Impact of Functional and Cognitive Rehabilitation, in Adults With Chronic Noncommunicable Diseases and Long Covid-19 , on Their Functional and Cognitive Capacity, Quality of Life, and the Evolution of Their Baseline Condition, in Bogotá D.C.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 374
- 试验地点
- 2
- 主要终点
- Composite Change in Functional Capacity, Cognitive Function, Health-Related Quality of Life, and Strength
研究概览
简要总结
This study aims to evaluate the impact of a functional and cognitive rehabilitation strategy compared to evidence-based informational messages, on functional capacity, cognitive abilities, quality of life, and disease progression in adults with chronic non-communicable diseases (NCDs) and Long Covid-19.
Researchers will compare a structured rehabilitation program to informational support through evidence-based messages to determine if rehabilitation leads to better functional and cognitive outcomes in patients with Long Covid-19.
Participants will be randomly assigned to one of two groups:
- Functional and cognitive rehabilitation: Attending weekly in-person sessions for 8 weeks, including supervised physical and cognitive exercises.
- Informational support: Receiving weekly evidence-based educational messages for 8 weeks.
Participants will undergo assessments at baseline, post-intervention, and six months later, including a six-minute walk test, handgrip strength measurement, and questionnaires on disability, anxiety, depression, fatigue, dyspnea, cognitive function, and quality of life.
详细描述
Study Objective
The primary goal of this study is to evaluate the impact of a functional and cognitive rehabilitation strategy compared to evidence-based informational messages, on functional capacity, cognitive abilities, quality of life, and disease progression in adults with chronic non-communicable diseases (NCDs) and Long Covid-19.
Specific Objectives
- Determine the prevalence of Long Covid-19 among participants from previous Covid-19 institutional registries, describing the primary clinical manifestations based on symptom recurrence and severity.
- Administer a functional and cognitive rehabilitation strategy in patients with NCDs and Long Covid-19, and compare it with evidence-based informational messages
Evaluate the impact of both interventions on key clinical outcomes, including:
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Covid-19 confirmed.
- •History of arterial hypertension or diabetes mellitus before entering the institutional registries of the FCI-IC or HOMIL, institutional registries of the FCI-IC or HOMIL or before having the diagnosis of SARSCoV-2 infection.
- •Persistence of two or more concurrent symptoms, related to Covid-19 prologue, for at least 4 weeks (persistent, intermittent, or intermittent).
- •At least one of these symptoms must have an impact on activities of daily living. They can be physical (fatigue, dyspnea, myalgias, arthralgias) or neuropsychiatric (cognitive, sleep and emotional alterations).
- •Symptoms unexplained by underlying disease or other condition concomitant with SARS-CoV-2 infection. SARS-CoV-2 infection (determined by prior medical history review and participant interview).
- •participant interview).
- •- Ability to read and attend functional and cognitive rehabilitation sessions or to receive the with evidence-based informational messages.
排除标准
- •Age >80 years.
- •Severely advanced baseline comorbidities prior to SARS-CoV-2 infection.
- •Presence of chronic respiratory disease (partial or permanent supplemental oxygen use), cardiac failure (LVEF<40%) or advanced renal disease (GFR<30%).
- •heart failure (LVEF<40%) or advanced renal disease (GFR<30).
- •Two hospitalizations in the year prior to admission to the institutional registries of the FCI-IC and the HOMIL for the patient's underlying disease.
- •Dependence on a caregiver.
- •Orthopedic or cardiopulmonary problems that contraindicate the performance of aerobic exercise.
- •Neuropsychiatric or cognitive limitations that limit understanding or following commands and performing attention exercises.
研究组 & 干预措施
Functional and Cognitive Rehabilitation
Participants assigned to the functional and cognitive rehabilitation strategy will attend one weekly session for 8 weeks at study sites. Each session includes one hour of functional rehabilitation (warm-up, aerobic exercise, muscle strengthening, and cool-down) supervised by healthcare professionals who monitor effort levels and heart rate. Additionally, participants will receive 30 minutes of cognitive rehabilitation, focusing on memory, attention, and executive functions, guided by occupational therapists or speech therapists. This intervention aims to enhance physical and cognitive function in patients with chronic diseases and Long Covid-19.
干预措施: Evidence-Based Informational Support (Other)
Evidence-Based Informational Support
Participants assigned to the evidence-based informational support arm will receive weekly educational messages for 8 weeks via email or text messages. These messages are derived from a thorough review of high-quality scientific studies and cover key topics related to Covid-19 prevention, treatment, follow-up, and prognosis. A total of 24 informational pieces will be delivered, ensuring patients receive clear, research-based guidance to support their health management. This intervention aims to improve patient awareness and self-care strategies for Long Covid-19 and chronic conditions.
干预措施: Functional and cognitive rehabilitation strategy (Other)
结局指标
主要结局
Composite Change in Functional Capacity, Cognitive Function, Health-Related Quality of Life, and Strength
时间窗: Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.
The primary outcome is a composite measure evaluating the aggregated change across four key functional and cognitive scales: * Functional Capacity with six-minute walk test. * Cognitive Function with Montreal Cognitive Assessment, MoCA. The minimum score is 0 points, which would indicate very severe cognitive impairment, since the maximum total score is 30 points. Normally, a score of 26 or higher is considered within the normal range, although the range may vary depending on factors such as the patient's age and educational level. A score below 26 could suggest possible cognitive impairment, and the lower the score, the more indicative it may be of severe cognitive problems. * Health-Related Quality of Life with EuroQol 5 Dimensions 5 Levels, EQ-5D-5L. Maximum value: 1 This value corresponds to the best possible health state. Minimum value: -0.594 This value corresponds to the worst possible. * Handgrip Strength with hydraulic dynamometer.
次要结局
- Change in Functional Capacity(Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.)
- Change in Cognitive Function(Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.)
- Change in Health-Related Quality of Life(Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.)
- Change in Health-Related Quality of Life, Visual Analogue Scale(Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.)
- Change in Handgrip Strength, Hydraulic Dynamometer(Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.)
- Incidence of Chronic Disease Decompensation Events(Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.)
- Additional Functional and Clinical Assessments(Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.)