Effects of a Remote Physical Training Program Combined With Cognitive Training in Older Adults at Increased Risk of Clinical-functional Vulnerability: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Dual-task performance
研究概览
简要总结
This study is a randomized, single-blind, parallel, controlled, superiority trial. The main objective is to verify the chronic effects of a remote 12-week low-intensity physical training program alone or in combination with cognitive training on functional, cognitive, and occupational capacity, as well as on the self-reported quality of life.
详细描述
Participants over 60 years of age at increased risk of clinical-functional vulnerability will be recruited in the city of Pelotas/RS, Brazil and randomized to two different arms. The intervention group will receive low-intensity physical training combined with a cognitive training program using neurobic exercises, whereas the active comparator group will only receive the low-intensity physical training program. Participants from both groups will perform their training sessions remotely for a total of 12 weeks. Outcomes of interest include handgrip strength, functional and cognitive capacity, occupational performance, clinical-functional vulnerability level, self-reported quality of life, and depressive symptoms, which will be assessed in a pre-post fashion. The study hypothesis is that remote low-intensity physical training combined with cognitive training will result in additional benefits to those of low-intensity physical training alone in the physical and cognitive capacity outcomes, and as a consequence, improved quality of life, occupational performance, decreased level of clinical-functional vulnerability and symptoms of depression will be observed.
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
Blinding will be implemented for the outcome assessors. Specifically, all tests, assessments, and measurements will be performed by an investigator blinded to the group participants were assigned to. Because of the type of intervention (i.e., exercise intervention), the investigator(s) who will carry out the exercise sessions, as well as the participants, won't be blinded.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •60 years of age or older,
- •MMSE score equal to or greater than 19 points,
- •Elementary school education complete or over,
- •Sedentary (no current or previous participation in structured exercise (>1x/week) in the past 6 months),
- •Increased risk of clinical-functional vulnerability, as determined by the Clinical-Functional Vulnerability Index-20 (IVCF-20) questionnaire.
- •Access to a cell phone or notebook with internet access,
- •Resident in the city of Pelotas, Brazil.
排除标准
- •Individuals who have been affected by COVID-19,
- •Not retired, or those retired individuals who maintained continuous or sporadic work activities,
- •Neuromuscular deficits or any medical diagnosis that prevents the individuals from performing physical exercises,
- •Individuals with decompensated or untreated blood pressure (> than 140x90 mmHg) and,
- •Individuals with visual problems that prevent them from watching the training sessions on their cell phone or notebook screen.
结局指标
主要结局
Dual-task performance
时间窗: Baseline (weeks 0) to Post-training (week 13)
The TUG test will also be applied with a dual task, in which participants' functional capacity will be assessed while simultaneously performing a verbal task. Specifically, the participants will perform the same procedures explained in the TUG test session, while also pronouncing the maximal number of animal names as possible.
Timed Up and Go (TUG) performance
时间窗: Baseline (weeks 0) to Post-training (week 13)
The TUG test will be used to measure possible modifications in the dynamic balance of older adults during the performance of the task.
Mini-Mental State Examination (MMSE) score
时间窗: Baseline (weeks 0) to Post-training (week 13)
The MMSE will be used to assess participants' cognitive function, which will be classified based on the education-adjusted cut-off scores.
次要结局
- Beck's Depression Inventory (BDI) score(Baseline (weeks 0) to Post-training (week 13))
- Canadian Occupational Performance Measure (COPM)(Baseline (weeks 0) to Post-training (week 13))
- Digit Span Test (DST)(Baseline (weeks 0) to Post-training (week 13))
- 30-s Sit-to-Stand test performance(Baseline (weeks 0) to Post-training (week 13))
- Verbal fluency test(Baseline (weeks 0) to Post-training (week 13))
- Handgrip strength(Baseline (weeks 0) to Post-training (week 13))
- World Health Organization Quality of Life-bref (WHOQOL-bref) score(Baseline (weeks 0) to Post-training (week 13))
研究者
Cristine Lima Alberton
Principal investigator
Federal University of Pelotas