AzTrials
AzTrials

COVID-19PASCNCT05218174

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

A study testing Exercise Prescription in people with COVID-19, run by Baylor Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
COVID-19
What is being tested?
Exercise Prescription
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
1 siteUnited States
Study dates
22 Apr 2022to 29 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-65 years of age
  • Self-reported history of COVID-19 diagnosis
  • Self-reported ongoing symptoms of PASC >4 weeks after initial infection

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Baylor Scott and White Sports Therapy and Research

    Frisco, Texas, 75034

Other trials in United States

About this 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

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.

Read the 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
Being tested
Exercise Prescription
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise PrescriptionOther

    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.

Study groups in NCT05218174
Study groupRoleWhat they receive
Exercise training programExperimentalParticipants 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.
Receives: Other: Exercise Prescription
No training programSham comparatorParticipants in this arm will be wearing the WHOOP band for 8-weeks but will not be exposed to any active intervention.
Receives: Other: Exercise Prescription

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At first assessment, during week 1.

  2. 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.

    Measured: At second assessment, during week 11.

  3. 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.

    Measured: At third assessment, during week 20.

  4. 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.

    Measured: At first assessment, during week 1.

  5. 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.

    Measured: At second assessment, during week 11.

  6. 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.

    Measured: At third assessment, during week 20.

  7. 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.

    Measured: At first assessment, during week 1.

  8. 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.

    Measured: At second assessment, during week 11.

  9. 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.

    Measured: At third assessment, during week 20.

Secondary outcomes (115)

  1. Duration, mm:ss

    Total time of test (CPET).

    Measured: At first assessment, during week 1.

  2. Duration, mm:ss

    Total time of test (CPET).

    Measured: At second assessment, during week 11.

  3. Duration, mm:ss

    Total time of test (CPET).

    Measured: At third assessment, during week 20.

  4. Peak VO2 (absolute), mL/min

    Using metabolic cart, absolute peak oxygen consumption will be recorded.

    Measured: At first assessment, during week 1.

  5. Peak VO2 (absolute), mL/min

    Using metabolic cart, absolute peak oxygen consumption will be recorded.

    Measured: At second assessment, during week 11.

  6. Peak VO2 (absolute), mL/min

    Using metabolic cart, absolute peak oxygen consumption will be recorded.

    Measured: At third assessment, during week 20.

  7. Peak VO2 (relative), mL/kg/min

    Using metabolic cart, relative peak oxygen consumption will be recorded.

    Measured: At first assessment, during week 1.

  8. Peak VO2 (relative), mL/kg/min

    Using metabolic cart, relative peak oxygen consumption will be recorded.

    Measured: At second assessment, during week 11.

  9. Peak VO2 (relative), mL/kg/min

    Using metabolic cart, relative peak oxygen consumption will be recorded.

    Measured: At third assessment, during week 20.

  10. Metabolic Equivalents

    Using metabolic cart, metabolic equivalents will be recorded.

    Measured: At first assessment, during week 1.

  11. Metabolic Equivalents

    Using metabolic cart, metabolic equivalents will be recorded.

    Measured: At second assessment, during week 11.

  12. Metabolic Equivalents

    Using metabolic cart, metabolic equivalents will be recorded.

    Measured: At third assessment, during week 20.

  13. Respiratory Exchange Ratio

    Using metabolic cart, respiratory exchange ratio will be recorded.

    Measured: At first assessment, during week 1.

  14. Respiratory Exchange Ratio

    Using metabolic cart, respiratory exchange ratio will be recorded.

    Measured: At second assessment, during week 11.

  15. Respiratory Exchange Ratio

    Using metabolic cart, respiratory exchange ratio will be recorded.

    Measured: At third assessment, during week 20.

  16. VE/VCO2 slope

    Using metabolic cart, VE/VCO2 slope will be recorded.

    Measured: At first assessment, during week 1.

  17. VE/VCO2 slope

    Using metabolic cart, VE/VCO2 slope will be recorded.

    Measured: At second assessment, during week 11.

  18. VE/VCO2 slope

    Using metabolic cart, VE/VCO2 slope will be recorded.

    Measured: At third assessment, during week 20.

  19. Minute Ventilation, L/min

    Using metabolic cart, minute ventilation will be recorded.

    Measured: At first assessment, during week 1.

  20. Minute Ventilation, L/min

    Using metabolic cart, minute ventilation will be recorded.

