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
- 1
- 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
研究组 & 干预措施
Exercise training program
Participants in this arm will complete an 8-week exercise training program comprised of an initial functional assessment to create an exercise prescription, followed by 7 in-person weekly sessions. Each session consisting of approximately 50 minutes of individualized exercise training and approximately 10 minutes of cognitive training via the Sports Academy "CogPT" iPad app. All participants will receive exercise and cognitive training delivered weekly in a group-based setting at Sports Academy within the Star in Frisco, Texas during the intervention period. Additionally, they will have access to daily workouts pushed to their phone via the MOVE exercise app developed by our team.
干预措施: Exercise Prescription (Other)
No training program
Participants in this arm will be wearing the WHOOP band for 8-weeks but will not be exposed to any active intervention.
干预措施: Exercise Prescription (Other)
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.
Peak Oxygen Consumption (VO2max), mL/min
时间窗: At first assessment, during week 1.
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.
Peak Oxygen Consumption (VO2max), mL/min
时间窗: At second assessment, during week 11.
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 first assessment, during week 1.
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.
Score on Cognitive Function Self-Assessment Scale (CFSS)
时间窗: At second assessment, during week 11.
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.
Score on PHQ-8
时间窗: At first assessment, during week 1.
The Patient Health Questionnaire (PHQ-8) is an 8-item self-report questionnaire assessing the participant for depression. Each question uses a 4-point scale and the score is determined by the sum of the 8 numbers with higher scores indicating a more severe depression.
Score on PHQ-8
时间窗: At second assessment, during week 11.
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.
次要结局
- 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.)
- Peak VO2 (absolute), mL/min(At third assessment, during week 20.)
- Patient-Reported Outcomes Measurement Information System (PROMIS)(At third assessment, during week 20.)
- 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.)
- Pulse oximetry(At third assessment, during week 20.)
- Rhythm on electrocardiogram(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.)
- 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.)
- Peak VO2 (relative), mL/kg/min(At first assessment, during week 1.)
- Duration, mm:ss(At first assessment, during week 1.)
- Duration, mm:ss(At second assessment, during week 11.)
- Peak VO2 (absolute), mL/min(At first assessment, during week 1.)
- Peak VO2 (absolute), mL/min(At second assessment, during week 11.)
- Peak VO2 (relative), mL/kg/min(At second assessment, during week 11.)
- Metabolic Equivalents(At first assessment, during week 1.)
- Metabolic Equivalents(At second assessment, during week 11.)
- Respiratory Exchange Ratio(At first assessment, during week 1.)
- Respiratory Exchange Ratio(At second assessment, during week 11.)
- VE/VCO2 slope(At first assessment, during week 1.)
- VE/VCO2 slope(At second assessment, during week 11.)
- Minute Ventilation, L/min(At first assessment, during week 1.)
- Minute Ventilation, L/min(At second assessment, during week 11.)
- Breathing Reserve, %(At first assessment, during week 1.)
- Breathing Reserve, %(At second assessment, during week 11.)
- Tidal Volume, L(At first assessment, during week 1.)
- Tidal Volume, L(At second assessment, during week 11.)
- Respiratory Frequency, /min(At first assessment, during week 1.)
- Respiratory Frequency, /min(At second assessment, during week 11.)
- Heart Rate, bpm(At first assessment, during week 1.)
- Heart Rate, bpm(At second assessment, during week 11.)
- Heart Rate Reserve, bpm(At first assessment, during week 1.)
- Heart Rate Reserve, bpm(At second assessment, during week 11.)
- Heart Rate Recovery at 1 min, bpm(At first assessment, during week 1.)
- Heart Rate Recovery at 1 min, bpm(At second assessment, during week 11.)
- VO2/Heart Rate, mL/beat(At first assessment, during week 1.)
- VO2/Heart Rate, mL/beat(At second assessment, during week 11.)
- VO2 at anaerobic threshold, mL/min(At first assessment, during week 1.)
- VO2 at anaerobic threshold, mL/min(At second assessment, during week 11.)
- PetCO2, mmHg(At first assessment, during week 1.)
- PetCO2, mmHg(At second assessment, during week 11.)
- PetO2, mmHg(At first assessment, during week 1.)
- PetO2, mmHg(At second assessment, during week 11.)
- VE/VCO2(At first assessment, during week 1.)
- VE/VCO2(At second assessment, during week 11.)
- Self-Rated Perceived Exertion(At first assessment, during week 1.)
- Self-Rated Perceived Exertion(At second assessment, during week 11.)
- Self-Rated Dyspnea(At first assessment, during week 1.)
- Self-Rated Dyspnea(At second assessment, during week 11.)
- Pulse oximetry(At first assessment, during week 1.)
- Pulse oximetry(At second assessment, during week 11.)
- Rhythm on electrocardiogram(At first assessment, during week 1.)
- Rhythm on electrocardiogram(At second assessment, during week 11.)
- IPAQ(At first assessment, during week 1.)
- IPAQ(At second assessment, during week 11.)
- Motor Speed on CogPT app(At first assessment, during week 1.)
- Motor Speed on CogPT app(At second assessment, during week 11.)
- Reaction Time on CogPT app(At first assessment, during week 1.)
- Reaction Time on CogPT app(At second assessment, during week 11.)
- Reaction Time with No-Go on CogPT app(At first assessment, during week 1.)
- Reaction Time with No-Go on CogPT app(At second assessment, during week 11.)
- Dexterity on CogPT app(At first assessment, during week 1.)
- Dexterity on CogPT app(At second assessment, during week 11.)
- Inhibition on CogPT app(At first assessment, during week 1.)
- Inhibition on CogPT app(At second assessment, during week 11.)
- Dual-Processing on CogPT app(At first assessment, during week 1.)
- Dual-Processing on CogPT app(At second assessment, during week 11.)
- Working Memory Capacity(At first assessment, during week 1.)
- Working Memory Capacity(At second assessment, during week 11.)
- Patient-Reported Outcomes Measurement Information System (PROMIS)(At first assessment, during week 1.)
- Patient-Reported Outcomes Measurement Information System (PROMIS)(At second assessment, during week 11.)
- Health Related Quality of Life (EQ-5D)(At first assessment, during week 1.)
- Health Related Quality of Life (EQ-5D)(At second assessment, during week 11.)
- Anxiety (GAD-7)(At first assessment, during week 1.)
- Anxiety (GAD-7)(At second assessment, during week 11.)
- PTSD (LEC-5 and PCL-5)(At first assessment, during week 1.)
- PTSD (LEC-5 and PCL-5)(At second assessment, during week 11.)
- Breathlessness (mMRC)(At first assessment, during week 1.)
- Breathlessness (mMRC)(At second assessment, during week 11.)
- Posttraumatic growth (PTGI)(At first assessment, during week 1.)
- Posttraumatic growth (PTGI)(At second assessment, during week 11.)
研究者
Simon Driver
Research Center Director - The STAR at Frisco
Baylor Research Institute