Clinical trial NCT03292510: Getting Older Adults OUTdoors (GO-OUT)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults With Decreased Outdoor Walking Ability
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: University of Manitoba
name: University of Alberta
name: McGill University
First posted: 2017-09-25
Enrollment: 190
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in average number of minutes per week spent walking outdoors
timeFrame: baseline, 3, 5.5, 12 months
Secondary outcomes:
measure: Change in the mean time per week spent walking outdoors on the Community Health Activities Model Program for Seniors (CHAMPS) Questionnaire
timeFrame: baseline, 3, 5.5, 12 months
measure: Change in the mean time per week spent in meaningful activity on the Community Health Activities Model Program for Seniors (CHAMPS) Questionnaire
timeFrame: baseline, 3, 5.5, 12 months
measure: 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
timeFrame: baseline, 3, 5.5, 12 months
measure: Change in the mean time per week spent in moderate- to vigorous-intensity physical activity directly measured using ActiGraph and GPS devices
timeFrame: baseline, 3, 5.5, 12 months
measure: Change in the mean score on the Life Space Assessment Questionnaire
timeFrame: baseline, 3, 5.5, 12 months
measure: Change in the mean scores on the Patient Generated Index (PGI)
timeFrame: baseline, 3, 5.5, 12 months
measure: Change in the mean scores on the Research ANd Development-36 (RAND-36)
timeFrame: baseline, 3, 5.5, 12 months
measure: Change in the mean total score on the Mini Balance Evaluations Systems Test (Mini BESTest)
timeFrame: baseline, 3, 5.5, 12 months
measure: Change in the mean number of sit-to-stands completed in 30 seconds in the 30-second Sit to Stand Test.
timeFrame: baseline, 3, 5.5, 12 months
measure: Change in the mean score on the Ambulatory Self-Confidence Questionnaire
timeFrame: baseline, 3, 5.5, 12 months
measure: Change in the mean walking speed on the 10m Walk Test, completed at a comfortable pace and a fast pace
timeFrame: baseline, 3, 5.5, 12 months
measure: Change in the mean distance (in metres) walked on the 6-Minute Walk Test
timeFrame: baseline, 3, 5.5, 12 months
measure: Change in resting heart rate
timeFrame: baseline, 3, 5.5, 12 months
measure: Change in resting blood pressure
timeFrame: baseline, 3, 5.5, 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Knowledge to Action Lab, Department of Physical Therapy, University of Toronto
state: Ontario
Study officials:
affiliation: Associate Professor
name: Nancy Salbach, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.