Effectiveness of Non-invasive Brain Stimulation on Functional Capacity in Prefrail Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Frailty Condition
研究概览
简要总结
The general objective of this study is to evaluate the effectiveness of non-invasive neuromodulation combined with a therapeutic exercise program on neuroplasticity and, therefore, on variables related to functional capacity and quality of life, in prefrail older adults.
详细描述
Two non-invasive neuromodulation strategies (Virtual Running and Transcranial Direct Current Stimulation (tDCS)) will be studied. Thus, 2 sub-studies will be carried out (one for each intervention) and a comparison of the two interventions will be made, as described in the following sections. As specific objectives, for each of these sub-studies, the effect of the intervention program will be analyzed on: gait speed, general physical condition, frailty condition, static and dynamic functionality and gait quality, upper limb and lower limb isometric strength, quality of life, and neuroplasticity, in terms of plasma BDNF levels, in prefrail older adults.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 65 -90 years old
- •Meet 1-2 frailty criteria, according to Fried's Criteria.
- •Ability to understand instructions (Mini-Mental State Examination >23 points).
- •Signing of the informed consent.
排除标准
- •History of stroke within the past 6 months or hospital admission for any reason within the past 3 months.
- •Alterations of the central or peripheral nervous system
- •Alterations of the vestibular system
- •Concomitant diseases
- •Have a neurological pathology, cardiovascular musculoskeletal that contraindicates physical activity
- •Epilepsy or history, medications that lower the seizure threshold
- •Cardiac pacemaker, endocranial and hearing implants
- •History of severe headaches
- •Uncontrolled intracranial or arterial hypertension
- •Heart and/or respiratory failure
- •Implanted medication pump
- •Skin lesions (psoriasis, eczema)
- •Serious head surgeries
- •Completing less than 80% of training sessions
研究组 & 干预措施
rTMS placebo group
干预措施: rTMS placebo (Other)
tDCS placebo group
干预措施: tDCS placebo (Other)
VR group
干预措施: Virtual running (Other)
VR placebo group
干预措施: Virtual running placebo (Other)
rTMS group
干预措施: rTMS (Other)
tDCS group
干预措施: tDCS (Other)
结局指标
主要结局
Frailty Condition
时间窗: Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
Fried's criteria (Frailty Phenotype) will be used. Briefly, the participant will be considered frail if he or she meets three or more of the following criteria: i) unintentional weight loss greater than 4.5 kg in the last year; ii) feeling of general exhaustion, reported by the patient himself; iii) low level of physical activity; (iv) slowness of progress; v) muscle weakness, assessed by handgrip strength. Those patients who meet one or two criteria will be considered pre-frail and those who do not meet either will be considered non-frail
Walking speed
时间窗: Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
The 10m Walking Test will be used to assess the speed of the walk, which records the time needed to cover the distance of 10m. The higher the walking speed, the greater the functional capacity
次要结局
- Neuroplasticity(Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).)
- Heart rate variability(Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).)
- Muscle strength(Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).)
- Quality of life EQ-5D(Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).)
- Lower limb muscle power(Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).)
- Static and dynamic functionality and gait quality(Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).)
- Static and dynamic functionality and gait quality with a dual task(Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).)
研究者
Marta Inglés de la Torre
Professor
University of Valencia