Effectiveness of a Multi-component Physical Exercise Online on Physical Performance in Community-dwelling Older Adults: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Physical performance
研究概览
简要总结
Objective: to assess the effectiveness of a multi-component physical exercise online intervention (MPE) on physical performance (PP) in community-dwelling older adults.
Methods: a randomized controlled trial, including 110 older adults (68.45±5.54 years), were divided into two parallel groups: an MPE group (n = 55) and a control group (n = 55). The exercise program included endurance, strength, coordination, balance, and flexibility exercises which were carried out for 3 months. The control group received educational sessions on health prevention related to physical exercise. The main endpoint was a change in PP assessed with the short physical performance battery (SPPB). It is also evaluated other variables such as sociodemographic (sex, age, education level), health conditions (cognitive impairment, polypharmacy, comorbidity, frailty, sarcopenia, depressive and anxiety symptoms), functional dependence through scales of activities of daily living (ADL), nutrition (risk of malnutrition, weight, height, body mass index (BMI), calf and waist circumference) and lifestyles (physical activity, alcoholism, and smoking). Comparisons were made in the follow-up measurements between groups by an independent t-test and baseline and follow-up measurements in both groups by a paired t-test.
详细描述
Methods Study design and participants. The study was a randomized controlled trial conducted from June to October 2021. The study population was randomly selected from the FraDySMex study (Frailty, Dynapenia and Sarcopenia in Mexican Adults), adults aged 50 years and older. The adults were residents of Mexico City from three different municipalities (Cuajimalpa, Álvaro Obregón and Magdalena Contreras). The protocol was approved by the Committee on Ethics in Research of the "Iberoamerican University, Mexico City. with No35/2020. Informed consent was obtained from each participant who signed it after fully understanding the procedures.
The eligibility criteria were the following:
- Adults 60 and over years
- Adults who had an electronic device with internet access for video calls.
The exclusion criteria were:
- Adults self-reported walking disability, with the inability to complete the short physical performance battery (SPPB)
- Adults with severe functional dependence (defined as a Barthel index ≤ 60/100 score)
- Adults with cognitive impairment (defined as a mini-mental state examination (MMSE) score <24/30)
- Adults with terminal illness
- Adults who were participation in a physical activity or nutritional program
- Adults with a limb loss or use of lower or upper limb prostheses
- Adults with a history of injuries (fractures/falls) of less than one year in hip, knee or ankle joints and with surgery in the last 6 months or contraindications to perform trial activities in the judgment of medical personnel.
- Adults who presented any medical condition or adverse symptoms during the intervention that made it impossible to carry out the physical exercise program
- Adults who did not keep three times consecutive were eliminated from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria were the following:
- •Adults 60 and over years
- •Adults who had an electronic device with internet access for video calls.
排除标准
- •Adults self-reported walking disability, with the inability to complete the short physical performance battery (SPPB)
- •Adults with severe functional dependence (defined as a Barthel index ≤ 60/100 score)
- •Adults with cognitive impairment (defined as a mini-mental state examination (MMSE) score <24/30)
- •Adults with terminal illness
- •Adults who were participating in a physical activity or nutritional program
- •Adults with a limb loss or use of lower or upper limb prostheses
- •Adults with a history of injuries (fractures/falls) of less than one year in hip, knee or ankle joints and with surgery in the last 6 months or contraindications to perform trial activities in the judgment of medical personnel.
- •Adults who presented any medical condition or adverse symptoms during the intervention that made it impossible to carry out the physical exercise program
- •Adults who did not keep three times consecutive were eliminated from the study.
结局指标
主要结局
Physical performance
时间窗: 3 months
Physical performance was assessed with an short battery physical performance which is an instrument that evaluates three domains of physical performance: balance, gait speed, and lower limb strength to rise from a chair.
次要结局
未报告次要终点