The Home-Based Older People's Exercise (HOPE) trial: study protocol for a randomised controlled trial

Bradford, UK; a post-industrial ethnically diverse northern city with a population of 350,000 people.

Those eligible for inclusion are frail older people. A research question under investigation in this pilot trial is to identify the most efficient recruitment method(s) for this hard to reach group of people. We have therefore used multiple recruitment sources to identify frail older people:

The initial method of approach for those identified through GP registers of NIHR Research Ready practices is by letter from the GP practice. The initial method of approach for all other potential participants is by face-to-face or telephone contact from the healthcare professional or senior member of social services staff who is co-ordinating care.

The development of the HOPE programme has followed a three-stage process that has been informed by the MRC framework [10]. Firstly, international guidelines on the development of exercise interventions for older people from the American College of Sports Medicine (ACSM) and the American Heart Association (AHA) were reviewed [12]. These guidelines recommend that exercise interventions for older people should be multi-dimensional and include exercises to improve whole body muscle strength, mobility, balance and aerobic capacity.

Secondly, a systematic review of the literature was conducted to identify RCTs of high methodological quality that investigated home-based exercise interventions for frail older people. This review was supported by an earlier systematic review of exercise interventions for frail older people in long-term care [13]. The key components of the exercise interventions in the successful RCTs of high methodological quality were then identified to inform the frequency, intensity and duration of the intervention.

Thirdly, a series of multiperspective focus group meetings with frail older people and experienced healthcare professionals were conducted. The meetings were audio-recorded and transcribed to enable a thematic analysis of the qualitative data using grounded theory methods. The key aims and objectives of these focus group meeting were to identify key physical limitations and difficulties with activities of daily living (ADL) in frail older people living at home. This was to enable the selection of appropriate exercises to address these limitations and difficulties. The key physical limitations identified from the thematic analysis were; muscle weakness; pain and stiffness in joints; poor balance; poor postural stability and flexibility; and breathlessness. Important difficulties in ADL were standing up from a chair; getting out of bed and climbing stairs. Although aerobic exercise for older people is recommended in the ACSM and AHA guidelines, the multiperspective focus group meetings identified that aerobic exercise for frail older people would be difficult to achieve, particularly in those who are most frail because of limits in energy expenditure.

Following this three stage process, a draft intervention was produced. The draft intervention was further refined by expert consensus using Delphi methodology [14] to produce the HOPE programme - an evidence based, user defined exercise intervention for frail older people living at home.

The HOPE programme is a 12 week progressive exercise intervention which is presented to participants in an exercise manual and delivered by trained community-based physiotherapists from Bradford Teaching Hospitals NHS Foundation Trust. The manual contains five sections; 1) information, 2) safety tips, 3) good posture, 4) exercises and 5) staying on track. The exercises have been selected to target the physical limitations and ADL difficulties identified by the focus group meetings and refined through the consensus process. To account for the diversity of our participant group, the HOPE programme is graded into three levels. Participants are stratified to the appropriate level using the baseline timed-up and go test [15]. All of the exercises are easy to learn, require no special equipment and can be performed without professional supervision. The exercises for each level of the programme (Level 1, 2 and 3), their purpose (to improve strength, mobility, balance or aerobic capacity) and their functional relevance (e.g. to improve standing up from a chair) are provided in Additional file 1, appendix 1.

At the beginning of the intervention participants are requested to perform five repetitions of each exercise in the routine. This progresses to 10 and then 15 repetitions as performance improves. The exercise routine takes less than 15 minutes to complete, and participants are requested to complete the routine 3 times a day on 5 days of the week.

Participants receive weekly support from physiotherapists through either a face-to-face home visit or telephone call (Figure 1). If participants are coping well with the exercises they are encouraged to progress within the programme. Progression is by increasing repetitions, introducing new exercises or advancing to the next level of the HOPE programme (Figure 1). Gentle aerobic exercise is incorporated as a progression exercise at Level 3 of the HOPE programme to introduce the concept of aerobic exercise to the more physically able participants.

The HOPE programme is based predominantly on the social cognitive model of behaviour change as a theoretical framework, and this has previously been shown to successfully increase physical activity participation in adults [16‐19]. Details of the behaviour change techniques and how they are incorporated into the HOPE programme are shown in Table 1.

A successful pilot RCT provides important information regarding process, resources, management and scientific data [20]. This pilot RCT is designed to explore:

To provide useful process, resources, management and scientific data we aim to recruit 100 participants (50 per group). The results from our pilot RCT will inform the feasibility, design and power calculation for a future definitive RCT.

Participants undergo central, concealed randomised allocation to intervention or usual care. Participants are stratified by the baseline timed up and go test and undergo randomisation using restricted blocks of random size with an allocation ratio of 1:1. Generation and storage of the HOPE trial randomisation sequence, and conduction of individual participant randomisation is conducted by the University of Leeds Clinical Trials Research Unit (CTRU), ensuring allocation concealment.

