COMPASS 65+ - Community-based Physical Activity Snacks for Healthy Aging in Overweight and Obese Aged Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Recruitment Rate (Reach)
研究概览
简要总结
This study will explore a new way for older adults to become more physically active. As people get older, it's common to gain weight and lose muscle strength. This combination can make it harder to do daily activities, increase the risk of falls, and impact overall quality of life. While we know that regular exercise is very beneficial, many older adults find it difficult to stick to traditional exercise programs due to lack of time, motivation, or energy.
This research project, called COMPASS 65+, will test an innovative approach called "snack exercise." Instead of one long workout, "snack exercise" involves doing several short bouts of activity, a few minutes at a time, throughout the day. The main idea is that these short, frequent bouts of activity might be easier to fit into a daily routine and less tiring than longer exercise sessions.
The purpose of this study is to see if a "snack exercise" program is a feasible and enjoyable way for adults aged 65 and over, who are overweight or obese, to improve their health. The study will be conducted in two main parts. First, the research team will talk with older adults to understand what helps or hinders them from being active to co-design the program. Second, volunteers will be randomly assigned to either a "snack exercise" group or a control group.
Participants in the "snack exercise" group will attend sessions that combine theory and practice to learn how to perform these exercises and will receive individualized prescriptions to perform the "snacks" (short bouts) at home. The control group will receive a brief educational counselling session on physical activity. Participants' health status, body composition, and physical fitness will be assessed at baseline, after the 12 weeks intervention, and again 6 weeks post-intervention to evaluate the maintenance of any improvements. These outcomes will help determine whether short bouts of 'exercise snacking' constitute a feasible and effective strategy to promote functional capacity, metabolic health, and long-term adherence to physical activity.
详细描述
Study Rationale and Background The intersection of an aging population and the obesity epidemic poses a significant public health challenge, particularly for adults aged 65 and older. This combination often leads to sarcopenic obesity, a condition characterized by excess body fat and low muscle mass and strength, which substantially increases the risk of falls, frailty, functional decline, and loss of independence. While physical activity is a proven non-pharmacological intervention to counteract these declines, adherence to traditional, structured exercise programs remains low among older adults. Barriers such as a perceived lack of time, low motivation, and fatigue create a gap between the known benefits of exercise and its practical implementation in real-world community settings.
This study, COMPASS 65+, proposes to evaluate an innovative exercise modality known as "snack exercise." This approach involves short, frequent bouts of physical activity performed throughout the day, designed to be more accessible and less burdensome than conventional exercise routines. The primary aim of this project is to assess the feasibility, acceptability, and preliminary effects of a community-based "snack exercise" program, co-designed with input from the target population, for overweight and obese older adults. The findings are intended to provide the necessary evidence to design a future, definitive large-scale randomized controlled trial (RCT).
Study Design
The research plan is structured in two sequential phases:
- Phase 1: Exploratory Mixed-Methods Study This initial phase is designed to inform the development of the intervention. It involves a mixed-methods approach to identify barriers, facilitators, and preferences related to physical activity among the target population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults aged ≥65 years with a BMI ≥25 kg/m².
排除标准
- •significant cognitive deficits,
- •contraindications to exercise (assessed via PAR-Q+),
- •major cardiovascular events within the last 3 months,
- •unstable chronic disease,
- •severe mobility impairment.
结局指标
主要结局
Recruitment Rate (Reach)
时间窗: From the start of recruitment until the target sample size is reached (approximately 2 months).
The percentage of eligible individuals who consent to participate in the study out of all individuals invited. This will be a measure of the reach and appeal of the intervention and study design.
Adherence to the "Snack Exercise" Program (Effectiveness)
时间窗: Throughout the 12-week intervention period.
The percentage of scheduled "snack exercise" sessions attended by participants in the intervention group. Adherence will be calculated as (number of sessions attended / total number of scheduled sessions) x 100. This measures the effectiveness of the program in engaging participants.
Program Implementation Fidelity (Implementation)
时间窗: Throughout the 12-week intervention period.
The degree to which the "snack exercise" program is delivered as intended by the study protocol. This will be assessed by a checklist monitoring staff adherence to the protocol, including session content, duration, and intensity monitoring procedures. It will be measured as a percentage of protocol items successfully delivered.
Participant Retention Rate
时间窗: From baseline (T0) to the final follow-up assessment (T2) at 18 weeks.
The percentage of enrolled participants who complete all study assessments at all time points (T0, T1, and T2). This measures the overall acceptability of the study procedures and the ability to retain participants over the full duration.
Intention to Continue Exercise (Maintenance)
时间窗: At the final follow-up assessment (T2) at 18 weeks.
Assessed via a self-report questionnaire administered at the final follow-up visit, evaluating participants' intention and confidence to continue with "snack exercise" or other forms of physical activity independently after the study concludes.
次要结局
- Multidimensional Lifestyle and Health Status(Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).)
- Daily Physical Activity Patterns(Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).)
- Body Composition - Dual-Energy X-ray Absorptiometry (DEXA)(Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).)
- Anthropometrics - Height(Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).)
- Anthropometrics - Weight(Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).)
- Anthropometrics - Body Mass Index (BMI)(Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).)
- Anthropometrics - Waist circumference(Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).)
- Cardiorespiratory Fitness(Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).)
- Functional Fitness (muscular endurance)(Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).)
- Functional Fitness and Fall risk - Short Physical Performance Battery (SPPB)(Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).)
- Fall Risk and Functional stability (force platform)(Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).)
- Exercise Self-Efficacy (ESES)(Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).)
研究者
Susana Miguel
MSc, MD, PhD candidate
University of Coimbra