Effects of Face-to-face and Video-assisted Physical Exercise Sessions on Frailty, Mental and Physical Health of Older Adults in Rural Areas.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Frailty status.
研究概览
简要总结
Global aging is a significant challenge, both economically and in terms of public health. One of the main challenges is to maintain the health and functionality of older adults. Physical exercise has been suggested as one of the best non-pharmacological tools to prevent health and functionality loss. However, existing scientific literature has mainly focused on older adults from urban centers. There are no studies focused on older people in rural areas, who have particular characteristics.
The present project aims to evaluate the effects of a face-to-face and video-assisted intervention, which incorporates multi-component physical exercise with different motivational strategies, on the mental health, physical function, and frailty of individuals over 65 years of age residing in rural areas. Additionally, it aims to determine the effectiveness, safety, and adherence of new technologies in carrying out an intervention that includes multi-component physical exercise, cognitive work, and motivational strategies through video assistance for older women and men living in rural areas.
A randomized controlled trial will be conducted, involving 240 people over the age of 65 who will be randomly divided into two groups. One group, the intervention group, will participate in a face-to-face multicomponent physical exercise program three times a week for 60 minutes per session over 12 weeks. After that, the intervention will continue through video-assisted sessions for the remaining nine months, divided into three blocks of two months of rest and one video-assisted intervention. The control group will continue with their usual daily activities but receive recommendations for physical activity and mental and physical health talks. Both groups will undergo a battery of tests to evaluate the effects of the interventions. The primary variable measured will be functional capacity, assessed through the Short Physical Performance Battery. Secondary variables will include health-related physical condition (Power frail app), cognitive function (Trail making test), and quality of life, among others.
The results expected from this study will be of significant scientific and technical importance in the field of psycho-socio-health. Consequently, the project is of utmost importance, not only to enhance the health of the rural population but also to promote individual and social sustainability.
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 (Outcomes Assessor)
盲法说明
The statistician will only have codes but in the database but will not know which code corresponds to which group
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age equal to or greater than 65 years.
- •Be able to provide informed consent voluntarily.
- •Walk autonomously.
- •Have a score of 4 points or more on the Short Physical Performance Battery (SPPB).
排除标准
- •Those that have to do with contraindications for performing physical exercise:
- •Recent acute myocardial infarction within the last 3-6 months or unstable angina.
- •Uncontrolled atrial or ventricular arrhythmias.
- •Dissecting aortic aneurysm.
- •Severe aortic stenosis.
- •Acute endocarditis or pericarditis.
- •Uncontrolled arterial hypertension (>180/100 mmHg).
- •Acute thromboembolic disease.
- •Acute and severe heart or respiratory failure.
- •Recent bone fracture, orthostatic hypotension.
- •Diabetes or uncontrolled hypoglycemia.
- •Any pathology that causes a significant functional limitation such as advanced Parkinson's, considerable vision or hearing problems Cancer, or autoimmune disease.
- •People scoring less than 4 on the SPPB (dependents).
- •Any pathology or circumstance that the primary care team considers counterproductive to participation in physical exercise.
研究组 & 干预措施
Intervention group
Participants will undergo a face-to-face and video-assisted physical exercise intervention.
干预措施: Face-to-face and video-assisted training (Device)
Control group
Participants in the control group will maintain their usual lifestyle throughout the project. They will receive physical activity recommendations for older people and will attend monthly health promotion meetings.
结局指标
主要结局
Frailty status.
时间窗: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
Frailty status measured with the Short Physical Performance Battery (SPPB). The minimum value is 0 and the maximum value is 12 points. A score of \< 10 points means frailty. Therefore, a higher score means a better outcome.
次要结局
- Frailty.(T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.)
- Mental health and depression.(T0 = pre-intervention, T1 = 3 months, and T4 = 12 months)
- Walking steps.(T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.)
- Muscular strength of the upper limbs.(T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.)
- Objective physical activity levels (minutes and intensities)(T0 = pre-intervention, T1 = 3 months, and T4 = 12 months)
- The Aging Self-Efficacy Scale.(T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.)
- Walking speed.(T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.)
- Body composition - Fat mass and Fat-Free mass.(T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.)
- Cognitive impairment.(T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.)
- Muscular strength of the lower limbs.(T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.)
- Aerobic capacity.(T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.)
- SARC-F Questionnaire.(T0 = pre-intervention, T1 = 3 months, and T4 = 12 months)
- Power Frail App.(T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.)
- Quality of life of participants EuroQol-5D.(T0 = pre-intervention, T1 = 3 months, and T4 = 12 months)
- Trail Making Test (TMT).(T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.)
- DeJong Gierveld Loneliness Scale.(T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.)
- Walking distance.(T0 = pre-intervention, T1 = 3 months, and T4 = 12 months)
- Physical activity levels(T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.)
研究者
Ángel Matute-Llorente
Principal Investigator
Universidad de Zaragoza