Feasibility of a physical activity programme embedded into the daily lives of older adults living in nursing homes: protocol for a randomised controlled pilot feasibility study

The primary aim of this pilot feasibility study is to assess the feasibility and acceptability of a PA intervention embedded into the daily lives of older adults living in nursing homes. The secondary aim is to examine the preliminary effects of this on physical mobility and quality of life, compared to participants receiving usual care. It is intended that this will facilitate the refinement of the PA programme where needed and will facilitate the development of a clear protocol for subsequent evaluation of the PA intervention in a larger, definitive RCT. The primary and secondary research questions are listed in Table 1.

A randomised controlled pilot feasibility study, with embedded qualitative and economic components, will be carried out. Two nursing homes will take part in the study; participants in one nursing home will receive the PA intervention and participants in the other will receive usual care. In order to avoid contamination between intervention and control groups, randomisation will take place at nursing home level [12]. The pilot feasibility study will not be an exact scale model of a definitive RCT, the difference being that follow-up outcome assessment will not be blinded as a full analysis of outcome data is not intended. However, the recruitment, randomisation, assessment and intervention conditions will be similar to a definitive RCT in order to answer the feasibility research questions. Figure 1 provides a CONSORT flow diagram displaying the movement of participants throughout the study. A schedule for enrolment, interventions and assessments is displayed in Fig. 2. The protocol adheres to the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT) guidelines (Additional file 1) [21] and the SPIRIT-Patient Reported Outcomes Extension [22].

The pilot feasibility study will take place in two Irish nursing homes. Nursing home and participant eligibility criteria are outlined in Table 2.

An objective of this study is to assess the feasibility of recruiting and retaining the required number of participants per nursing home which would be needed in a definitive RCT. Therefore, the sample size calculation for this pilot feasibility study is based on the estimated power calculation for a definitive cluster RCT using the primary outcome measure, the Timed Up and Go (TUG) test [23]. In the absence of normative TUG data for an Irish cohort of older adults living in nursing homes, sample size calculations for a definitive RCT were estimated using a New Zealand sample of older adults living in residential care [12]. The sample size requirements for a definitive RCT were calculated as being a minimum of four clusters of size 20 in each arm, in order to have 80% power (α = 0.05) to detect a mean change in TUG score of 4.7 s (± 6.8 s). The current study will recruit one nursing home for each arm. The desired number of participants in each nursing home will be maintained as 20 in order to assess the recruitment potential, recruitment time and feasibility of delivering the intervention to this number of participants. The number of participants lost to follow-up per nursing home will be recorded to inform the final numbers needed when recruiting to the definitive RCT.

Key elements of SCT have been incorporated into the PA intervention, using the strategies outlined in Table 3. The PA intervention will comprise three components led by a researcher who is a qualified physiotherapist.

The researcher will meet with each participant individually to educate them of the benefits of PA in their own context and to facilitate participants in setting a small number of activity-based goals that they would like to achieve over the intervention period. Goals should be in relation to performing a physical task, such as walking to the dining area for meals, participating in particular group activities or gardening. The Bangor Goal Setting Interview [26] will provide a structured format for the goal-setting process. First, the researcher will facilitate the participant to explore different domains of daily life and identify issues of importance to them that may form the basis of goals. The importance for change and readiness to change in each of these areas will be explored using the principles of motivational interviewing. The researcher will facilitate the participant in revisiting each area and choosing the desired goals using SMART (specific, measurable, achievable, realistic and timely) criteria. The researcher and participant will work together to set goal attainment indicators, which will provide clear descriptors of what would constitute 25%, 50% and 75% goal attainment [26]. Finally, the participant will be asked to rate their current performance and satisfaction with performance on a Likert scale of 1–10 (where 1 means cannot do or am not doing successfully and 10 means can do and am doing very successfully). A visual representation of this scale will be used to assist participants. A separate, independent rating of goal attainment will be recorded by the researcher following observation. Barriers and facilitators to achieving the goal will be discussed with an emphasis on resources that will help in overcoming obstacles and achieving their goals.

Using the information gathered from the baseline assessment and goal-setting exercise, a PA programme will be developed by the researcher and tailored to each participant. The participant will be given an opportunity to refine the PA programme with the researcher before it is finalised, as participant satisfaction with PA interventions is important for adherence [27]. PA programmes will be carried out on three days per week. Integral to each PA programme will be a walking component (i.e. structured and gradual increases in daily walking time) and sit-to-stand exercises (i.e. a specified number of repeated rises from a chair). These are functional and accessible means of providing the aerobic and resistance components considered as important to PA programmes [28]. Opportunities for walking will be identified with each participant and the care staff. This will be based on lengthening walks that the participant is already undergoing. For example, the participants’ walk to or from the dining area or their walk from the bedroom to the seating area will be increased by 1–5 min initially and progressed to a maximum of 10 min. Where possible, participants will be encouraged to walk with others, as exercising with peers has been shown to enhance adherence to and persistence with an exercise program among older adults [29]. Sit-to-stand exercises will be embedded into the participant’s daily routines, for example rather than rising from a chair once, participants will complete a series of sit-to-stands in their bedroom, the dining room or the seating area. Depending on individual ability, this will begin as two sets of 2–5 repetitions initially and progressed to a maximum of three sets of 15 repetitions. The remaining components of the PA programme will be tailored around each participant’s specific functional goals and will be based on repeating particular functional and meaningful activities. The researcher will progress each PA programme as tolerated by each participant. All participants in the intervention group will commence the PA programme at the same time.

