跳至主要内容
临床试验/NCT03264924
NCT03264924已完成不适用

A Single-Centre, Feasibility Study to Promote Physical Activity Uptake and Adherence in Cardiac and Pulmonary Rehabilitation

Liverpool Heart and Chest Hospital NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2017年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
1
主要终点
Percentage enrolment and attendance to rehabilitation

研究概览

简要总结

Cardiac rehabilitation is a programme of exercise and health advice for people recovering from heart disease. Pulmonary rehabilitation is a similar programme for people with chronic lung disease. For both groups of patients, taking part in rehabilitation can lead to improvements in health and well-being. However, only 30% of patients complete their agreed rehabilitation programme. This costs the NHS millions of pounds every year. This project aims to investigate whether a motivational-based intervention, underpinned by self-determination theory and motivational interviewing, will enable staff to encourage more patients to take part in physical activity (PA). Staff will be trained with the new communication skills and will then deliver the rehabilitation programme. The session content will not change, just the way in which staff speak to patients.

This will be a two-phase study. Phase A will take a qualitative approach collect patient and staff feedback about the current rehabilitation programme, before using this information to develop and pilot the intervention. Phase B will then assess the feasibility of the intervention within cardiac and pulmonary rehabilitation. Participants agreeing to take part in the phase B will be required to complete an interview and questionnaire at three time points. Patients' personal opinions of the programmes will be extremely important in discovering what can be done to improve rehabilitation for future participants.

The main objectives will be to look at whether the intervention increases the number of patients taking part in physical activity. The investigators plan to establish how much physical activity patients take part in whilst they are in rehabilitation, as well as once they have left the programme. This is why participants will be interviewed three and six months after they have finished their rehabilitation programme.

详细描述

Background and Rationale

Description of research questions and justification for undertaking the trial Cardiac Rehabilitation (CR) is an effective treatment for CHD and CVD patients, boasting a range of physiological and psychological benefits as well as lowering mortality and risk of secondary cardiac incidents. Despite the aforementioned benefits of CR attendance, uptake and adherence to CR remain inadequate, with cross-cultural surveys demonstrating that only 10-30% of eligible CR patients engage in such programmes. These poor levels of CR participation have been previously attributed to low referral rates amongst healthcare providers, however even within the 30% of eligible patients who become CR participants, the attrition rate is currently 50% and only 20% of attendees report long-term behavioural change. The lack of subsequent engagement with the desired adaptive behaviours is at a great cost to the National Health Service (NHS), with the cost of delivering a "good quality CR service" at £477 per patient and the average cardiac readmission costing £3637. Although physical activity (PA) has been demonstrated to reduce the risk of secondary cardiac incidents, 80% of CR patients fail to maintain regular habitual PA within the first year following a course of CR..

Similarly, Pulmonary Rehabilitation (PR) has been demonstrated to be an effective non-pharmacological intervention for COPD patients, and aims to return the patient to independent functioning, reduce disability and improve quality of life. The clinical conditions for which PR is routinely offered result in progressive loss of function over time. Therefore, any initial beneficial effects of a PR programme are likely to diminish over the subsequent eighteen months. Within this time period however, patients who complete PR have significantly greater quality of life, PA capacity, and fewer days in hospital relative to participants who do not participate in PR . Despite these benefits, uptake and adherence to PR is extremely problematic, with studies demonstrating that less than 50% of patients referred to PR will complete the course. Additionally, adherence rates reported in randomised controlled trials tend to be higher, so even this bleak estimate of adherence may be inflated.

Background Information

A commonality between CR and PR is the patients' participation in physical activity. Regular participation in physical activity (PA) reduces all-cause mortality by 30%, and can help to manage over 20 chronic conditions, including CHD, stroke, type 2 diabetes, cancer, obesity, mental health problems and musculoskeletal conditions. COPD patients' engagement in low-to-moderate intensity daily PA has been shown to enhance their cardiorespiratory health and ability for exertion, and reduce dyspnoea symptoms . Additionally, PA reduces cardiac mortality by 31%, and has been demonstrated to lower blood pressure, and increase 'good' cholesterol in cardiac patients. These effects occur through engagement in relatively low levels of activity: 30 minutes, five times per week.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Percentage enrolment and attendance to rehabilitation

时间窗: June 2018-February 2019.

Measure of percentage enrolment and attendance to rehabilitation.

次要结局

  • Qualitative Impact Evaluation(June 2018-February 2019. Interviews will be conducted upon discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge)
  • International Physical Activity Questionnaire Short Version (IPAQ)(June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.)
  • Treatment Self Regulation Questionnaire (Exercise)(June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.)
  • EuroQol, five dimensions, three levels (EQ-5D-3L)(June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.)
  • Perceived Competence Scale (Exercising Regularly)(June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.)
  • Attendance at Rehabilitation Sessions(Throughout rehabilitation programme (on average 8 weeks).)
  • Perceived Environmental Supportiveness Scale (PESS)(June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.)
  • Relatedness to Others in Physical Activity (ROPAS) Scale(June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.)
  • Test of Exercise Capacity(Test will be completed upon admission to rehabilitation, and at discharge (on average 8 weeks following admission to rehabilitation).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Improving Physical Activity in Rehabilitation | 临床试验