Clinical trial NCT05218174: Exercise in Adults with Post-Acute Sequelae of SARS-CoV-2 (COVID-19) Infection Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Sports Academy
First posted: 2022-02-01
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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
* Inmates
* Pregnancy
* Patient reported supplemental O2 use
* Presence of beards
* Patient reported diagnosis of claustrophobia
* Non-English speaking

Primary outcomes:
measure: Peak Oxygen Consumption (VO2max), mL/min
timeFrame: At first assessment, during week 1.
measure: Peak Oxygen Consumption (VO2max), mL/min
timeFrame: At second assessment, during week 11.
measure: Peak Oxygen Consumption (VO2max), mL/min
timeFrame: At third assessment, during week 20.
measure: Score on Cognitive Function Self-Assessment Scale (CFSS)
timeFrame: At first assessment, during week 1.
measure: Score on Cognitive Function Self-Assessment Scale (CFSS)
timeFrame: At second assessment, during week 11.
measure: Score on Cognitive Function Self-Assessment Scale (CFSS)
timeFrame: At third assessment, during week 20.
measure: Score on PHQ-8
timeFrame: At first assessment, during week 1.
measure: Score on PHQ-8
timeFrame: At second assessment, during week 11.
measure: Score on PHQ-8
timeFrame: At third assessment, during week 20.
Secondary outcomes:
measure: Duration, mm:ss
timeFrame: At first assessment, during week 1.
measure: Duration, mm:ss
timeFrame: At second assessment, during week 11.
measure: Duration, mm:ss
timeFrame: At third assessment, during week 20.
measure: Peak VO2 (absolute), mL/min
timeFrame: At first assessment, during week 1.
measure: Peak VO2 (absolute), mL/min
timeFrame: At second assessment, during week 11.
measure: Peak VO2 (absolute), mL/min
timeFrame: At third assessment, during week 20.
measure: Peak VO2 (relative), mL/kg/min
timeFrame: At first assessment, during week 1.
measure: Peak VO2 (relative), mL/kg/min
timeFrame: At second assessment, during week 11.
measure: Peak VO2 (relative), mL/kg/min
timeFrame: At third assessment, during week 20.
measure: Metabolic Equivalents
timeFrame: At first assessment, during week 1.
measure: Metabolic Equivalents
timeFrame: At second assessment, during week 11.
measure: Metabolic Equivalents
timeFrame: At third assessment, during week 20.
measure: Respiratory Exchange Ratio
timeFrame: At first assessment, during week 1.
measure: Respiratory Exchange Ratio
timeFrame: At second assessment, during week 11.
measure: Respiratory Exchange Ratio
timeFrame: At third assessment, during week 20.
measure: VE/VCO2 slope
timeFrame: At first assessment, during week 1.
measure: VE/VCO2 slope
timeFrame: At second assessment, during week 11.
measure: VE/VCO2 slope
timeFrame: At third assessment, during week 20.
measure: Minute Ventilation, L/min
timeFrame: At first assessment, during week 1.
measure: Minute Ventilation, L/min
timeFrame: At second assessment, during week 11.
measure: Minute Ventilation, L/min
timeFrame: At third assessment, during week 20.
measure: Breathing Reserve, %
timeFrame: At first assessment, during week 1.
measure: Breathing Reserve, %
timeFrame: At second assessment, during week 11.
measure: Breathing Reserve, %
timeFrame: At third assessment, during week 20.
measure: Tidal Volume, L
timeFrame: At first assessment, during week 1.
measure: Tidal Volume, L
timeFrame: At second assessment, during week 11.
measure: Tidal Volume, L
timeFrame: At third assessment, during week 20.
measure: Respiratory Frequency, /min
timeFrame: At first assessment, during week 1.
measure: Respiratory Frequency, /min
timeFrame: At second assessment, during week 11.
measure: Respiratory Frequency, /min
timeFrame: At third assessment, during week 20.
measure: Heart Rate, bpm
timeFrame: At first assessment, during week 1.
measure: Heart Rate, bpm
timeFrame: At second assessment, during week 11.
measure: Heart Rate, bpm
timeFrame: At third assessment, during week 20.
measure: Heart Rate Reserve, bpm
timeFrame: At first assessment, during week 1.
measure: Heart Rate Reserve, bpm
timeFrame: At second assessment, during week 11.
measure: Heart Rate Reserve, bpm
timeFrame: At third assessment, during week 20.
measure: Heart Rate Recovery at 1 min, bpm
timeFrame: At first assessment, during week 1.
measure: Heart Rate Recovery at 1 min, bpm
timeFrame: At second assessment, during week 11.
measure: Heart Rate Recovery at 1 min, bpm
timeFrame: At third assessment, during week 20.
measure: VO2/Heart Rate, mL/beat
timeFrame: At first assessment, during week 1.
measure: VO2/Heart Rate, mL/beat
timeFrame: At second assessment, during week 11.
measure: VO2/Heart Rate, mL/beat
timeFrame: At third assessment, during week 20.
measure: VO2 at anaerobic threshold, mL/min
timeFrame: At first assessment, during week 1.
measure: VO2 at anaerobic threshold, mL/min
timeFrame: At second assessment, during week 11.
measure: VO2 at anaerobic threshold, mL/min
timeFrame: At third assessment, during week 20.
measure: PetCO2, mmHg
timeFrame: At first assessment, during week 1.
measure: PetCO2, mmHg
timeFrame: At second assessment, during week 11.
measure: PetCO2, mmHg
timeFrame: At third assessment, during week 20.
measure: PetO2, mmHg
timeFrame: At first assessment, during week 1.
