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临床试验/NCT03929393
NCT03929393已完成不适用

Mindful Movement for Physical Activity and Wellbeing in Older Adults- A Community Based Randomized Hybrid Effectiveness-Implementation Study

University of Minnesota5 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2019年7月17日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
176
试验地点
5
主要终点
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Physical inactivity has reached pandemic proportions and is associated with increased morbidity, mortality, and healthcare costs. Of particular concern is that most middle to older age adults fall far short of recommendations for health enhancing physical activities. This research takes a novel approach to tackling this problem by combining mindfulness with behavioral strategies in a unique 'Mindful Movement' program offered collaboratively with the YMCA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •≥ 50 years of age
  • •Accelerometer wear time ≥10 hours on at least 4 days in a 7 consecutive day period between baselines
  • •Self-report of <140 minutes of MVPA per week in 3 months prior to baseline AND accelerometer recorded <100 minutes of MVPA between baselines
  • •Mini-Mental State score ≥ 24 if indicated
  • •Independent self-ambulation
  • •Provides consent and is willing to participate in data collection activities

排除标准

  • •Pregnancy
  • •Unwilling or unable to participate in study activities
  • •Current or upcoming participation in educational programs similar to those under study
  • •Medical restrictions to increasing Moderate Vigorous Physical Activity (MVPA)
  • •Terminal illness
  • •Contraindications to mindfulness practice

研究组 & 干预措施

Mindful Movement

Experimental

8, 90-minute, in-person, group sessions over 8 weeks

干预措施: Mindful Movement (Behavioral)

Keys to Health & Wellbeing

Active Comparator

8, 90-minute, in-person, group sessions over 8 weeks

干预措施: Keys to Health & Wellbeing (Other)

结局指标

主要结局

Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts

时间窗: Change score: 9 weeks - baseline

Minutes/week spent in ≥10-min bouts of MVPA

Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts

时间窗: Baseline

Minutes/week spent in ≥10-min bouts of MVPA

次要结局

  • Working Alliance Inventory (WAI)(9 weeks)
  • Quality of Life - EuroQol VAS(Change score: 52 weeks - baseline)
  • Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale(Change score: 52 weeks - baseline)
  • Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts(Change score: 52 weeks - baseline)
  • Average Daily Step Count(Change score: 52 weeks - baseline)
  • Quality of Life - Euroqol 5D (EQ5D)(Change score: 52 weeks - baseline)
  • Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale(Change score: 52 weeks - baseline)
  • Social Connectedness(Change score: 52 weeks - baseline)
  • Covid -19 Impact on Physical Activity(52 weeks)
  • Mindfulness - Frieberg Mindfulness Inventory (FMI)(Change score: 52 weeks - baseline)
  • Wellbeing-8-item Flourishing Scale(Change score: 52 weeks - baseline)
  • Physical Activity-International Physical Activity Questionnaire (IPAQ)(Change score: 52 weeks - baseline)
  • Number of Participants Completing Qualitative Assessment of Barriers to Intervention(9 weeks)
  • Total Moderate-Vigorous Physical Activity (MVPA)(Change score: 52 weeks - baseline)
  • Sedentary Activity(Change score: 52 weeks - baseline)
  • Frequency of Home Practice(52 weeks)
  • Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale(Change score: 52 weeks - baseline)
  • Mindfulness - Mindful Attention Awareness Scale (MAAS)(Change score: 52 weeks - baseline)
  • Social Assuredness(Change score: 52 weeks - baseline)
  • Satisfaction With Intervention(52 weeks)
  • Number of Participants Completing Qualitative Assessment of Facilitators to Intervention(9 weeks)
  • Pain-11 Box Numerical Rating Scale(Change score: 52 weeks - baseline)
  • Telehealth Usability Questionnaire(9 weeks)
  • Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts(Change score: 26 weeks - baseline)
  • Sedentary Activity(Change score: 9 weeks - baseline)
  • Total Moderate-Vigorous Physical Activity (MVPA)(Baseline)
  • Total Moderate-Vigorous Physical Activity (MVPA)(Change score: 9 weeks - baseline)
  • Total Moderate-Vigorous Physical Activity (MVPA)(Change score: 26 weeks - baseline)
  • Sedentary Activity(Baseline)
  • Sedentary Activity(Change score: 26 weeks - baseline)
  • Average Daily Step Count(Baseline)
  • Average Daily Step Count(Change score: 9 weeks - baseline)
  • Average Daily Step Count(Change score: 26 weeks - baseline)
  • Quality of Life - Euroqol 5D (EQ5D)(Baseline)
  • Quality of Life - Euroqol 5D (EQ5D)(Change score: 9 weeks - baseline)
  • Quality of Life - Euroqol 5D (EQ5D)(Change score: 26 weeks - baseline)
  • Quality of Life - EuroQol VAS(Baseline)
  • Quality of Life - EuroQol VAS(Change score: 9 weeks - baseline)
  • Wellbeing-8-item Flourishing Scale(Change score: 9 weeks - baseline)
  • Quality of Life - EuroQol VAS(Change score: 26 weeks - baseline)
  • Frequency of Home Practice(9 weeks)
  • Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale(Baseline)
  • Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale(Change score: 9 weeks - baseline)
  • Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale(Change score: 26 weeks - baseline)
  • Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale(Baseline)
  • Mindfulness - Frieberg Mindfulness Inventory (FMI)(Change score: 9 weeks - baseline)
  • Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale(Change score: 9 weeks - baseline)
  • Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale(Change score: 26 weeks - baseline)
  • Social Assuredness(Change score: 9 weeks - baseline)
  • Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale(Baseline)
  • Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale(Change score: 9 weeks - baseline)
  • Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale(Change score: 26 weeks - baseline)
  • Mindfulness - Mindful Attention Awareness Scale (MAAS)(Baseline)
  • Mindfulness - Mindful Attention Awareness Scale (MAAS)(Change score: 9 weeks - baseline)
  • Mindfulness - Mindful Attention Awareness Scale (MAAS)(Change score: 26 weeks - baseline)
  • Mindfulness - Frieberg Mindfulness Inventory (FMI)(Baseline)
  • Mindfulness - Frieberg Mindfulness Inventory (FMI)(Change score: 26 weeks - baseline)
  • Wellbeing-8-item Flourishing Scale(Baseline)
  • Wellbeing-8-item Flourishing Scale(Change score: 26 weeks - baseline)
  • Social Connectedness(Baseline)
  • Social Connectedness(Change score: 9 weeks - baseline)
  • Social Connectedness(Change score: 26 weeks - baseline)
  • Social Assuredness(Baseline)
  • Social Assuredness(Change score: 26 weeks - baseline)
  • Physical Activity-International Physical Activity Questionnaire (IPAQ)(Baseline)
  • Physical Activity-International Physical Activity Questionnaire (IPAQ)(Change score: 9 weeks - baseline)
  • Physical Activity-International Physical Activity Questionnaire (IPAQ)(Change score: 26 weeks - baseline)
  • Satisfaction With Intervention(9 weeks)
  • Satisfaction With Intervention(26 weeks)
  • Frequency of Home Practice(26 weeks)
  • Pain-11 Box Numerical Rating Scale(Baseline)
  • Pain-11 Box Numerical Rating Scale(Change score: 9 weeks - baseline)
  • Pain-11 Box Numerical Rating Scale(Change score: 26 weeks - baseline)
  • Covid -19 Impact on Physical Activity(Baseline)
  • Covid -19 Impact on Physical Activity(9 weeks)
  • Covid -19 Impact on Physical Activity(26 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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