Exercise Training and Functional, Cognitive, and Emotional Well-being in Adults with Post-Acute Sequelae of SARS-CoV-2 (COVID-19) Infection (PASC): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Score on PHQ-8
研究概览
简要总结
To examine the efficacy of an 8-week exercise training program on functional, cognitive, and emotional health outcomes compared to a no treatment control condition in adults with PASC.
详细描述
Conduct a randomized control trial with a wait-list control to examine the efficacy of an 8-week exercise training program on functional, cognitive, and emotional health outcomes compared to a no treatment control condition in adults with PASC.
Examine participant compliance (in-person attendance, online engagement) with the 8-week exercise training program including in-person exercise sessions, cognitive performance training, and virtual exercise sessions delivered via a mobile application.
To determine if compliance with the 8-week exercise training program is associated with improvement in functional, cognitive, and emotional health outcomes.
Determine if there is a maintenance effect for individuals randomized into the 8-week exercise training program by comparing their outcomes at the end of the 8-week training exercise program to their outcomes at the end of their trial participation (16 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years of age
- •Self-reported history of COVID-19 diagnosis
- •Self-reported ongoing symptoms of PASC >4 weeks after initial infection
排除标准
- •Neuromotor, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise or conditions preventing cooperation
- •COVID-19 infection occurring > 6 months prior to screening date
- •Contraindications to Symptom-limited Maximal Exercise Testing
- •Individuals without access to a device with iOS (apple devices such as iPhone, iPad, MacBook, etc.)
- •Patient-reported diagnosis of severe arterial hypertension
- •Patient reported metabolic disease
- •Patient reported uncontrolled asthma
- •Pregnancy
- •Patient reported supplemental O2 use
- •Presence of beards
- •Patient reported diagnosis of claustrophobia
- •Non-English speaking
结局指标
主要结局
Score on PHQ-8
时间窗: At third assessment, during week 20.
The Patient Health Questionnaire (PHQ-8) is an 8-item self-report questionnaire assessing the participant for depression. Each question uses a 4-point Likert scale and the score is determined by the sum of the 8 numbers with higher scores indicating a more severe depression.
Peak Oxygen Consumption (VO2max), mL/min
时间窗: At third assessment, during week 20.
Peak oxygen consumption (VO2max) is an indicator of health and fitness. Participants will perform a cardiopulmonary exercise test (CPET) while a metabolic cart measures and calculates their VO2max.
Score on Cognitive Function Self-Assessment Scale (CFSS)
时间窗: At third assessment, during week 20.
The Cognitive Function Self-Assessment Scale (CFSS) is an 18-item questionnaire designed to self-assess cognitive function. Each question uses a 5-point Likert scale ranging from "never" (0) to "always" (5). The total score is calculated from the mean of the numbers with a lower values indicating a better self-perception of cognitive function and higher values indicating a worse self-perception of cognitive function.
次要结局
- Duration, mm:ss(At third assessment, during week 20.)
- Peak VO2 (relative), mL/kg/min(At third assessment, during week 20.)
- VE/VCO2 slope(At third assessment, during week 20.)
- Tidal Volume, L(At third assessment, during week 20.)
- Heart Rate, bpm(At third assessment, during week 20.)
- Heart Rate Reserve, bpm(At third assessment, during week 20.)
- VO2 at anaerobic threshold, mL/min(At third assessment, during week 20.)
- PetO2, mmHg(At third assessment, during week 20.)
- Heart Rate Variability (HRV)(Lasting 26 weeks.)
- Skin temperature, °F(Lasting 26 weeks.)
- Metabolic Equivalents(At third assessment, during week 20.)
- Respiratory Exchange Ratio(At third assessment, during week 20.)
- Minute Ventilation, L/min(At third assessment, during week 20.)
- Breathing Reserve, %(At third assessment, during week 20.)
- Heart Rate Recovery at 1 min, bpm(At third assessment, during week 20.)
- Pulse oximetry(At third assessment, during week 20.)
- Rhythm on electrocardiogram(At third assessment, during week 20.)
- Peak VO2 (absolute), mL/min(At third assessment, during week 20.)
- Respiratory Frequency, /min(At third assessment, during week 20.)
- PetCO2, mmHg(At third assessment, during week 20.)
- Self-Rated Dyspnea(At third assessment, during week 20.)
- Respiratory rate(Lasting 26 weeks.)
- Dexterity on CogPT app(At third assessment, during week 20.)
- Sleep efficiency on WHOOP(Lasting 26 weeks.)
- Sleep duration on WHOOP(Lasting 26 weeks.)
- VO2/Heart Rate, mL/beat(At third assessment, during week 20.)
- VE/VCO2(At third assessment, during week 20.)
- Strain(Lasting 26 weeks.)
- Motor Speed on CogPT app(At third assessment, during week 20.)
- Reaction Time on CogPT app(At third assessment, during week 20.)
- Inhibition on CogPT app(At third assessment, during week 20.)
- Dual-Processing on CogPT app(At third assessment, during week 20.)
- Working Memory Capacity(At third assessment, during week 20.)
- Posttraumatic growth (PTGI)(At third assessment, during week 20.)
- Self-Rated Perceived Exertion(At third assessment, during week 20.)
- IPAQ(At third assessment, during week 20.)
- Sleep stage duration on WHOOP(Lasting 26 weeks.)
- PTSD (LEC-5 and PCL-5)(At third assessment, during week 20.)
- Reaction Time with No-Go on CogPT app(At third assessment, during week 20.)
- Patient-Reported Outcomes Measurement Information System (PROMIS)(At third assessment, during week 20.)
- Health Related Quality of Life (EQ-5D)(At third assessment, during week 20.)
- Anxiety (GAD-7)(At third assessment, during week 20.)
- Breathlessness (mMRC)(At third assessment, during week 20.)
研究者
Simon Driver
Research Center Director - The STAR at Frisco
Baylor Research Institute