Exercise in Adults with Post-Acute Sequelae of SARS-CoV-2 (COVID-19) Infection Study
- Conditions
- COVID-19
- Interventions
- Other: Exercise Prescription
- Registration Number
- NCT05218174
- Lead Sponsor
- Baylor Research Institute
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- 18-65 years of age
- Self-reported history of COVID-19 diagnosis
- Self-reported ongoing symptoms of PASC >4 weeks after initial infection
- 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
- Inmates
- Pregnancy
- Patient reported supplemental O2 use
- Presence of beards
- Patient reported diagnosis of claustrophobia
- Non-English speaking
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description No training program Exercise Prescription Participants in this arm will be wearing the WHOOP band for 8-weeks but will not be exposed to any active intervention. Exercise training program Exercise Prescription 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.
- Primary Outcome Measures
Name Time Method Score on PHQ-8 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 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) 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.
- Secondary Outcome Measures
Name Time Method Duration, mm:ss At third assessment, during week 20. Total time of test (CPET).
Peak VO2 (relative), mL/kg/min At third assessment, during week 20. Using metabolic cart, relative peak oxygen consumption will be recorded.
VE/VCO2 slope At third assessment, during week 20. Using metabolic cart, VE/VCO2 slope will be recorded.
Heart Rate Reserve, bpm At third assessment, during week 20. Using metabolic cart, heart rate reserve will be recorded.
VO2 at anaerobic threshold, mL/min At third assessment, during week 20. Using metabolic cart, VO2 at anaerobic threshold will be recorded.
PetO2, mmHg At third assessment, during week 20. Using metabolic cart, end-tidal oxygen pressure (PetO2) will be recorded.
Heart Rate Variability (HRV) Lasting 26 weeks. Using the WHOOP 4.0, heart rate variability (HRV) will be calculated and recorded. This will be continuously recorded for 26 weeks.
Skin temperature, °F Lasting 26 weeks. Using the WHOOP 4.0, skin temperature will be recorded. This will be continuously recorded for 26 weeks.
Metabolic Equivalents At third assessment, during week 20. Using metabolic cart, metabolic equivalents will be recorded.
Respiratory Exchange Ratio At third assessment, during week 20. Using metabolic cart, respiratory exchange ratio will be recorded.
Minute Ventilation, L/min At third assessment, during week 20. Using metabolic cart, minute ventilation will be recorded.
Breathing Reserve, % At third assessment, during week 20. Using metabolic cart, breathing reserve will be recorded.
Heart Rate Recovery at 1 min, bpm At third assessment, during week 20. Using metabolic cart, heart rate recovery at 1 minute will be recorded.
Pulse oximetry At third assessment, during week 20. Measured by a pulse oximeter during each stage of the exercise protocol of the cardiopulmonary exercise test on a cycle ergometer.
Rhythm on electrocardiogram At third assessment, during week 20. Using an electrocardiogram, heart rhythm will be recorded.
Peak VO2 (absolute), mL/min At third assessment, during week 20. Using metabolic cart, absolute peak oxygen consumption will be recorded.
Respiratory Frequency, /min At third assessment, during week 20. Using metabolic cart, respiratory frequency will be recorded.
PetCO2, mmHg At third assessment, during week 20. Using metabolic cart, end-tidal carbon dioxide pressure (PetCO2) will be recorded.
Self-Rated Dyspnea At third assessment, during week 20. The Modified Borg Dyspnea Scale (0-10) will be used to assess subjective shortness of breath. Measured during each stage of the exercise protocol during the cardiopulmonary exercise test. Higher values indicating a higher degree of shortness of breath.
Respiratory rate Lasting 26 weeks. Using the WHOOP 4.0, respiratory rate will be recorded. This will be continuously recorded for 26 weeks.
Dexterity on CogPT app At third assessment, during week 20. Using the Sports Academy CogPT iPad application, dexterity will be recorded.
Sleep efficiency on WHOOP Lasting 26 weeks. Using the WHOOP 4.0, sleep efficiency will be recorded. This will be continuously recorded every night for 26 weeks.
Sleep duration on WHOOP Lasting 26 weeks. Using the WHOOP 4.0, sleep duration will be recorded. This will be continuously recorded every night for 26 weeks.
VO2/Heart Rate, mL/beat At third assessment, during week 20. Using metabolic cart, VO2/heart rate will be recorded.
