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Table 1 The eight primary areas of focus, outlining the research questions and methods of assessment

From: Assessing the feasibility and impact of an adapted resistance training intervention, aimed at improving the multi-dimensional health and functional capacity of frail older adults in residential care settings: protocol for a feasibility study

Area of focus Research questions Methods of assessment
Acceptability • Will the proposed population be interested in participating in the study?
• What will the uptake be?
• Will the programme be judged as suitable by the delivers of the programme in addition to the programme participants?
• What are participant’s opinions on hypothetically being randomised into a control group during a proposed future clinical trial?*
*Participants within the feasibility study will not be recruited as participants within the proposed future clinical trial in order to protect the scientific validity of a future clinical trial, as the participants within the feasibility study will already have undergone the interventions. Additionally, the intervention may be altered after being informed by this feasibility study as well as utilising Patient and Public Involvement (PPI)).
• Participant uptake analysis (all participants approached and eligible for the study/all of those successfully recruited to the study)
• Semi-structured interviews with participants
• Focus groups with intervention implementers and study support staff.
Demand • Will the proposed population of care home residents participate in the study?
• What will adherence rates be?
• Are the staff in the home open to the idea of having an exercise intervention potentially in the home long term if it proves effective?
• Analysis of uptake rates
• Exercise intervention adherence rates
• Focus groups with study support staff/care home staff.
Implementation • What are the possible logistical issues with the setting which will need to be addressed or accounted for prior to the clinical trial?
• Can the interventions be successfully carried out within this setting?
• Can a single or double bind be successfully implemented within the setting?
• Semi-structured interviews with study participants.
• More in-depth with focus groups with intervention implementers and study support staff.
Practicality • What are the practical implications of the study with relation to the time commitment of the researchers, relating to both the implementation of the intervention, and the testing of participants for the dependent variables of the proposed future clinical trial?
• Is it viable to potentially conduct follow-up testing on participants in the proposed future clinical trial 12 weeks after the intervention at 24 weeks?
• Do any alterations need to be made to the proposed primary dependent variables of the future clinical trial?
• If the intervention is successful in influencing parameters of health and functional capacity, will it potentially be possible to assess if these improvements are sustained during a 12-week follow-up in the proposed future clinical trial if the same is found?
• Semi-structured interviews with study participants.
• Focus groups with support staff and intervention implementers.
Integration • How will the care home staff appraise the study?
• Will the intervention be easily integrated into the existing culture, protocols and procedures within the care home seamlessly?
• Focus groups with support staff and intervention implementers.
Adaptation • Will any further adaptations be required to the existing intervention to make it more feasible or appropriate within this setting? • Focus groups with intervention implementers.
• Semi-structured interviews with participants.
Expansion • Can the HUR equipment be successfully utilised in (and its use expanded to) this setting? • Semi-structured interviews with study participants
• Focus group with intervention implementers.
Limited-efficacy testing • Is 6 weeks (or potentially 12 weeks in the case of the proposed future clinical trial) a sufficient duration to potentially provide significant benefit to patients? (This will inform the time points at which testing will occur within the future clinical trial)
• Can a moderately intensive (3–4 days per week), 6-week (12 weeks potentially in the case of the proposed future clinical trial) specially adapted resistance training intervention improve markers of multi-dimensional health in frail elderly individuals?
• Analysis of the patient-centred outcomes within the study (primary dependent variables of the proposed future clinical trial).
• Analysis of uptake and adherence rates.
• Analysis of the level of satisfaction with the interventions through semi-structured interviews and focus groups with participants and intervention implementers respectively, post intervention.