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

NCT05218174 | Completed

• 1 other identifier: 021-347
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (9)

• Peak Oxygen Consumption (VO2max), mL/min

  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.

  At first assessment, during week 1.

• Peak Oxygen Consumption (VO2max), mL/min

  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.

  At second assessment, during week 11.

• Peak Oxygen Consumption (VO2max), mL/min

  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.

  At third assessment, during week 20.

• Score on Cognitive Function Self-Assessment Scale (CFSS)

  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.

  At first assessment, during week 1.

• Score on Cognitive Function Self-Assessment Scale (CFSS)

  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.

  At second assessment, during week 11.

• Score on Cognitive Function Self-Assessment Scale (CFSS)

  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.

  At third assessment, during week 20.

• Score on PHQ-8

  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.

  At first assessment, during week 1.

• Score on PHQ-8

  The Patient Health Questionnaire (PHQ-8) is an 8-item self-report questionnaire assessing the participant for depression. Each question uses a 4-point Likert scale and the score is determined by the sum of the 8 numbers with higher scores indicating a more severe depression.

  At second assessment, during week 11.

• Score on PHQ-8

  The Patient Health Questionnaire (PHQ-8) is an 8-item self-report questionnaire assessing the participant for depression. Each question uses a 4-point Likert scale and the score is determined by the sum of the 8 numbers with higher scores indicating a more severe depression.

  At third assessment, during week 20.

Secondary Outcomes (115)

• Duration, mm:ss

  At first assessment, during week 1.

• Duration, mm:ss

  At second assessment, during week 11.

• Duration, mm:ss

  At third assessment, during week 20.

• Peak VO2 (absolute), mL/min

  At first assessment, during week 1.

• Peak VO2 (absolute), mL/min

  At second assessment, during week 11.

Study Arms (2)

Exercise training program

EXPERIMENTAL

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

No training program

SHAM COMPARATOR

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

Interventions

Exercise Prescription 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.

Exercise training program; No training program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Self-reported history of COVID-19 diagnosis
• Self-reported ongoing symptoms of PASC \>4 weeks after initial infection

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead
• Sports Academy: collaborator

Study Sites (1)

Baylor Scott and White Sports Therapy and Research

Frisco, Texas, 75034, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Center Director - The STAR at Frisco

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: February 1, 2022
• Study Start: April 22, 2022
• Primary Completion: November 17, 2023
• Study Completion: December 29, 2023
• Last Updated: January 22, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)