A Pilot and Feasibility Study of a Web-based Platform to Improve Physical Function, Nutrition, and Mindfulness in Patients With Long COVID
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Feasibility (defined by recruitment, adherence, and retention).
研究概览
简要总结
Patients with COVID-19 may experience prolonged physical and psychological symptoms after weeks or months of the infection. This may be caused by a combination of factors including poor nutrition, low physical activity, and lack of emotional support. Leading to poor overall health and low quality of life. This evidence indicated that people with long COVID-19 need a personalized intervention. Our objective is to determine if the use of an online application that is based on preventive self-care and that includes nutrition and mindfulness will be feasible to use for patients with long COVID.
详细描述
A Canadian web-based platform called My Viva Plan® became available. This web-based platform is based on preventive self-care and it includes three key pillars of health: nutrition and mindfulness.
Long COVID patients will be randomized into the following two groups; intervention arm (will use a web-based platform for 8 weeks) vs. control arm (will not use a web-based platform for 8 weeks).The primary aim of this study is to investigate the feasibility (defined by recruitment, adherence, and retention) of an 8-week digital nutrition and mindfulness self-care intervention program using My Viva Plan® versus usual care (i.e. general advice) in patients with long COVID who continue to have signs and symptoms not explainable by other causes. Dietary intake, physical function, body composition and mental health variables will also be explored.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years.
- •COVID diagnosed (PCR positivity) >12 weeks at time of screening and have persistent symptoms.
- •Body mass index (BMI) >18.5kg/m2 and < 35 kg/m
- •People with long COVID syndrome diagnosis enrolled in the Kaye Edmonton Clinic.
- •Have mild to moderate long COVID syndrome (Based on the Post COVID-19 Functional Status Scale from 0-3).
排除标准
- •Patients with severe mobility impairment (People without sufficiently mobile to come to the study centre).
- •Diagnosis of severe mental health disorders (e.g., depression, anxiety, eating disorders).
- •Individuals with pacemakers or other internal electrical medical devices.
- •Suffer from claustrophobia.
- •Pregnancy or lactation.
- •No internet access.
- •Not able to understand and communicate in English.
- •Major visual or hearing impairment or other serious illness that would preclude participation.
- •Living in assisted living situations or a nursing home.
- •Individuals who fell more than 3 times in the last month. Because of the risk of doing a physical activity unsupervised.
- •Not willing to make a change in their lifestyle (Readiness to change).
研究组 & 干预措施
Control Arm
No use of My Viva Plan
Intervention Arm
Use of My Viva Plan
干预措施: Web-based platform. (My Viva Plan) (Behavioral)
结局指标
主要结局
Feasibility (defined by recruitment, adherence, and retention).
时间窗: Baseline, week 8
The proportion of participants that agreed to participate, the engagement in the platform (login), participants who complete both visits
次要结局
- Changes in lean mass(Baseline, week 8)
- Changes in physical function(Baseline, week 8)
- Changes in fat mass(Baseline, week 8)
- Changes in dietary intake(Baseline, week 8)
- Changes in mindfulness with Mental health questionnaire from the Symptom Burden Questionnaire for Long COVID(Baseline, week 8)
- Changes in quality of life parameters(Baseline, week 8)
- Changes in muscle cross sectional area(Baseline, week 8)
- Changes in physical performance(Baseline, week 8)
- Changes in self-efficacy assessed with Patient-Reported Outcomes Measurement Information System(Baseline, week 8)
- Changes in physical activity (daily activities subscale) by the Symptom Burden Questionnaire for Long COVID.(Baseline, week 8)
- Changes in physical activity using the International Physical Activity Questionnaire(Baseline, week 8)
- Changes in resting energy expenditure(Baseline, week 8)