Background: Low-quality social relationships in older adults are strongly associated with feelings of loneliness. Physical activity interventions could reduce loneliness and improve psychological well-being, among other health benefits. The aim of this study is to examine the feasibility of a Physical Activity Intervention for Loneliness (PAIL) in community-dwelling older adults at risk for loneliness.
Methods/design: This feasibility study is a two-arm randomised controlled trial (RCT) with a wait-list control group using a mixed-methods research design. The primary aim of the feasibility study is to estimate recruitment, retention and adherence rates; the appropriateness of the intervention design and its practicality; the acceptability of the intervention by participants; and the set of instruments and measures and primary outcome measures to inform a future large-scale randomised trial. After eligibility screening, randomisation will be conducted using computer-based random sequence generation. Baseline and post-intervention assessments for intervention and control groups will include height, weight, body mass index, resting blood pressure, physical activity using accelerometry, loneliness, social support, social networks, anxiety and depression, self-efficacy for exercise, satisfaction with social contacts, and expected outcomes and barriers for exercise using questionnaires. Focus groups will be conducted at the mid-point and post-intervention period using a phenomenological approach to analyse the participants' experiences of taking part in PAIL.
Discussion: This trial will provide important information regarding the feasibility of PAIL in community-dwelling older adults at risk for loneliness using a mixed-methods approach combining quantitative and qualitative research methods.
Trial registration: Clinicaltrials.gov NCT03458793.
Keywords: Feasibility study; Loneliness; Older adults; Physical activity; Randomised controlled trial.