Baseline assessment is conducted by an elderly care researcher and includes age, sex, cognitive assessment, co-morbidity index [21] and the Edmonton Frail Scale (EFS), a validated and reliable measure of frailty [22]. The EFS samples 10 domains, including cognitive impairment, functional ability and mobility. The maximum score is 17, which represents the highest level of frailty. The EFS demonstrates good inter-rater reliability (estimated κ = 0.7) and internal consistency (Cronbach's α = 0.62).

Involvement in previous formal exercise programmes and the dates of any previous involvement are also recorded.

1. Timed Up and Go test (TUGT) [15], measured at baseline and 14 weeks post-randomisation. The TUGT measures, in seconds, the time taken to stand up from a standard chair, walk a distance of 3 metres, turn, walk back to the chair and sit down. A chair with armrests and a seating depth of 44-47 cm is recommended. Those who complete the test in less than 20 seconds tend to be independently mobile, able to get in and out of a chair without assistance and climb stairs. Those who complete the test in 30 seconds or more tend to require assistance with getting in and out of a chair, climbing stairs and leaving the house. Those who complete the test in 20-29 seconds demonstrate greater variability in mobility, balance and functional ability [15]. The TUGT score demonstrates high inter-rater and intra-rater reliability (intraclass correlation coefficients (ICCs) 0.99 and 0.99 respectively) and correlates well with measures of gait speed, functional ability and balance. An improvement of 1.4 seconds on the TUGT (within-patient change score) has been identified as the minimum clinically important difference (MCID) [23].

We are also recording recruitment rates; proportions and reasons for non-consent; protocol compliance by therapists; rates of adherence to the HOPE programme by patients; drop out rates; rates of completion of outcome measures; unscheduled admissions to hospital. We also record falls and document muscle/joint pain.

We anticipate that the main cost of the intervention will be the future therapy resources associated with delivery of the HOPE programme. To perform a formal cost-effectiveness analysis in the future definitive trial, we will therefore test the feasibility of collection of data to identify the therapy resources required for delivery. This data will be recorded by the physiotherapists who deliver the intervention and will include time taken for each physiotherapist home visit, time for telephone consultations and travel time.

The exploratory nature of this pilot study requires mainly descriptive statistics and will focus on the estimation of effects sizes, 95% confidence intervals and variation estimation for planning of the future definitive trial. We will compare the baseline differences between the control and intervention groups in terms of the baseline assessment tests and assess differences in any other potential confounding variables (age, sex, co-morbidity).

All outcome measures will be summarised and 95% confidence intervals constructed for the difference in outcomes between control and intervention groups. Analysis of covariance (ANCOVA) tests will be used for continuous outcomes, with adjustment for baseline values. Both adjusted and unadjusted values will be reported to detect which has the smaller variance for future planning. Risk ratios with 95% confidence intervals will be used for binary outcomes and rate ratios with resulting 95% confidence intervals will be used to assess rates.

The final intention-to-treat analysis will include all randomised participants for whom the follow-up assessment of the primary outcome measure is available. The per-protocol analysis will include all randomised participants who are deemed to have no protocol violations.

Participants who are randomised to the HOPE programme (intervention) arm but do not undertake any of the HOPE programme are deemed to be protocol violations.

Safe exercise guidelines are followed and exercise intensity is increased gradually by therapists with experience in the delivery of exercise interventions to frail older people living at home. All potential participants are informed of the potential risks in the participant information documents provided, so that informed consent is taken with full knowledge of potential risks.

An adverse event (AE) is any unfavourable and unintended sign, symptom, syndrome or illness that develops or worsens during the period of observation in the trial. This includes:

A serious adverse event (SAE) is any AE occurring following trial mandated procedures that results in any of the following outcomes:

All AEs are assessed for seriousness, causality and expectedness by the trial chief investigator and recorded and closely monitored. The chief investigator is informed immediately following any SAE to determine causality and expectedness. Any SAE that is deemed to be directly related to the trial intervention, or suspected to be related to the trial intervention, will be reported immediately to the ethics committee.

Informed, written consent is obtained from all trial participants by an elderly care researcher during a visit to the participant's home. Consent is in full accordance with the Mental Capacity Act 2005 [29] and International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) [30]. It is emphasised that participants are free to withdraw from the trial at any time and that this will not affect the future care that they receive.

Ethical approval for the HOPE trial has been granted by the Bradford Research Ethics Committee (application number 09/H1302/55). NHS Research & Development (R&D) approval has been granted by NHS Bradford and Airedale and Bradford Teaching Hospitals NHS Foundation Trust.