Personalised Activity Plan for BREAKing UP Sitting Time in Patients With Peripheral Arterial Disease and Intermittent Claudication (The BREAK UP Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- To investigate overall changes in sitting time
研究概览
简要总结
Intermittent claudication is the most common manifestation of peripheral arterial disease, a common cardiovascular disease that causes blocked blood vessels (arteries) in the leg. Symptoms consist of persistent pain in one or both legs during exercise that is relieved with rest. Evidence suggests that high levels of uninterrupted sitting and sedentary behaviour are associated with cardiovascular disease risk, mortality and all-cause mortality. One of the main goals for treating people with intermittent claudication, is increased participation in physical activity. Supervised Exercise Programmes are recommended however these are not well tolerated and compliance is low. Alternative exercise, including short bouts of physical activity to break up sedentary time, has been suggested to help improve physical function.
This study will investigate whether alternative exercise, in the form of breaking up prolonged sitting time, will improve physical function in patients with intermittent claudication.
Patients will be screened during their routine clinic appointment at Glenfield Hospital. All other study activity will take place at the patients home.
Activity monitors will be worn for up to 8 days at baseline and follow-up, measuring step count and time, inactivity, activity time and intensity, and sleep duration. Participants will also be expected to wear activity monitors for the duration of the 8-week intervention to measure steps. Participants will be in the study for up to 18 weeks in total.
详细描述
Due to COVID-19 restrictions, the BREAK UP study is being conducted as an 8-week home-based before and after intervention study with the aim to improve physical function measured via the WIQ; and to reduce sitting time by up to 60 minutes per day, seven days a week.
Participants will be required to make contact with members of the research team twice to complete assessments remotely, once to complete a coaching consultation, and once per week during the 8-week activity plan to discuss their performance. Organisation of these, and any contact associated with recruitment may require more frequent contact with the research team via telephone or email.
Contact 1 (Recruitment/ eligibility):
Expression of interest to participate will be sought by the treating clinician at Glenfield hospital (listed on the delegation log), who will offer the patient a Participant Information Sheet, contact details form to complete and a consent form. The patient may then be approached by a member of the research team to take their consent, having read the information sheet, or if the participant is happy to be, a member of the research team will contact them within two weeks via telephone and/or email the participant to discuss the study in more detail and determine if they wish to participate or not. After which, they will be asked to complete the consent form and post this back to the research team. Once the signed and dated consent forms have been received, the researcher can organise for the baseline data to be collected.
Contact 2 (Baseline assessments):
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women
- •Age ≥18 years
- •ABPI <0.9 or >1.4 at rest OR >20% decrease post exercise. When ABPI is >0.9 but there is clinical suspicion of PAD, other non-invasive tests, which may include imaging, will be used to confirm diagnosis.
- •History of intermittent claudication (exercise induced, aching/cramping, pain affecting the lower limbs or buttocks, which subsides with rest)
- •Able and willing to give informed consent
- •Able to speak, read, and write English
- •Able to undertake light physical activity
排除标准
- •Individuals with type 1, gestational, or monogenic diabetes mellitus
- •On insulin therapy
- •Hospital admission in preceding 3 months
- •Current or planned pregnancy, or breast feeding
- •Contra-indications to exercise
- •Participation in CTIMP currently and/or in preceding 3 months
- •Already participating in a structured SEP
- •Serious illness with life-expectancy < 1 year
- •Previous major amputation
- •Recent cardiovascular event (within the last 12 months)
- •Comorbidity that the research team considered to be a contraindication to involvement in the study
- •Unable to communicate in English
- •Recent diagnosis or treatment for cancer (within 12 months)
结局指标
主要结局
To investigate overall changes in sitting time
时间窗: 8 weeks
Measured using accelerometers (comparison of time spent sitting at baseline vs. follow-up assessed via acceleration)
The walking impairment questionnaire
时间窗: 8 weeks
Total score for 16 questions measuring walking distance, speed and stair climbing from 0 (worst/inability) to 4 (best/without limitations)
次要结局
- To investigate overall changes in time spent in light physical activity(8 weeks)
- To investigate overall changes in time spent in moderate physical activity(8 weeks)
- To investigate overall changes in time spent in prolonged sitting(8 weeks)
- To investigate whether personalised activity breaks in sitting time improve breathlessness(8 weeks)
- To investigate whether personalised activity breaks in sitting time improve fatigue(8 weeks)
- To investigate whether personalised activity breaks in sitting time improve anxiety and depression(8 weeks)
- To investigate overall changes in time spent in sleep(8 weeks)
- To investigate overall changes in time spent performing physical activity(8 weeks)
- To investigate overall changes in time spent in vigorous physical activity(8 weeks)
- To investigate whether personalised activity breaks in sitting time improve quality of life(8 weeks)