Improving Health Self-Management Using Walking Biobehavioral Intervention for People With Dysvascular Lower Limb Amputation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Physical Activity
研究概览
简要总结
The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.
详细描述
Sedentary lifestyles and high levels of disability are relevant public and personal health issues resulting from the chronic comorbid condition of dysvascular lower limb amputation. This study examines the use of an evidence-based walking biobehavioral intervention to increase physical activity after dysvascular amputation. The proposed intervention leverages successes in conventional prosthetic rehabilitation, while addressing the complex health conditions and chronic sedentary behaviors that underlie dysvascular amputation, with the ultimate goal of improved physical activity self-management to minimize disability.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Within the age range of 50-85 years
- •Confirmed diagnosis of Type II Diabetes Mellitus (DM) and/or Peripheral Artery Disease (PAD)
- •Transtibial, knee disarticulation, or transfemoral lower-limb amputation (LLA) (or re-amputation) within the past 12 months
- •Participant goal of household walking or better using a prosthesis
排除标准
- •Trauma or cancer-related etiology of the LLA
- •Decisionally challenged individuals (MMSE score below 24)
- •Prisoners
- •Active cancer treatment
- •Recent stroke (within 2 years)
- •Clinical discretion of principal investigator to exclude patients who are determined to be unsafe and/or inappropriate to participate in the described intervention.
研究组 & 干预措施
Walking Biobehavioral Intervention (EXP)
The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.
干预措施: Walking Biobehavioral Intervention (Behavioral)
Attention Control (CTL)
The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).
干预措施: Attention Control (Other)
结局指标
主要结局
Physical Activity
时间窗: 3 months and 6 months
The number of steps per day measured with ActivPAL, assessed for 10 days at 3 months and 6 months. 10-day average at 3 months and at 6 months reported.
次要结局
- Prosthesis Evaluation Questionnaire - Mobility Score(Day 0, 3 months, 6 months and 12 months)
- World Health Organization-Disability Assessment Schedule 2.0(Day 0, 3 months, 6 months and 12 months)
- Self-Efficacy for Managing Chronic Disease(Day 0, 3 months, 6 months and 12 months)
- Patient Reported Outcomes Measurement Information System: Self-Efficacy for Managing Symptoms(Day 0, 3 months, 6 months and 12 months)
- Patient Reported Outcomes Measurement Information System: Self-Efficacy for Managing Daily Activities(Day 0, 3 months, 6 months and 12 months)
- Patient Reported Outcomes Measurement Information System: Ability to Participate in Social Roles and Activities(Day 0, 3 months, 6 months and 12 months)
- Timed Up-and-Go Test(Day 0, 3 months, 6 months and 12 months)