Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frailty, and Sarcopenia in Older Adults From the Municipality of Santoña: a Quasi-experimental Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Short Physical Performance Battery (SPPB) score
研究概览
简要总结
This study evaluates the effects of a community-based multicomponent exercise program on physical function, frailty, and sarcopenia in older adults living in the municipality of Santoña (Cantabria, Spain). The exercise program is organized and delivered by the Santoña Town Council as part of its public health services for older residents and is not created for research purposes; it will continue regardless of the outcome of this study. Researchers are only evaluating participants who voluntarily agree to be assessed before and after each 36-week cycle of the program, over four consecutive academic years (2026-2030). The main question this study aims to answer is whether continued participation in this real-world, community-based multicomponent exercise program (based on the Vivifrail model) leads to meaningful improvements in physical function, muscle strength, and cardiorespiratory capacity, and helps reverse indicators of frailty and sarcopenia in independent, community-dwelling older adults. Participants will complete functional and physical tests, including balance, gait speed, chair-stand performance, handgrip strength, and a 6-minute walk test, at the start and end of each 36-week exercise cycle. No blood or biological samples will be collected.
详细描述
Most of the existing evidence on the benefits of multicomponent exercise for reversing frailty and sarcopenia in older adults comes from lab-based clinical trials conducted in highly controlled hospital or laboratory settings. While these studies have strong internal validity, they often lack ecological validity, meaning they do not reflect the real-world conditions, barriers, and adherence dynamics of community-based programs. There is therefore a public health need to evaluate whether the efficacy demonstrated in controlled settings translates into real, sustainable effectiveness when delivered through existing municipal, real-world programs.
This study evaluates a pre-existing, independently run community exercise program organized by the Santoña Town Council (Cantabria, Spain) for older adults referred through local health centers. The program has been running for several years and will continue to be delivered by the Town Council regardless of this study's outcome. The scope of this research is limited to the scientific evaluation of participants' physical and functional status before and after their participation in the program; the research team has no role in designing, modifying, or delivering the exercise intervention itself.
Design: This is a quasi-experimental, single-group, repeated-measures (pre-post) study. A passive control group was not included, as the community health-promotion nature of the program makes it inappropriate to withhold access to exercise and its benefits from eligible older residents. Each participant serves as their own control, comparing baseline and post-intervention measures.
Intervention being evaluated: The municipal exercise program follows a 36-week multicomponent format addressing strength, balance, endurance, and flexibility, structured according to the FITT-VP principles of the Vivifrail model (Izquierdo, 2019). Sessions are supervised by qualified exercise professionals who individualize training loads. The research team is not modifying this program in any way; researchers are solely adding an assessment protocol before and after each 36-week cycle.
Recruitment and timeframe: Recruitment will take place annually over four consecutive academic years (2026/2027 to 2029/2030), with an estimated 60 participants recruited per cohort, for a cumulative total of approximately 240 participants across the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age 65 years or older
- •Independent, community-dwelling (not institutionalized)
- •Barthel Index score ≥ 90 points (no significant disability)
- •Timed Up and Go (TUG) test ≥ 10 seconds
- •Short Physical Performance Battery (SPPB) score below 12 points (indicating possible frailty)
- •Fall risk indicated by at least one of the following: one fall in the past year requiring assistance, more than one fall without assistance, TUG > 20 seconds, or gait speed over 6 meters > 7.50 seconds
- •Reduced grip strength: below 27 kg (men) or below 16 kg (women), or more than 15 seconds to complete 5 chair stands
- •Voluntary signed informed consent
排除标准
- •Terminal illness
- •Residing in a nursing home
- •Diagnosed with, or under investigation for, moderate to severe cognitive impairment
- •Unstable cardiovascular disease
- •Acute infectious disease
- •Uncontrolled hypertension (systolic > 180 mmHg or diastolic > 110 mmHg)
- •Uncontrolled diabetes
- •Advanced organ failure
- •Disabling musculoskeletal condition
研究组 & 干预措施
Community Multicomponent Exercise Program
Participants aged 65 and older meeting the inclusion criteria take part in the pre-existing 36-week multicomponent exercise program delivered by the Santoña Town Council. Functional and physical assessments are performed at baseline (week 0) and at the end of each 36-week cycle (week 36), across four consecutive academic years. Each participant serves as their own control.
干预措施: Multicomponent Exercise Program (Vivifrail-based) (Behavioral)
结局指标
主要结局
Short Physical Performance Battery (SPPB) score
时间窗: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Composite score assessing lower-extremity physical function through three components - standing balance, 4-meter gait speed, and time to complete five repeated chair stands. Total score ranges from 0 to 12, with lower scores indicating greater physical frailty.
次要结局
- Handgrip strength(Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030))
- 30-Second Chair Stand Test(Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030))
- 6-Minute Walk Test (6MWT) distance(Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030))
- Body weight and Body Mass Index (BMI)(Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030))
- Waist circumference(Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030))
- Self-perceived fitness (International Fitness Scale, IFIS)(Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030))
研究者
JAVIER FERNÁNDEZ-ORTEGA
Andrés B. Fernández-Revelles, Principal Investigator, Associate Professor; Javier Fernández-Ortega, PhD Student
Universidad de Granada