Clinical trial NCT03264924: Improving Physical Activity in Rehabilitation
Official title: A Single-Centre, Feasibility Study to Promote Physical Activity Uptake and Adherence in Cardiac and Pulmonary Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Keywords: physical activity
motivation
behaviour change
Lead sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Edge Hill University
First posted: 2017-08-29
Enrollment: 82
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac and pulmonary rehabilitation patients and staff.

Brief summary: 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.

Detailed description: 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.

Despite these far-reaching benefits, patients are less likely than non-symptomatic individuals to engage with PA. In 2015, a report by the Academy of Medical Royal Colleges portrayed PA as a 'miracle cure', which despite having a better disease risk reduction than many drugs, is often overlooked by healthcare providers and their patients. Worryingly, with the number of older people with multiple medical problems increasing rapidly, less than a third of UK adults over the age of 65 meet the minimum levels of PA.

Theoretical Underpinning

Motivation is a key component of behaviour change. With the focus on the motivational aspects of behaviour change in mind, Self-Determination Theory (SDT) has become an increasingly commonly used theory to design health behaviour change interventions . According to SDT individuals adopt or change behaviour on the basis of internal satisfaction and fulfilment, termed as intrinsic motivation. Alternatively, individuals are less likely to adopt or change behaviour when a reward or inducement provided by an external person is used to compel a person to act, known as extrinsic motivation. Environments that support intrinsic motivation optimise behavioural effort, persistence and performance. In contrast, environments that coerce through rewards serve to diminish behavioural effort, persistence and performance .

Previous SDT research has demonstrated that intrinsic motivation towards treatment is positively associated with adherence to medical regimes among people with chronic illnesses, attendance/involvement in an addiction treatment program, and long-term maintenance of weight loss among morbidly obese patients. Within physical activity research, intrinsic motivation has been found to be strongly associated with physical activity engagement. Similarly, increases in intrinsic motivation from pre- to post- exercise referral scheme significantly predicted greater adherence to the scheme as well as greater sports-related physical activity. The dense body of SDT research in health, including physical activity, suggests that interventions underpinned by SDT, should develop and support intrinsic motivation in order to optimally motivate engagement with PA.

Motivational interviewing (MI) is a method of strengthening personal motivation for change, and has been shown to be a promising approach for promoting health behaviour change in a number of contexts including physical activity promotion. MI comprises several techniques used by practitioners to facilitate behaviour change in patients. Some techniques focus on the content of the intervention, whereas others focus on techniques reflect the practitioner's interpersonal style of delivery. One of the primary roles the MI approach is to evoke the patient's arguments for change and to reduce their own arguments for not changing.

Research Critique

Motivational theories that inform behaviour change (for example, SDT) do not typically feed through to into instructor training programmes, particularly in clinical rehabilitation settings. Therefore, a significant limitation of motivational theory to date is its ability to be translated into clinical practice. Accordingly, it is important that attempts are made to ensure motivational theory is translated effectively in clinical practice in order to increase patients' motivation for physical activity uptake and adherence in cardiac and pulmonary rehabilitation. The current research, therefore, will combine a well-established motivational theory (i.e., Self-Determination Theory) with established motivational practice (i.e., Motivational Interviewing) in an attempt to integrate theory and practice, offsetting Ntoumanis et al's. claims that contemporary motivation research does not typically feed through to instructor programmes.

Previous researches aiming to increase physical activity motivation in rehabilitation have predominantly focused on interventions at an individual-level. Whilst it is important not to completely disregard this approach, the NHS rehabilitation setting is typically a place where clinicians have to facilitate sessions on a group-level. Furthermore, the NHS may not have the resources to provide the sufficient level of treatment fidelity that one-to-one approaches require in order to be successful. Therefore, the current research will equip clinicians with skills to be effective for increasing group-level physical activity motivation, as well as on an individual level.

Motivational-based intervention research for changing increasing physical activity behaviour in clinical rehabilitation settings has predominantly focused on intervention effectiveness for changing behavioural outcomes. However, the intervention development, delivery and content are not often reported, therefore, limiting the applied utility and replication of the intervention itself. As such, the current research will pilot and feasibly investigate the development of a motivational-based intervention. Doing so will provide a more nuanced understanding for motivating cardiac and pulmonary patients' uptake and adherence to physical rehabilitation activity. Such information would also be crucial for informing a future RCT trial.

Eligibility criteria: 1. Inclusion criteria - Patients will be included when they enrol into cardiac and pulmonary rehabilitation programme due to heart disease or chronic obstructive pulmonary disease.
2. Exclusion criteria - They will be excluded if they have previously completed a cardiac/pulmonary rehabilitation programme.

Primary outcomes:
measure: Percentage enrolment and attendance to rehabilitation
timeFrame: June 2018-February 2019.
Secondary outcomes:
measure: Qualitative Impact Evaluation
timeFrame: 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
measure: Treatment Self Regulation Questionnaire (Exercise)
timeFrame: 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.
measure: International Physical Activity Questionnaire Short Version (IPAQ)
timeFrame: 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.
measure: EuroQol, five dimensions, three levels (EQ-5D-3L)
timeFrame: 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.
measure: Perceived Competence Scale (Exercising Regularly)
timeFrame: 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.
measure: Perceived Environmental Supportiveness Scale (PESS)
timeFrame: 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.
measure: Relatedness to Others in Physical Activity (ROPAS) Scale
timeFrame: 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.
measure: Test of Exercise Capacity
timeFrame: Test will be completed upon admission to rehabilitation, and at discharge (on average 8 weeks following admission to rehabilitation).
measure: Attendance at Rehabilitation Sessions
timeFrame: Throughout rehabilitation programme (on average 8 weeks).
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital NHS Foundation Trust
state: Merseyside
Study officials:
affiliation: Liverpool Heart and Chest Hospital NHS Foundation Trust/ Edge Hill University
name: Adrian W Midgley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Liverpool Heart and Chest Hospital NHS Foundation Trust
name: Bashir Matata, PhD
role: PRINCIPAL_INVESTIGATOR
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