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Getting Older Adults OUT-of -Doors (GO-OUT)

2017年5月16日 更新者:University of Manitoba

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

9

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Manitoba
      • Winnipeg、Manitoba、カナダ、R3E 0W3
        • University of Manitoba College of Rehabilitation Sciences

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

65年歳以上 (高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
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.
アクティブコンパレータ:Task-oriented outdoor walking workshop
An outdoor walking workshop with stations to learn various outdoor walking skills and information.
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Outdoor walking activity - CHAMPS questionnaire
時間枠: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.
baseline, 3,6 months
Change in Outdoor walking activity -GPS data
時間枠: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.
baseline, 3,6 months
Change in Outdoor walking activity -Accelerometry
時間枠: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.
baseline, 3,6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Aerobic capacity (Six minute walk test)
時間枠:baseline, 3,6 months
Six minute walk test - distance walked in 6 minutes.
baseline, 3,6 months
Change in Walking competency (Berg Balance scale)
時間枠: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.
baseline, 3,6 months
Change in Mood (Geriatric depression scale)
時間枠:baseline, 3,6 months
Geriatric depression scale. If a participant scores >9, they will not be excluded, but the family physician will be notified.
baseline, 3,6 months
Change in Health Related Quality of life (The Rand-36)
時間枠:baseline, 3,6 months
The Rand-36, self reported mental health and physical function.
baseline, 3,6 months
Change in Participation (CHAMPS)
時間枠: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.
baseline, 3,6 months

その他の成果指標

結果測定
メジャーの説明
時間枠
Neighbourhood walkability (Neighbourhood Environment Walkability Scale (NEWS)
時間枠: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.
baseline

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Nancy Salbach, PhD、University of Toronto
  • 主任研究者:Ruth Barclay, PhD、University of Manitoba

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2015年2月1日

一次修了 (実際)

2015年11月1日

研究の完了 (実際)

2015年11月1日

試験登録日

最初に提出

2015年1月7日

QC基準を満たした最初の提出物

2015年1月14日

最初の投稿 (見積もり)

2015年1月15日

学習記録の更新

投稿された最後の更新 (実際)

2017年5月17日

QC基準を満たした最後の更新が送信されました

2017年5月16日

最終確認日

2016年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • H2014:391

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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