VE/VCO2 At third assessment, during week 20. Using metabolic cart, minute ventilation/carbon dioxide production (VE/VCO2) will be recorded.
Strain Lasting 26 weeks. Using the WHOOP 4.0, strain will be calculated and recorded. This will be continuously recorded for 26 weeks.
Motor Speed on CogPT app At third assessment, during week 20. Using the Sports Academy CogPT iPad application, motor speed will be recorded.
Reaction Time on CogPT app At third assessment, during week 20. Using the Sports Academy CogPT iPad application, reaction time will be recorded.
Inhibition on CogPT app At third assessment, during week 20. Using the Sports Academy CogPT iPad application, inhibition will be recorded.
Dual-Processing on CogPT app At third assessment, during week 20. Using the Sports Academy CogPT iPad application, dual-processing will be recorded.
Working Memory Capacity At third assessment, during week 20. Using the Sports Academy CogPT iPad application, working memory capacity will be recorded.
Posttraumatic growth (PTGI) At third assessment, during week 20. Post-traumatic growth will be assessed by the Post-Traumatic Growth Inventory (PTGI), a 21-item scale with possible responses of 0 to 5 assessing positive outcomes after traumatic events. Numerical total score will be obtained and recorded with higher scores indicating a greater degree of change as a result of a crisis.
Self-Rated Perceived Exertion At third assessment, during week 20. The Borg Rating of Perceived Exertion (6-20) scale will be used during the test to assess subjective exertion. Measured during each stage of the exercise protocol during the cardiopulmonary exercise test. Higher ratings indicating a higher level of exertion.
IPAQ At third assessment, during week 20. The International Physical Activity Questionnaire - Short Form (IPAQ-SF) is a 6-item questionnaire assessing how active an individual has been by asking about their activity history. Using the IPAQ, activity history will be recorded.
Sleep stage duration on WHOOP Lasting 26 weeks. Using the WHOOP 4.0, sleep stage duration will be recorded. This will be continuously recorded every night for 26 weeks.
PTSD (LEC-5 and PCL-5) At third assessment, during week 20. Post-traumatic stress disorder (PTSD) symptom severity and trauma history will be assessed using two scales. The Life Events Checklist for DSM-5 (LEC-5) is a 17-item self-report measure designed to screen for traumatic life events. Participants will indicate varying levels of exposure to each type of potentially traumatic event included on a 6-point scale. Additionally, participants will complete the PTSD Check List (PCL-5), a 20-item self-report measure which yields a total symptom severity score of 0-80. Higher scores indicating a greater severity.
Reaction Time with No-Go on CogPT app At third assessment, during week 20. Using the Sports Academy CogPT iPad application, reaction time with no-go will be recorded.
Patient-Reported Outcomes Measurement Information System (PROMIS) At third assessment, during week 20. The Sleep Disturbance-Short Form 4a is derived from the Patient-Reported Outcomes Measurement Information System (PROMIS) and will be used to assess for adult sleep disturbance profiles. It consists of 4-items and is based on a 5-point scale. The sum of each response creates a total raw score. Higher total scores indicate a greater adult sleep disturbance profile. This measure is normed to the US general population.
Health Related Quality of Life (EQ-5D) At third assessment, during week 20. Health Related Quality of Life will be assessed using the EuroQol (EQ-5D), a short questionnaire that covers mobility, self-care, activity, pain/discomfort, and anxiety/depression. This tool has shown to be valid, reliable, and responsive in a wide range of conditions and populations.
Anxiety (GAD-7) At third assessment, during week 20. Anxiety will be measured using the General Anxiety Disorder-7 (GAD-7). It is a 7-item form, each of which is scored 0 to 3, yielding a 0 to 21 severity score. Higher scores indicating a more severe anxiety. The GAD-7 has shown to be valid, reliable, and sensitive in clinical practice and research.
Breathlessness (mMRC) At third assessment, during week 20. Breathlessness will be assessed using the Modified Medical Research Council Dyspnea Scale (mMRC) which is a self-report scale ranging from 0 to 4 commonly used to assess dyspnea during everyday life in patients with pulmonary disease. Higher values indicating a greater condition of dyspnea.
Tidal Volume, L At third assessment, during week 20. Using metabolic cart, tidal volume will be recorded.
Heart Rate, bpm At third assessment, during week 20. Using metabolic cart, heart rate will be recorded.
Trial Locations
- Locations (1)
Baylor Scott and White Sports Therapy and Research
🇺🇸Frisco, Texas, United States