GO-OUT Group and Workshop Group in people with Older Adults With Decreased Outdoor Walking Ability, run by University of Toronto 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 8 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 4 Oct 2023. 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 average number of minutes per week spent walking outdoors (time frame: baseline, 3, 5.5, 12 months). 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 NCT03292510, which also lists 6 linked publications.

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 4 Oct 2023.

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