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临床试验/NCT03016728
NCT03016728已完成不适用

Exploring the Feasibility, Safety, and Potential Benefits of a 12-week Home-based Physical Activity Intervention

University of Ottawa2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2017年9月11日最近更新:
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
17
试验地点
2
主要终点
Retention Rates

研究概览

简要总结

More adolescents and young adults are surviving cancer than ever before. Many endure negative effects related to their cancer and its treatment, which reduces their quality of life and functioning. Physical activity is one strategy that has been shown to promote quality of life amongst cancer survivors. However, very little research has focused on adolescent and young adult cancer survivors. Therefore, the purpose of this pilot randomized controlled trial is to explore the feasibility, safety, and potential benefits of a 12-week home-based physical activity intervention in adolescent and young adult cancer survivors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
15 Years 至 44 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Physical Activity

Experimental

Participants in the experimental arm (i.e., physical activity) will be asked to complete the 12-week home-based physical activity program and to complete all study assessments.

干预措施: Physical Activity (Behavioral)

Wait-List Control

No Intervention

Participants in the no intervention arm (i.e., wait-list control) will be asked to maintain their usual lifestyle activities and to complete all study assessments. Participants in this arm will be provided with the 12-week home-based physical activity program in the exact same way as participants in the experimental arm (i.e., physical activity) at the end of the study.

结局指标

主要结局

Retention Rates

时间窗: Through study completion, an average of 12-24 weeks

The number of participants completing the intervention and all scheduled assessments.

Recruitment Rates

时间窗: Through study completion, an average of 12-24 weeks

The number of eligible participants who enrol in the study out of the number who are referred.

Adherence Rates

时间窗: Through study completion, an average of 12-24 weeks

The number of physical activity sessions engaged in out of the total recommended as part of the intervention.

Number of Participants with Adverse Events

时间窗: Through study completion, an average of 12-24 weeks

The number of participants reporting or presenting adverse events (e.g., injury) that occurs as a result of participating in the physical activity intervention and/or its assessments.

次要结局

  • Physical Activity Behaviour: Daily Physical Activity Logbook(Through study completion, an average of 12-24 weeks)
  • Resting Heart Rate(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
  • Muscular Endurance: 30-Second Sit to Stand Test (Rikli & Jones, 2001)(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
  • Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24))
  • Global Self-Esteem: Rosenberg Global Self-Esteem Scale (Rosenberg, 1965)(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
  • Body Image: Multidimensional Body-Self Relations Questionnaire Appearance Evaluation and Body Areas Satisfaction scales (Cash, 2000)(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
  • Physical Activity Behaviour: 7-Day Accelerometer Wear (Objective Physical Activity Behaviour)(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24))
  • Blood Pressure(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
  • Body Composition: Body Mass Index(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
  • Aerobic Capacity: 6-Minute Walk Test (CSEP, 2013; Irwin, 2012)(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
  • Self-Efficacy: Single-Item Version of the Exercise Self-Efficacy Scale (McAuley, 1993)(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
  • Musculoskeletal Strength: Combined Grip Strength using a Handheld Dynamometer (CSEP, 2013; Irwin, 2012)(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
  • Posttraumatic Growth: Posttraumatic Growth Inventory (Tedeschi & Calhoun, 1996)(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
  • Physical Competence and Physical Self-Esteem: Physical Self-Description Questionnaire Short-Form Appearance, Strength, Endurance, Body Fat, and Physical Self-Esteem scales (Marsh, Martin, & Jackson, 2010)(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
  • Quality of Life: Medical Outcomes Study 36-Item Short-Form Health Survey (Ware & Sherbourne, 1992)(Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12))
  • Participants Experiences: Qualitative Interviews(Baseline (week 0), post-intervention (week 12))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Brunet

PhD, Assistant Professor

University of Ottawa

研究点 (2)

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