The Role of Activity Monitors in Improving Physical Activity in COPD Patients Participating in Pulmonary Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Daily physical activity measured as: A: number of minutes active during the day; B: number of steps*
研究概览
简要总结
In patients with Chronic Obstructive Pulmonary Disease (COPD) lifestyles with lower physical activity levels have been shown to increase the risk of hospital admissions and shorten survival rates. An established process in increasing activity levels is to undergo pulmonary rehabilitation classes.
The investigators wish to identify whether the use of activity monitors,which will provide feedback on activity levels, will increase the physical activity levels of patients with COPD outside of the supervised pulmonary rehabilitation sessions.
详细描述
The research proposal has been developed in conjunction with the Respiratory Physicians and Physiotherapy team who deliver the pulmonary Rehabilitation sessions.
The investigators want to address if providing patients with monitors to record activity levels and then giving feedback on activity level data enhances the effect of the standard pulmonary rehabilitation program. The investigators want to pay particular attention to the levels of activity outside the duration of the rehabilitation classes - to see if higher levels of activity are reached.
This aims to be a feasibility study done on a small scale where issues such as compliance with wearing the device can be monitored closely. Compliance will be reviewed during a one week trial of wearing the device prior to starting the rehabilitation sessions. It will also enable study participants to get into the routine of wearing the device, charging etc.
Analysis of the data will be data collected during weekdays, choosing the 4 weekdays where there is a minimum of 8hrs of wearing time during waking hours. If the device has been worn for less than 8 hours, then days with most wear-time of the device will be selected. This method was chosen as it is a robust and statistically validated method of assessing activity levels in patients with COPD.
All study participants will be asked to wear the activity monitor to minimise any bias in the collected data. Subjects will be randomised as to whether they receive feedback or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed COPD diagnosis with spirometry: Forced expiratory volume at one second (FEV1)/Forced Vital Capacity (FVC) <70%
- •Optimised pharmacology intervention
- •Referred for Pulmonary Rehabilitation
排除标准
- •FEV1 <30% predicted
- •Clinical instability - Exacerbation in preceding 6 weeks
- •Other clinical condition that prevents mechanical exercise (and therefore participation in sessions) due to pain/discomfort (Arthritis etc.)
- •None compliant with the use of the activity monitors. Compliance will be assessed during the 1 week before starting the pulmonary rehabilitation programme (at the same time of collecting baseline data on activity). Compliance will be defined as wearing the activity monitors for at least 85% of the time allowing for times to take it off for charging.
- •Recurrent chest infections >3 in the past 12 months.
- •Unable to consent
结局指标
主要结局
Daily physical activity measured as: A: number of minutes active during the day; B: number of steps*
时间窗: Through Study completion, upto 7 weeks total
from the data recorded on the device
次要结局
- Assessment of symptom severity using Copd Assessment Test (comparing the 2 groups and in comparison to baseline)(Through Study completion, upto 7 weeks total)
- Self reported exercise diary - duration of exercise(Through Study completion, upto 7 weeks total)
- Self reported exercise diary - BORG (perceived activity levels and effort scale)(Through Study completion, upto 7 weeks total)
- Assessment of symptom severity using the Chronic Respiratory Disease Questionaire Score (comparing the 2 groups and in comparison to baseline)(Through Study completion, upto 7 weeks total)
- Assessment of exercise capacity: 6 minute walk test (comparing the 2 groups and in comparison to baseline)(At beginning and at 7 weeks, with repeat at 6 months)
- Assessment of symptom severity using Hospital Anxiety and Depression Scale (comparing the 2 groups and in comparison to baseline)(Through Study completion, upto 7 weeks total)
- Assessment of symptom severity using the Patient Activation Measure Score (comparing the 2 groups and in comparison to baseline)(Through Study completion, upto 7 weeks total)