measure: PetO2, mmHg
timeFrame: At second assessment, during week 11.
measure: PetO2, mmHg
timeFrame: At third assessment, during week 20.
measure: VE/VCO2
timeFrame: At first assessment, during week 1.
measure: VE/VCO2
timeFrame: At second assessment, during week 11.
measure: VE/VCO2
timeFrame: At third assessment, during week 20.
measure: Self-Rated Perceived Exertion
timeFrame: At first assessment, during week 1.
measure: Self-Rated Perceived Exertion
timeFrame: At second assessment, during week 11.
measure: Self-Rated Perceived Exertion
timeFrame: At third assessment, during week 20.
measure: Self-Rated Dyspnea
timeFrame: At first assessment, during week 1.
measure: Self-Rated Dyspnea
timeFrame: At second assessment, during week 11.
measure: Self-Rated Dyspnea
timeFrame: At third assessment, during week 20.
measure: Pulse oximetry
timeFrame: At first assessment, during week 1.
measure: Pulse oximetry
timeFrame: At second assessment, during week 11.
measure: Pulse oximetry
timeFrame: At third assessment, during week 20.
measure: Rhythm on electrocardiogram
timeFrame: At first assessment, during week 1.
measure: Rhythm on electrocardiogram
timeFrame: At second assessment, during week 11.
measure: Rhythm on electrocardiogram
timeFrame: At third assessment, during week 20.
measure: Heart Rate Variability (HRV)
timeFrame: Lasting 26 weeks.
measure: Respiratory rate
timeFrame: Lasting 26 weeks.
measure: Strain
timeFrame: Lasting 26 weeks.
measure: Skin temperature, °F
timeFrame: Lasting 26 weeks.
measure: IPAQ
timeFrame: At first assessment, during week 1.
measure: IPAQ
timeFrame: At second assessment, during week 11.
measure: IPAQ
timeFrame: At third assessment, during week 20.
measure: Motor Speed on CogPT app
timeFrame: At first assessment, during week 1.
measure: Motor Speed on CogPT app
timeFrame: At second assessment, during week 11.
measure: Motor Speed on CogPT app
timeFrame: At third assessment, during week 20.
measure: Reaction Time on CogPT app
timeFrame: At first assessment, during week 1.
measure: Reaction Time on CogPT app
timeFrame: At second assessment, during week 11.
measure: Reaction Time on CogPT app
timeFrame: At third assessment, during week 20.
measure: Reaction Time with No-Go on CogPT app
timeFrame: At first assessment, during week 1.
measure: Reaction Time with No-Go on CogPT app
timeFrame: At second assessment, during week 11.
measure: Reaction Time with No-Go on CogPT app
timeFrame: At third assessment, during week 20.
measure: Dexterity on CogPT app
timeFrame: At first assessment, during week 1.
measure: Dexterity on CogPT app
timeFrame: At second assessment, during week 11.
measure: Dexterity on CogPT app
timeFrame: At third assessment, during week 20.
measure: Inhibition on CogPT app
timeFrame: At first assessment, during week 1.
measure: Inhibition on CogPT app
timeFrame: At second assessment, during week 11.
measure: Inhibition on CogPT app
timeFrame: At third assessment, during week 20.
measure: Dual-Processing on CogPT app
timeFrame: At first assessment, during week 1.
measure: Dual-Processing on CogPT app
timeFrame: At second assessment, during week 11.
measure: Dual-Processing on CogPT app
timeFrame: At third assessment, during week 20.
measure: Working Memory Capacity
timeFrame: At first assessment, during week 1.
measure: Working Memory Capacity
timeFrame: At second assessment, during week 11.
measure: Working Memory Capacity
timeFrame: At third assessment, during week 20.
measure: Sleep duration on WHOOP
timeFrame: Lasting 26 weeks.
measure: Sleep efficiency on WHOOP
timeFrame: Lasting 26 weeks.
measure: Sleep stage duration on WHOOP
timeFrame: Lasting 26 weeks.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: At first assessment, during week 1.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: At second assessment, during week 11.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: At third assessment, during week 20.
measure: Health Related Quality of Life (EQ-5D)
timeFrame: At first assessment, during week 1.
measure: Health Related Quality of Life (EQ-5D)
timeFrame: At second assessment, during week 11.
measure: Health Related Quality of Life (EQ-5D)
timeFrame: At third assessment, during week 20.
measure: Anxiety (GAD-7)
timeFrame: At first assessment, during week 1.
measure: Anxiety (GAD-7)
timeFrame: At second assessment, during week 11.
measure: Anxiety (GAD-7)
timeFrame: At third assessment, during week 20.
measure: PTSD (LEC-5 and PCL-5)
timeFrame: At first assessment, during week 1.
measure: PTSD (LEC-5 and PCL-5)
timeFrame: At second assessment, during week 11.
measure: PTSD (LEC-5 and PCL-5)
timeFrame: At third assessment, during week 20.
measure: Breathlessness (mMRC)
timeFrame: At first assessment, during week 1.
measure: Breathlessness (mMRC)
timeFrame: At second assessment, during week 11.
measure: Breathlessness (mMRC)
timeFrame: At third assessment, during week 20.
measure: Posttraumatic growth (PTGI)
timeFrame: At first assessment, during week 1.
measure: Posttraumatic growth (PTGI)
timeFrame: At second assessment, during week 11.
measure: Posttraumatic growth (PTGI)
timeFrame: At third assessment, during week 20.
Other outcomes:
Locations:
city: Frisco
country: United States
facility: Baylor Scott and White Sports Therapy and Research
state: Texas
Study officials:
References: