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

Baylor Scott and White Health (BSWH)

Status: Completed

Conditions: COVID-19

Treatments: Other: Exercise Prescription

Study type: Interventional

Funder types: Other

Identifiers

NCT05218174

021-347

Details and patient eligibility

About

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.

Full 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).

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

21 participants in 2 patient groups

Exercise training program

Experimental group

Description:

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.

Treatment:

Other: Exercise Prescription

No training program

Sham Comparator group

Description:

Participants in this arm will be wearing the WHOOP band for 8-weeks but will not be exposed to any active intervention.

Treatment:

Other: Exercise Prescription