Wearable Technology for Promoting Physical Activity in Middle-Aged Adults With Chronic Musculoskeletal Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Visual Analogue Scale (VAS) of Quality of Life
研究概览
简要总结
This protocol is for a pragmatic mixed methods randomized parallel-group exploratory feasibility trial to examine all facets of a proposed future phase III trial on the use of wearable device to increase physical activity and possibly reduce pain amongst middle-aged people with musculoskeletal (MSK) chronic pain. The feasibility study is intended to answer the following research questions:
Question 1 Evaluate the acceptability of all aspect of the study design of wearable devices as an intervention to increase physical activity in middle-aged adults with musculoskeletal chronic pain.
Question 2: Is it feasible and acceptable to use wearable devices as an intervention to increase physical activity in middle-aged adults with musculoskeletal chronic pain? Question 3: How can using wearable device promote physical activity effectively in middle-aged adults with musculoskeletal chronic pain?
Participants will be recruited from a National Health Service (NHS) pain clinic and randomised on a ratio1:3 into control group (standard care) and intervention group (standard care combined with wearable device). The feasibility study will last for 18 months, participants involvement will be for 24 weeks. Patients in both groups can participate in any physical activity, including planned, structured, and repetitive bodily movement exercise or occupational and recreational PA. Qualitative semi-structured interview will be conducted at baseline and week-12, while outcome measures will be conducted at baseline, 4-week, 8-week,12-week, and 24-week for all participants to examine their pain, physical activity, and their responses to the trial. Qualitative interview will be conducted for stakeholders which include clinicians and service managers after all patient data has been collected. This study has the potential to make an original contribution to provide key data on the feasibility, acceptability, and effectiveness of using wearable technology to support physical activity intervention for middle-aged adults with musculoskeletal chromic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of any gender identity 40-65 years old.
- •Willingness to participate in the trial.
- •Able to understand and speak sufficient English to engage during interviews.
- •They have self-reported persistent or recurrent musculoskeletal pain for three months or longer.
- •Participants will be receiving treatment for musculoskeletal chronic pain.
排除标准
- •Palliative patient.
- •Patients of any gender identity younger than 40-year-old or older than 65-year-old.
- •Patients that are dependent on alcohol or drugs.
- •Involvement with other ongoing studies.
- •Patients unable to complete the questionnaires as judged by the researcher.
结局指标
主要结局
Change in Visual Analogue Scale (VAS) of Quality of Life
时间窗: Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)
Change in Numerical Pain Rating Scale (NPRS)
时间窗: Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)
Change in Brief Pain Inventory
时间窗: Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)
Change in Visual Analogue Scale (VAS) of pain
时间窗: Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)
Change in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L)
时间窗: Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)
Change in Pain Catastrophising Scale
时间窗: Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)
Change in The International Physical Activity Questionnaire (IPAQ)
时间窗: Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)
Change in Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
时间窗: Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)
Change in Chronic Pain Coping Inventory (CPCI)
时间窗: Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)
次要结局
未报告次要终点
研究者
John Hughes
Associate Professor
University of West London