Getting Older Adults OUT-of -Doors (GO-OUT)
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|ClinicalTrials.gov Identifier: NCT02339467|
Recruitment Status : Completed
First Posted : January 15, 2015
Last Update Posted : May 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Older Adults With Decreased Outdoor Walking Ability||Other: GO-OUT program Other: Task-oriented outdoor walking workshop||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Getting Older Adults OUT-of-doors (GO-OUT): A Randomized Controlled Trial of a Community-based Outdoor Walking Program|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
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 3 months.
Other: GO-OUT program
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.
Active Comparator: Task-oriented outdoor walking workshop
An outdoor walking workshop with stations to learn various outdoor walking skills and information.
Other: Task-oriented outdoor walking workshop
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.
- 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.
- Change in Aerobic capacity (Six minute walk test) [ Time Frame: baseline, 3,6 months ]Six minute walk test - distance walked in 6 minutes.
- Change in Walking competency (Berg Balance scale) [ Time Frame: baseline, 3,6 months ]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.
- Change in Mood (Geriatric depression scale) [ Time Frame: baseline, 3,6 months ]Geriatric depression scale. If a participant scores >9, they will not be excluded, but the family physician will be notified.
- Change in Health Related Quality of life (The Rand-36) [ Time Frame: baseline, 3,6 months ]The Rand-36, self reported mental health and physical function.
- Change in Participation (CHAMPS) [ Time Frame: baseline, 3,6 months ]Time in minutes per week spent performing all 40 social, leisure and physical activities described in the CHAMPS will be used in the analysis.
- Neighbourhood walkability (Neighbourhood Environment Walkability Scale (NEWS) [ Time Frame: baseline ]67-item self-report Neighbourhood Environment Walkability Scale (NEWS). Socio-economic characteristics of neighbourhoods in which participants reside will also be collected, using neighbourhood census data. NEWS is the most commonly internationally used self-report measure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02339467
|University of Manitoba College of Rehabilitation Sciences|
|Winnipeg, Manitoba, Canada, R3E 0W3|
|Principal Investigator:||Ruth Barclay, PhD||University of Manitoba|
|Principal Investigator:||Nancy Salbach, PhD||University of Toronto|