Chiropractor Delivered Virtual Intervention After Vertebral frActure (VIVA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Feasibility of Chiropractic Delivery
研究概览
简要总结
This study will determine feasibility of a chiropractor delivered virtual intervention for individuals following osteoporotic vertebral fracture.
This pilot trial will have two parallel groups with a 1:1 ratio. Participants will be randomized to: 1) immediate receipt; or 2) waitlist usual care control and delayed receipt of VIVA 10 weeks post-randomization.
VIVA is an intervention for people with vertebral fractures that covers four areas: pain management, safe movement, exercise, and nutrition. It includes print and video resources, and a framework for goal setting, selecting exercises, and teaching body mechanics.
A chiropractor (DC) completes a virtual assessment and then leads twelve 1:1 virtual sessions (via Zoom) over eight weeks. Sessions start with brief education on a topic (e.g., safe movement, pain management, exercise, nutrition), followed by training and modeling of exercise and safe movement strategies, then goal setting, and action planning.
This trial will be considered feasible if a) we recruit 14 people in eight months; b) 80% of participants complete the trial; and c) exercise adherence is 75%.
详细描述
Spine fractures are the most common fracture due to osteoporosis. They can happen because of falls or activities of daily life like bending and lifting. Fractures of the spine can result in pain, which can last for a long time. Spine fractures can affect breathing, appetite, digestion, and mobility, and can restrict or modify an individuals' work or daily activities.
There are no standard rehabilitation programs after spine fracture, and patients often must pay out of pocket for rehabilitation. Rehabilitation can be hard to access (especially in rural or remote locations) and it can be difficult to find providers with training and expertise to treat spine fractures.
Our team includes Osteoporosis Canada, patients, health care professionals, and researchers from multiple provinces. We reviewed research, consulted patients and healthcare providers to understand their experiences with spine fracture rehabilitation to develop a Toolkit for a virtual rehabilitation program for people with spine fracture, called VIVA.
VIVA is an intervention for people with vertebral fractures that covers four areas: pain management, safe movement, exercise, and nutrition. It includes print and video resources, and a framework for goal setting, selecting exercises, and teaching body mechanics. We used the Behavior Change Wheel method to select four implementation strategies: education on pain management, safe movement, exercise, and nutrition; modeling of and training on exercises, safe movement, and pain management strategies; and enablement, such as goal setting, action planning, and self-monitoring.
Participants receive a technology consultation 1-2 weeks prior to baseline assessment, and receive intervention in week one (immediately post-randomization) or in week ten (waitlist control). A provider completes a virtual assessment, and then leads 1:1 once-weekly virtual sessions (via Zoom) over eight weeks. Sessions start with brief education on a topic (e.g., safe movement, pain management, exercise, nutrition), followed by training and modeling of exercise and safe movement strategies, then goal setting, and action planning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blind to group allocation. Participants will not be blind to group allocation because they will know what group they are assigned to.
The waitlist control was chosen based on input from persons with lived experience, who indicated that participants may be more willing to participate if there was a wait list control rather than receiving no intervention.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of 50 (men or post-menopausal women)
- •Have had a vertebral fracture in the past two years
- •Willing to participate in twelve (12) virtual rehabilitation sessions for 10 weeks
- •Have access to internet and a smart device with a camera and microphone
排除标准
- •Cauda equina syndrome or spinal cord injury
- •Had a traumatic fracture (i.e., car accident)
- •An active infection
- •Active inflammatory arthritis with a flare up within the past two years
- •An inability to follow two-step commands or understand instructions and are without a caregiver to support participation
- •Been participating in a similar rehabilitation program for vertebral fractures delivered by a physical therapist, exercise physiologist or kinesiologist and includes exercise
- •Any surgeries planned or health problems that might cause their health to change significantly in the next 3 months
结局指标
主要结局
Feasibility of Chiropractic Delivery
时间窗: We will consider ≥80% retention at 20 weeks acceptable. Adherence will be defined as ≥2 sessions per week of exercise at 20 weeks
This trial will be considered feasible if a) we recruit 14 people in eight months; b) 80% of participants complete the trial; and c) exercise adherence is 75%.
次要结局
- Participant experience(At completion of 10 weeks.)
- Pain and Quality of Life(Will be measured at weeks 10/20 (effectiveness) and 20 weeks (sustainability, immediate group only)
- Health-Related Quality of life(Will be measured at weeks 10/20 (effectiveness) and 20 weeks (sustainability, immediate group only)
- Physical Performance - Balance(Physical performance will be measured at weeks 10/20 (effectiveness) and 20 (sustainability, immediate group only).)
- Adherence to diet recommendations(Measured at 20 weeks, immediate group only)
- Physical Performance - Sit to Stand Performance(Physical performance will be measured at weeks 10/20 (effectiveness) and 20 (sustainability, immediate group only))
- Adverse events(On-going, disclosed during intervention sessions, or at assessment milestones (week 10 and 20).)