Getting Older Adults OUTdoors (GO-OUT)

October 2, 2023 updated by: Dr. Nancy Salbach, University of Toronto

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1V7
        • Knowledge to Action Lab, Department of Physical Therapy, University of Toronto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 100 years (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. older adults defined as age 65 years or older;
  2. living independently in the community;
  3. 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;
  4. self-reported difficulty walking in the outdoor community environment (this could include physical impairments or decreased confidence);
  5. 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;
  6. mental competency defined by a score of at least 18 out of 22 on the Mini-Mental State Exam telephone version;
  7. available for a scheduled workshop and at least 5 of 10 weeks of the outdoor walking program; and
  8. ability to speak and understand English

Exclusion Criteria:

  1. physically active defined as self-reported participation in physical activities, such as walking and playing golf, 150 min per week;
  2. currently receiving rehabilitation treatment, such as physical or occupational therapy, for goals related to walking (self-report);
  3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GO-OUT Group
Participants 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.
Other: GO-OUT Group
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.
Active Comparator: Workshop Group
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.
Other: Workshop Group
the 1-day workshop plus reminders. Follow-up evaluations will occur at 3, 5.5 and 12 months from baseline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in average number of minutes per week spent walking outdoors
Time Frame: baseline, 3, 5.5, 12 months
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).
baseline, 3, 5.5, 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the mean time per week spent walking outdoors on the Community Health Activities Model Program for Seniors (CHAMPS) Questionnaire
Time Frame: baseline, 3, 5.5, 12 months
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.
baseline, 3, 5.5, 12 months
Change in the mean time per week spent in meaningful activity on the Community Health Activities Model Program for Seniors (CHAMPS) Questionnaire
Time Frame: baseline, 3, 5.5, 12 months
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.
baseline, 3, 5.5, 12 months
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
Time Frame: baseline, 3, 5.5, 12 months
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.
baseline, 3, 5.5, 12 months
Change in the mean time per week spent in moderate- to vigorous-intensity physical activity directly measured using ActiGraph and GPS devices
Time Frame: baseline, 3, 5.5, 12 months
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).
baseline, 3, 5.5, 12 months
Change in the mean score on the Life Space Assessment Questionnaire
Time Frame: baseline, 3, 5.5, 12 months
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.
baseline, 3, 5.5, 12 months
Change in the mean scores on the Patient Generated Index (PGI)
Time Frame: baseline, 3, 5.5, 12 months
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).
baseline, 3, 5.5, 12 months
Change in the mean scores on the Research ANd Development-36 (RAND-36)
Time Frame: baseline, 3, 5.5, 12 months
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.
baseline, 3, 5.5, 12 months
Change in the mean total score on the Mini Balance Evaluations Systems Test (Mini BESTest)
Time Frame: baseline, 3, 5.5, 12 months
The Mini BESTest is a measure of balance. Total scores can range from 0 to 28 points.
baseline, 3, 5.5, 12 months
Change in the mean number of sit-to-stands completed in 30 seconds in the 30-second Sit to Stand Test.
Time Frame: baseline, 3, 5.5, 12 months
The 30-second Sit to Stand Test is a measure of lower extremity strength. The minimum score is 0.
baseline, 3, 5.5, 12 months
Change in the mean score on the Ambulatory Self-Confidence Questionnaire
Time Frame: baseline, 3, 5.5, 12 months
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.
baseline, 3, 5.5, 12 months
Change in the mean walking speed on the 10m Walk Test, completed at a comfortable pace and a fast pace
Time Frame: baseline, 3, 5.5, 12 months
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.
baseline, 3, 5.5, 12 months
Change in the mean distance (in metres) walked on the 6-Minute Walk Test
Time Frame: baseline, 3, 5.5, 12 months
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.
baseline, 3, 5.5, 12 months
Change in resting heart rate
Time Frame: baseline, 3, 5.5, 12 months
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.
baseline, 3, 5.5, 12 months
Change in resting blood pressure
Time Frame: baseline, 3, 5.5, 12 months
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.
baseline, 3, 5.5, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Manitoba
McGill University
University of Alberta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nancy Salbach, PhD, Associate professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • G-16-00013978

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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