    Measured: At second assessment, during week 11.

  21. Minute Ventilation, L/min

    Using metabolic cart, minute ventilation will be recorded.

    Measured: At third assessment, during week 20.

  22. Breathing Reserve, %

    Using metabolic cart, breathing reserve will be recorded.

    Measured: At first assessment, during week 1.

  23. Breathing Reserve, %

    Using metabolic cart, breathing reserve will be recorded.

    Measured: At second assessment, during week 11.

  24. Breathing Reserve, %

    Using metabolic cart, breathing reserve will be recorded.

    Measured: At third assessment, during week 20.

  25. Tidal Volume, L

    Using metabolic cart, tidal volume will be recorded.

    Measured: At first assessment, during week 1.

  26. Tidal Volume, L

    Using metabolic cart, tidal volume will be recorded.

    Measured: At second assessment, during week 11.

  27. Tidal Volume, L

    Using metabolic cart, tidal volume will be recorded.

    Measured: At third assessment, during week 20.

  28. Respiratory Frequency, /min

    Using metabolic cart, respiratory frequency will be recorded.

    Measured: At first assessment, during week 1.

  29. Respiratory Frequency, /min

    Using metabolic cart, respiratory frequency will be recorded.

    Measured: At second assessment, during week 11.

  30. Respiratory Frequency, /min

    Using metabolic cart, respiratory frequency will be recorded.

    Measured: At third assessment, during week 20.

  31. Heart Rate, bpm

    Using metabolic cart, heart rate will be recorded.

    Measured: At first assessment, during week 1.

  32. Heart Rate, bpm

    Using metabolic cart, heart rate will be recorded.

    Measured: At second assessment, during week 11.

  33. Heart Rate, bpm

    Using metabolic cart, heart rate will be recorded.

    Measured: At third assessment, during week 20.

  34. Heart Rate Reserve, bpm

    Using metabolic cart, heart rate reserve will be recorded.

    Measured: At first assessment, during week 1.

  35. Heart Rate Reserve, bpm

    Using metabolic cart, heart rate reserve will be recorded.

    Measured: At second assessment, during week 11.

  36. Heart Rate Reserve, bpm

    Using metabolic cart, heart rate reserve will be recorded.

    Measured: At third assessment, during week 20.

  37. Heart Rate Recovery at 1 min, bpm

    Using metabolic cart, heart rate recovery at 1 minute will be recorded.

    Measured: At first assessment, during week 1.

  38. Heart Rate Recovery at 1 min, bpm

    Using metabolic cart, heart rate recovery at 1 minute will be recorded.

    Measured: At second assessment, during week 11.

  39. Heart Rate Recovery at 1 min, bpm

    Using metabolic cart, heart rate recovery at 1 minute will be recorded.

    Measured: At third assessment, during week 20.

  40. VO2/Heart Rate, mL/beat

    Using metabolic cart, VO2/heart rate will be recorded.

    Measured: At first assessment, during week 1.

  41. VO2/Heart Rate, mL/beat

    Using metabolic cart, VO2/heart rate will be recorded.

    Measured: At second assessment, during week 11.

  42. VO2/Heart Rate, mL/beat

    Using metabolic cart, VO2/heart rate will be recorded.

    Measured: At third assessment, during week 20.

  43. VO2 at anaerobic threshold, mL/min

    Using metabolic cart, VO2 at anaerobic threshold will be recorded.

    Measured: At first assessment, during week 1.

  44. VO2 at anaerobic threshold, mL/min

    Using metabolic cart, VO2 at anaerobic threshold will be recorded.

    Measured: At second assessment, during week 11.

  45. VO2 at anaerobic threshold, mL/min

    Using metabolic cart, VO2 at anaerobic threshold will be recorded.

    Measured: At third assessment, during week 20.

  46. PetCO2, mmHg

    Using metabolic cart, end-tidal carbon dioxide pressure (PetCO2) will be recorded.

    Measured: At first assessment, during week 1.

  47. PetCO2, mmHg

    Using metabolic cart, end-tidal carbon dioxide pressure (PetCO2) will be recorded.

    Measured: At second assessment, during week 11.

  48. PetCO2, mmHg

    Using metabolic cart, end-tidal carbon dioxide pressure (PetCO2) will be recorded.

    Measured: At third assessment, during week 20.

