Impact of a Functional Gait Training Program as a Complementary Strategy to Improve Physical Function in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Physical Performance
研究概览
简要总结
The sequential square mat (SSM) Fisior® program is a novel functional gait training tool designed to enhance motor control, coordination, and strength through guided step sequences on a visual-tactile platform. The objective of the present study is to evaluate the effects of incorporating the SSM Fisior® gait training program into routine physical activity workshops for older adults. Specifically, the study aims to assess its impact on skeletal muscle quantity, strength, and performance, as well as overall functional capacity, in a population of older adults attending a municipal community center (Centro Integral del Adulto Mayor, CIAM) in Lima, Peru.
详细描述
The present study is a randomized was carried out with adults aged 60 years and older recruited from the Comprehensive Center for Older Adults (CIAM) in the Lince district of Lima, Peru. The study adhered to the ethical principles outlined in the Declaration of Helsinki, and its protocol (182-2023-CIEI-FMH-USMP) received approval from the Institutional Ethics Committee of the Faculty of Human Medicine at the University of San Martín de Porres (USMP), Lima, Peru.
Participants were eligible if they were 60 years or older, were not institutionalized, scored 24 or higher on the Mini-Mental State Examination (MMSE), indicating no cognitive impairment, could communicate effectively, were able to stand up and walk at least 10 meters unassisted, scored 60 or higher on the Barthel Index (indicating sufficient functional independence). Furthermore, participants were excluded if they had a medical condition that contraindicated gait training and exhibited severe cognitive or behavioral impairments that would prevent them from completing the training program.
A simple randomization process was used to assign participants to two groups: Group A and Group B. The randomization was performed using a computer-generated random number sequence with Microsoft Excel, and it was conducted after participant enrollment to ensure allocation concealment. Group A attended only the physical activity workshops offered by Centro Integral del Adulto Mayor (CIAM), consisting of one weekly class each of gymnastics, dance, swimming, and Tai Chi, held on different days of the week. Group B participated in the same workshops and additionally completed functional gait training using the SSM Fisior® program. The intervention period lasted 12 weeks for both groups, with 2 additional weeks allocated for baseline and post-intervention assessments (T1 and T2). All assessments and activities were carried out at the CIAM center in Lince (Lima, Peru), between October and December 2023.
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
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They where elegible if they were:
- •60 years or older.
- •Not institutionalized.
- •Scored 24 or higher on the Mini-Mental State Examination (MMSE), indicating no cognitive impairment.
- •Could communicate effectively.
- •Able to stand up and walk at least 10 meters unassisted
- •Scored 60 or higher on the Barthel Index (indicating sufficient functional independence).
排除标准
- •Furthermore, participants were excluded if they:
- •Had a medical condition that contraindicated gait training and exhibited severe cognitive or behavioral impairments that would prevent them from completing the training program.
结局指标
主要结局
Physical Performance
时间窗: Baseline and Week 12
Several tools have been proposed to evaluate mobility and to assess it. In this study, physical performance was measured using the Short Physical Performance Battery (SPPB), which has been validated for use in older populations. This test includes three components: balance (foot together, semi-tandem, tandem), 4-meter gait speed, and chair stand test (standing and sitting five times). The SPPB scores each timed task based on predefined thresholds, resulting in a total score ranging from 0 (worst performance) to 12 (best performance). The SPPB was designed to quickly identify the physical status of older adults by assessing lower limb functionality. Performance in these tests is strongly associated with mobility-related disability and serves as an independent predictor of short-term mortality and institutionalization. The medical community uses SPPB, among other tools, as a primary approach to detect and identifying frailty.
次要结局
- Gait Speed(Baseline and Week 12)
- Calf Circumference(Baseline and Week 12)
- Functional Capacity: Barthel Index(Baseline and Week 12)
- Gait Speed(Baseline and Week 12)
- Calf Circumference(Baseline and Week 12)
- Functional Capacity: Barthel Index(Baseline and Week 12)
- Abdominal Circumference(Baseline and Week 12)
- Handgrip Strength(Baseline and Week 12)
- SARC-F (Strength, Ambulation, Rising from a chair, Stair climbing and history of Falling)(Baseline and Week 12)
研究者
Alberto Bermejo Franco
Principal Investigator, Clinical Professor
Universidad Europea de Madrid