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

NCT ID: NCT05218174

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-22
• Study Completion Date: 2023-12-29

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).

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise Prescription

Intervention Type: OTHER

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.

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.

Group Type: SHAM_COMPARATOR

Exercise Prescription

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sports Academy

UNKNOWN

Sponsor Role: collaborator

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Simon Driver

Research Center Director - The STAR at Frisco

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baylor Scott and White Sports Therapy and Research

Frisco, Texas, United States

Countries

United States

Other Identifiers

021-347

Identifier Type: -

Identifier Source: org_study_id