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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Baylor Research Institute
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Score on PHQ-8
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
Simon Driver
Research Center Director - The STAR at Frisco
Baylor Research Institute
Eligibility Criteria
Inclusion Criteria
- •18-65 years of age
- •Self-reported history of COVID-19 diagnosis
- •Self-reported ongoing symptoms of PASC \>4 weeks after initial infection
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Score on PHQ-8
Time Frame: 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
Time Frame: 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)
Time Frame: 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 Outcomes
- 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.)