A poster displaying the participant’s goals and PA programme will be visible on the wall in their bedroom to promote adherence. Where possible, participants will be encouraged to document their own adherence to their PA programme using an easy-to-complete diary provided by the researcher, detailing the time spent walking and the number of repetitions achieved for each activity. Where cognitive or physical barriers prevent participants from completing their own adherence diary, the staff will be responsible for completing the diary for them. When the PA occurs upon the participant getting up in the morning, the staff member assisting the participant in getting up will be responsible for completing the adherence diary. For daytime PA, the staff member who supervises the PA will document adherence on a centrally placed progress board. Space will be provided to detail any deviations or modifications of the PA programme. Recording adherence to PA on a daily basis like this provides the most detailed data [30] and is less susceptible to recall errors which are evident in many retrospective PA questionnaires [31].

All nursing home staff will be invited to attend two education sessions. The first session will take place at the beginning of the intervention and the second at the midway point. Table 4 outlines the content of these educational sessions. Staff will be responsible for overseeing the completion of the participant’s PA programmes which may involve providing reminders, encouragement or assistance with PA programmes and assistance with documenting adherence. The researcher will support the nursing home staff to supervise the participants PA programmes through twice weekly support visits and ongoing telephone support. Posters will be displayed on the nursing home notice boards to highlight the impact of PA on health and wellbeing and to generate awareness of the study among nursing home staff, residents and visitors.

The participants in the control group will receive usual care, which will be guided by current nursing and medical care plans. Participants in the control group are not restricted in any way regarding their PA behaviour. However, participants will be asked to document any changes in PA which occurs during the intervention period and the researcher will verify this with the key nurse at each follow-up. The feasibility and time taken to collect this information will be documented. At the end of the intervention, if a positive outcome is indicated, the nursing home staff which takes part in the control arm will be provided with the materials used in the intervention arm. The researcher will also deliver an educational session and guidance on how to deliver the programme in their nursing home.

A preliminary health economic assessment of the intervention relative to the usual care control will be conducted using a cost-effectiveness analysis and cost-utility analysis. The evaluation will be undertaken in a manner consistent with the guidelines issued by Health Information and Quality Authority for the assessment of healthcare interventions and technologies in Ireland. Resource use associated with delivery of the PA intervention will be measured and costed. In particular, resources relating to educational sessions, healthcare professional time input, consumables and materials, equipment and overheads will be measured. A form detailing the resources used by participants over the previous three months, including health service usage, medication usage and private healthcare or study expenses will be completed in both intervention and control groups at baseline, three-month and 12-month follow-up. The researcher will gather this information in consultation with the lead nurse involved in the study, the participant and the participant’s medical notes. The time taken and sources used to obtain this information will be recorded by the researcher. Unit costs will be applied to convert data on resource use to resource costs and total cost variables will be calculated. Data collected from the primary outcome measure, the TUG, at each time point will be used alongside resource usage to provide the basis for the cost-effectiveness analysis. For the cost-utility analysis, effectiveness will be evaluated based on the quality-adjusted life year, which is the preferred outcome measure for economic evaluation and which will be estimated using the EuroQol EQ-5D-5 L instrument [48], assessed baseline, three-month and 12-month follow-up. An incremental cost-effectiveness analysis will be undertaken to provide information on the marginal costs and marginal effects of the intervention relative to the control. The output from the pilot study will provide information on the potential costs and cost-effectiveness of the intervention, as well as the feasibility of collecting the required data, which will inform the design of a definitive RCT.

A qualitative descriptive approach [49] will be taken for the qualitative component of the study. A sample of ten participants from the intervention group will be invited to take part in an audio-recorded, one-to-one semi-structured interview within one month of intervention completion. An interview guide will be developed using established guidance [50, 51] and will explore the participant’s experiences of receiving the intervention, the feasibility and acceptability of the intervention, and the perceived effects of the intervention, including potential AEs. The researcher will explore the participant’s adherence to the programme and any adaptations made to it, as well as the acceptability of the recruitment, consent and outcome assessment processes of the study. The interview will also examine the factors which could facilitate or hinder participants in maintaining their PA levels. These could include environmental factors, personal factors or support from care staff.

Staff from the intervention site will also be invited to take part in a one-to-one semi-structured interview, within one month of intervention completion. A variety of staff (manager, nurse, care staff) will be sought in order to maximise variation in the sample. Staff will be included if they have had a role in recruitment or delivery of the intervention. The interview will explore the staffs’ role and experiences of being involved in the study, including their participation in the staff education sessions and the monitoring of the PA programmes. It will also explore the staff’s perceptions of the potential for sustaining the PA programme within the nursing home following the study.

Semi-structured qualitative interviews will be conducted with a small subset of participants from the control group. It will focus on obtaining a description of usual care and evaluating participant’s experiences during recruitment.

Protocol version 6. Recruitment began in March 2018 and will end in June 2018.