COVID-19
Conditions
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).
Interventions
In this prospective, randomized control trial, the investigators will compare functional exercise capacity, cognitive performance, and emotional well-being at baseline and following 2 conditions: (1) an 8-week exercise training program (intervention) or (2) no training program (control). Participants will be randomized using a 1:1 randomization scheme into either the intervention or control group. After 8 weeks, participants in the wait-list control group will begin the intervention for the next 8 weeks and activity undergone by participants first randomized into the intervention group will remain under observation.
Sponsors
Sports Academy
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 * Inmates * Pregnancy * Patient reported supplemental O2 use * Presence of beards * Patient reported diagnosis of claustrophobia * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Oxygen Consumption (VO2max), mL/min | 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. |
| Score on Cognitive Function Self-Assessment Scale (CFSS) | 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 PHQ-8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Equivalents | At first assessment, during week 1. | Using metabolic cart, metabolic equivalents will be recorded. |
| Respiratory Exchange Ratio | At first assessment, during week 1. | Using metabolic cart, respiratory exchange ratio will be recorded. |
| VE/VCO2 slope | At first assessment, during week 1. | Using metabolic cart, VE/VCO2 slope will be recorded. |
| Minute Ventilation, L/min | At first assessment, during week 1. | Using metabolic cart, minute ventilation will be recorded. |
| Breathing Reserve, % | At first assessment, during week 1. | Using metabolic cart, breathing reserve will be recorded. |
| Tidal Volume, L | At first assessment, during week 1. | Using metabolic cart, tidal volume will be recorded. |
| Respiratory Frequency, /min | At first assessment, during week 1. | Using metabolic cart, respiratory frequency will be recorded. |
| Heart Rate, bpm | At first assessment, during week 1. | Using metabolic cart, heart rate will be recorded. |
| Heart Rate Reserve, bpm | At first assessment, during week 1. | Using metabolic cart, heart rate reserve will be recorded. |
| Heart Rate Recovery at 1 min, bpm | At first assessment, during week 1. | Using metabolic cart, heart rate recovery at 1 minute will be recorded. |
| VO2/Heart Rate, mL/beat | At first assessment, during week 1. | Using metabolic cart, VO2/heart rate will be recorded. |
| VO2 at anaerobic threshold, mL/min | At first assessment, during week 1. | Using metabolic cart, VO2 at anaerobic threshold will be recorded. |
| PetCO2, mmHg | At first assessment, during week 1. | Using metabolic cart, end-tidal carbon dioxide pressure (PetCO2) will be recorded. |
| PetO2, mmHg | At first assessment, during week 1. | Using metabolic cart, end-tidal oxygen pressure (PetO2) will be recorded. |
| VE/VCO2 | At first assessment, during week 1. | Using metabolic cart, minute ventilation/carbon dioxide production (VE/VCO2) will be recorded. |
| Self-Rated Perceived Exertion | At first assessment, during week 1. | 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. |
| Self-Rated Dyspnea | At first assessment, during week 1. | 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. |
| Pulse oximetry | At first assessment, during week 1. | 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 first assessment, during week 1. | Using an electrocardiogram, heart rhythm 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. |
| Respiratory rate | Lasting 26 weeks. | Using the WHOOP 4.0, respiratory rate will be recorded. This will be continuously recorded for 26 weeks. |
| Strain | Lasting 26 weeks. | Using the WHOOP 4.0, strain 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. |
| IPAQ | At first assessment, during week 1. | 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. |
| Motor Speed on CogPT app | At first assessment, during week 1. | Using the Sports Academy CogPT iPad application, motor speed will be recorded. |
| Reaction Time on CogPT app | At first assessment, during week 1. | Using the Sports Academy CogPT iPad application, reaction time will be recorded. |
| Reaction Time with No-Go on CogPT app | At first assessment, during week 1. | Using the Sports Academy CogPT iPad application, reaction time with no-go will be recorded. |
| Breathlessness (mMRC) | At first assessment, during week 1. | 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. |
| Dexterity on CogPT app | At first assessment, during week 1. | Using the Sports Academy CogPT iPad application, dexterity will be recorded. |
| Posttraumatic growth (PTGI) | At first assessment, during week 1. | 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. |
| Inhibition on CogPT app | At first assessment, during week 1. | Using the Sports Academy CogPT iPad application, inhibition will be recorded. |
| Dual-Processing on CogPT app | At first assessment, during week 1. | Using the Sports Academy CogPT iPad application, dual-processing will be recorded. |
| Working Memory Capacity | At first assessment, during week 1. | Using the Sports Academy CogPT iPad application, working memory capacity will be recorded. |
| 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. |
| 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 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. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) | At first assessment, during week 1. | 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. |
| Duration, mm:ss | At first assessment, during week 1. | Total time of test (CPET). |
| Anxiety (GAD-7) | At first assessment, during week 1. | 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. |
| PTSD (LEC-5 and PCL-5) | At first assessment, during week 1. | 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. |
| Health Related Quality of Life (EQ-5D) | At first assessment, during week 1. | 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. |
| Peak VO2 (absolute), mL/min | At first assessment, during week 1. | Using metabolic cart, absolute peak oxygen consumption will be recorded. |
| Peak VO2 (relative), mL/kg/min | At first assessment, during week 1. | Using metabolic cart, relative peak oxygen consumption will be recorded. |
Countries
United States
Outcome results
None listed