title: Measuring the implementation of a group-based Lifestyle-integrated Functional Exercise (Mi-LiFE) intervention delivered in primary care for older adults aged 75 years or older: a pilot feasibility study protocol.
abstract: BACKGROUND
  Declines in function and quality of life, and an increased risk of cardiovascular events, falls, and fractures occur with aging and may be amenable to exercise intervention. Primary care is an ideal setting for identifying older adults in need of exercise intervention. However, a cost-effective, generalizable model of chronic disease management using exercise in a real-world setting remains elusive. Our objective is to measure the feasibility, potential effectiveness, and implementation of an evidence-based Lifestyle-integrated Functional strength and balance Exercise (LiFE) intervention adapted as a group-based format (Mi-LiFE) for primary care to promote increased physical activity levels in older adults aged 75 years or older. We hypothesize that the intervention will be feasible without modification if ≥30 individuals are recruited over 6 months, ≥75 % of our sample is retained, and ≥50 % of our sample complete exercises ≥3 days per week.
  
  
  METHODS
  A pre-post pilot study design will be used to evaluate feasibility, potential effectiveness, and implementation outcomes over a 6-month period in physically inactive older adults ≥75 years recruited from a local family health team practice. The reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework will be applied to evaluate the public health effects of the intervention including outcomes both at the individual and organizational levels. A physical therapist will teach participants how to integrate strength and balance activities into their daily lives over one individual and four group-based sessions, and two phone calls. Assessments will be completed at baseline and 6 months. Feasibility outcomes include recruitment over 6 months, retention at follow-up, and adherence measured by activity diaries. Change in patient-centered and implementation outcomes that will be evaluated include physical activity levels using accelerometers and International Physical Activity Questionnaire, physical performance using short physical performance battery, quality of life using EQ5D questionnaire, falls and harms using daily calendar diaries and self-report, fidelity using descriptive feedback, barriers and facilitators to implementation using thematic content analysis, and process outcomes.
  
  
  CONCLUSIONS
  The feasibility and implementation of the Mi-LiFE intervention in primary care for older adults will be evaluated, as well as the effects of the intervention on secondary outcomes. If the intervention appears feasible, we will use the resultant information to design a larger trial.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCTO2266225.
authors.affiliation: Department of Kinesiology, University of Waterloo, 200 University Avenue West, Waterloo, ON N2L 3G1 Canada.
authors.forename: Jenna C
authors.initials: JC
authors.lastname: Gibbs
authors.affiliation: Department of Kinesiology, University of Waterloo, 200 University Avenue West, Waterloo, ON N2L 3G1 Canada.
authors.forename: Caitlin
authors.initials: C
authors.lastname: McArthur
authors.affiliation: Centre for Family Medicine-Family Health Team, Department of Family Medicine, McMaster University, 10B Victoria Street South, Kitchener, ON N2G 1C5 Canada.
authors.forename: James
authors.initials: J
authors.lastname: Milligan
authors.affiliation: Faculty of Health Sciences, University of Sydney, 75 East Street Lidcombe, Sydney, NSW 2006 Australia.
authors.forename: Lindy
authors.initials: L
authors.lastname: Clemson
authors.affiliation: Centre for Family Medicine-Family Health Team, Department of Family Medicine, McMaster University, 10B Victoria Street South, Kitchener, ON N2G 1C5 Canada.
authors.forename: Linda
authors.initials: L
authors.lastname: Lee
authors.affiliation: School of Health & Life Sciences and Community Services, Conestoga College, 299 Doon Valley Drive, Kitchener, ON N2G 4M4 Canada.
authors.forename: Veronique M
authors.initials: VM
authors.lastname: Boscart
authors.affiliation: School of Public Health and Health Systems, University of Waterloo, 200 University Avenue West, Waterloo, ON N2L 3G1 Canada.
authors.forename: George
authors.initials: G
authors.lastname: Heckman
authors.affiliation: School of Public Health and Health Systems, University of Waterloo, 200 University Avenue West, Waterloo, ON N2L 3G1 Canada.
authors.forename: Carlos
authors.initials: C
authors.lastname: Rojas-Fernandez
authors.affiliation: School of Public Health and Health Systems, University of Waterloo, 200 University Avenue West, Waterloo, ON N2L 3G1 Canada.
authors.forename: Paul
authors.initials: P
authors.lastname: Stolee
authors.affiliation: Department of Kinesiology, University of Waterloo, 200 University Avenue West, Waterloo, ON N2L 3G1 Canada.
authors.forename: Lora M
authors.initials: LM
authors.lastname: Giangregorio
keywords: Chronic disease management; Exercise; Fall prevention; Older adults; Physical activity; Physical therapy; Primary care