Exercise in Adults with Post-Acute Sequelae of SARS-CoV-2 (COVID-19) Infection Study

Purpose

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.

Condition

  • COVID-19

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Other: Exercise Prescription
    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.
Sham Comparator
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.
  • Other: Exercise Prescription
    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.

Recruiting Locations

More Details

NCT ID
NCT05218174
Status
Completed
Sponsor
Baylor Research Institute

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).