Physical activity is a strongly recommended intervention for older adults, as randomized controlled trials have demonstrated positive effects of physical activity on a variety of outcome domains (e.g., falls, cognition, mobility, and mood, among others). However, physical activity trialists lack appropriate guidance on which outcome domains to measure consistently, leading to considerable heterogeneity in outcome selection and reporting across physical activity randomized controlled trials for older adults. This heterogeneity contributes to bias and makes it difficult to compare, contrast, and combine results across trials. In turn, lack of consistency in outcome selection and reporting makes it challenging to identify effective, ineffective, and unproven physical activity interventions in a timely manner, and thereby impedes future health research, health care decision making, and development of physical activity policy and public health programs to support aging. Furthermore, outcome selection in previous randomized controlled trials has not been guided explicitly by priorities of older adults or their health care professionals, which diminishes the real-world applicability of trial results. Therefore, we aim to develop a core outcome set (COS) for randomized controlled trials of physical activity interventions for older adults. We anticipate this will improve outcome reporting consistency, enhance evidence quality, and reduce research waste.
This is a multi-phase project:
Phase 1 (Knowledge Synthesis): We conducted a rapid review to identify outcome domains and subdomains that have been measured in previously published randomized controlled trials of physical activity for older adults.
Phase 2 (Knowledge User Perceptions – Older Adults): Too little attention has been directed to ensuring that randomized controlled trials of physical activity interventions for older adults are measuring patient-relevant outcomes. The objective of this study was to understand what outcomes related to their physical activity participation older adults find important.
Phase 3 (Knowledge User Perceptions – Health Care Professionals): If outcomes that are relevant to health care professionals were routinely measured in research trials, it could aid in their willingness, ability, and desire to promote and prescribe physical activity in their practice. The aim of this study is to determine which outcomes associated with older adult physical activity participation that key health care professionals who work with older adults deem most important.
Phase 4 (Consensus Generation): In this phase we will convene an expert panel comprised of physical activity researchers/clinical trialists/systematic reviewers, health care professionals (e.g., Physiotherapists, Kinesiologists), and older adults. The panel will participate in a modified, multi-round, online Delphi study to generate consensus on which outcome domain to include in a core outcome set for randomized controlled trials of physical activity interventions for older adults.
Potentially Relevant Existing COS:
Existing COS by Crocker et al. 2022 and Gonclaves et al. 2019 also deal with physical activity, but there are important differences in the interventions, populations, and health conditions of these existing COS that justify development of this new COS.
Crocker et al. 2022 developed a COS for public health trials evaluating interventions that promote physical activity in the general adult population. Such trials would measure physical activity behavioural outcomes (e.g., physical activity duration, intensity, level, etc.). Our efforts are distinct, as we are developing a COS for randomized controlled trials that deliver physical activity interventions in the older adult population and measure the impacts of those physical activity interventions on a range of health outcome domains (e.g., physiological, clinical, emotional, social). Further, the population for the Crocker et al. COS is the general adult population, which is much broader than the older adult population for the current COS. This is critically important because in the field of physical activity, many outcomes are age-specific. Considering these differences in interventions and populations, the COS scope comparison framework from Saldanha et al. 2021 indicates that the Crocker et al. COS is unlikely to be relevant.
Goncalves et al. 2019 developed a COS for trials that deliver physical activity interventions to people living with dementia; as such, the Goncalves et al. COS addresses a different health condition (i.e., dementia) than the current COS (i.e., ageing, without reference to a specific disease). In and of itself, this difference in target conditions provides strong justification for developing a new COS. Further, the population of interest in the Goncalves et al. COS is people living with dementia, which is a much narrower and more specific population than our focus on the general older adult population. The Goncalves et al. COS comprises outcome domains that are specific to the needs, desires, and capabilities of the specific subpopulation of people living with dementia, which do not necessarily generalize to needs, desires, and capabilities of community-dwelling older adults. In addition, the nature of physical activity interventions delivered to people living with dementia are often quite different in scope than physical activity interventions delivered to the general older adult population. Therefore, the outcome domains that are relevant to assess inherently differ. Considering these differences in health conditions, populations, and interventions, the COS scope comparison framework from Saldhana et al. 2021 indicates that the Goncalves et al. COS is unlikely to be relevant.
In summary, a new stand-alone COS is necessary to specify a minimum set of outcome domains that are essential to measure in randomized controlled trials that deliver physical activity interventions to older adults. The existing COS from Crocker et al. 2022 and Goncalves et al. 2019 address different health conditions, interventions, and populations.
Dr. Dawn C. Mackey, Principal Investigator, Associate Professor, Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, British Columbia, Canada
Dr. Christina L. Ekegren, Co-Investigator, Senior Research Fellow, Rehabilitation, Ageing and Independent Living (RAIL) Research Centre, Monash University, Frankston, Victoria, Australia
Dr. Claire E. Baldwin, Co-Investigator, Associate Professor, Physiotherapy, Flinders University, Adelaide, South Australia, Australia
Sarra Pirmohamed, MSc Student, Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, British Columbia, Canada
Peter J. Young, PhD Candidate, Department of Biomedical Physiology and Kinesiology,Simon Fraser University, Burnaby, British Columbia, Canada
Disease Category: Health care of older people
Disease Name: N/A
Age Range: 55 - 120
Sex: Either
Nature of Intervention: Physical, Exercise
- Consumers (patients)
- Clinical experts
- Researchers
- COS for clinical trials or clinical research
- Interview
- Delphi process
- Literature review
- Survey
Phase 1 (Knowledge Synthesis): We conducted a rapid review to identify outcome domains and subdomains that have been measured in previously published randomized controlled trials of physical activity for older adults. Our search yielded 548 articles; 67 articles were eligible to be included. We found extensive variability in outcome domains and subdomains used in RCTs of PA for older adults, and no outcome domains or subdomains were reported consistently in all RCTs. These results reflect the broad range of potential health benefits derived from PA and also investigator interest to monitor a range of safety parameters related to adverse events. Our rapid review was published in 2023 in the International Journal of Behavioural Nutrition and Physical Activity: https://ijbnpa.biomedcentral.com/articles/10.1186/s12966-023-01431-3
Phase 2 (Knowledge User Perceptions – Older Adults): Too little attention has been directed to ensuring that randomized controlled trials of physical activity interventions for older adults are measuring patient-relevant outcomes. Thus, to support outcome selection for future trials and the development of a core outcome set, the objective of this study was to understand what outcomes related to their physical activity participation older adults find important. We conducted 12 semi-structured interviews with adults aged 65 to 95 years and analyzed interview transcripts with a reflexive thematic analysis. We found that older adults desired diverse outcomes from their physical activity participation, ranging from generic (e.g., quality of life) to specific (e.g., leg strength). Relevant outcomes were classified under five themes: physical, clinical, social, psychological, and overarching, each with respective subthemes. The outcomes of physical activity participation that older adults found important were plentiful and rooted in a deep desire to improve their quality of life. Some of the outcome themes that are important to older adults have been reported frequently in past trials (e.g., physical), but others have not (e.g., social, emotional). Future researchers should be aware of, and responsive to, the priorities of older adults when designing trials and defining outcomes. This study was published in 2024 in the Journal of Aging and Physical Activity: https://journals.humankinetics.com/view/journals/japa/32/5/article-p624.xml?content=supplementary-materials
Phase 3 (Knowledge User Perceptions – Health Care Professionals): Health care professionals can play a pivotal role in promoting physical activity to older adults. Yet, prescription of physical activity is frequently neglected by many health care professionals. If outcomes that are relevant to health care professionals were routinely measured in research trials, it could aid in their willingness, ability, and desire to promote physical activity in their practice. Therefore, it is essential to incorporate priorities of health care professionals in the development of a core outcome set. The aim of this study is to determine what outcomes associated with older adult physical activity participation key health care professionals who work with older adults deem most important. To determine health care professional priorities, we are recruiting general practitioner/family physicians, physiotherapists, and kinesiologists from British Columbia, Canada to complete a brief web-based survey.
Phase 4 (Consensus Generation): In this phase we will convene an expert panel comprised of physical activity researchers/clinical trialists/systematic reviewers, health care professionals (e.g., Physiotherapists, Kinesiologists), and older adults. The panel will participate in a modified, multi-round, Delphi study to generate consensus on which outcome domain to include in a core outcome set for randomized controlled trials of physical activity interventions for older adults. We will provide panelists with evidence summaries from Phases 1, 2, and 3 of this project to help inform their ratings of candidate outcome domains.