  49. PetO2, mmHg

    Using metabolic cart, end-tidal oxygen pressure (PetO2) will be recorded.

    Measured: At first assessment, during week 1.

  50. PetO2, mmHg

    Using metabolic cart, end-tidal oxygen pressure (PetO2) will be recorded.

    Measured: At second assessment, during week 11.

  51. PetO2, mmHg

    Using metabolic cart, end-tidal oxygen pressure (PetO2) will be recorded.

    Measured: At third assessment, during week 20.

  52. VE/VCO2

    Using metabolic cart, minute ventilation/carbon dioxide production (VE/VCO2) will be recorded.

    Measured: At first assessment, during week 1.

  53. VE/VCO2

    Using metabolic cart, minute ventilation/carbon dioxide production (VE/VCO2) will be recorded.

    Measured: At second assessment, during week 11.

  54. VE/VCO2

    Using metabolic cart, minute ventilation/carbon dioxide production (VE/VCO2) will be recorded.

    Measured: At third assessment, during week 20.

  55. Self-Rated Perceived Exertion

    The Borg Rating of Perceived Exertion (6-20) scale will be used during the test to assess subjective exertion. Measured during each stage of the exercise protocol during the cardiopulmonary exercise test. Higher ratings indicating a higher level of exertion.

    Measured: At first assessment, during week 1.

  56. Self-Rated Perceived Exertion

    The Borg Rating of Perceived Exertion (6-20) scale will be used during the test to assess subjective exertion. Measured during each stage of the exercise protocol during the cardiopulmonary exercise test. Higher ratings indicating a higher level of exertion.

    Measured: At second assessment, during week 11.

  57. Self-Rated Perceived Exertion

    The Borg Rating of Perceived Exertion (6-20) scale will be used during the test to assess subjective exertion. Measured during each stage of the exercise protocol during the cardiopulmonary exercise test. Higher ratings indicating a higher level of exertion.

    Measured: At third assessment, during week 20.

  58. Self-Rated Dyspnea

    The Modified Borg Dyspnea Scale (0-10) will be used to assess subjective shortness of breath. Measured during each stage of the exercise protocol during the cardiopulmonary exercise test. Higher values indicating a higher degree of shortness of breath.

    Measured: At first assessment, during week 1.

  59. Self-Rated Dyspnea

    The Modified Borg Dyspnea Scale (0-10) will be used to assess subjective shortness of breath. Measured during each stage of the exercise protocol during the cardiopulmonary exercise test. Higher values indicating a higher degree of shortness of breath.

    Measured: At second assessment, during week 11.

  60. Self-Rated Dyspnea

    The Modified Borg Dyspnea Scale (0-10) will be used to assess subjective shortness of breath. Measured during each stage of the exercise protocol during the cardiopulmonary exercise test. Higher values indicating a higher degree of shortness of breath.

    Measured: At third assessment, during week 20.

  61. Pulse oximetry

    Measured by a pulse oximeter during each stage of the exercise protocol of the cardiopulmonary exercise test on a cycle ergometer.

    Measured: At first assessment, during week 1.

  62. Pulse oximetry

    Measured by a pulse oximeter during each stage of the exercise protocol of the cardiopulmonary exercise test on a cycle ergometer.

    Measured: At second assessment, during week 11.

  63. Pulse oximetry

    Measured by a pulse oximeter during each stage of the exercise protocol of the cardiopulmonary exercise test on a cycle ergometer.

    Measured: At third assessment, during week 20.

  64. Rhythm on electrocardiogram

    Using an electrocardiogram, heart rhythm will be recorded.

    Measured: At first assessment, during week 1.

  65. Rhythm on electrocardiogram

    Using an electrocardiogram, heart rhythm will be recorded.

    Measured: At second assessment, during week 11.

  66. Rhythm on electrocardiogram

    Using an electrocardiogram, heart rhythm will be recorded.

    Measured: At third assessment, during week 20.

  67. Heart Rate Variability (HRV)

    Using the WHOOP 4.0, heart rate variability (HRV) will be calculated and recorded. This will be continuously recorded for 26 weeks.

    Measured: Lasting 26 weeks.

  68. Respiratory rate

    Using the WHOOP 4.0, respiratory rate will be recorded. This will be continuously recorded for 26 weeks.

    Measured: Lasting 26 weeks.

  69. Strain

    Using the WHOOP 4.0, strain will be calculated and recorded. This will be continuously recorded for 26 weeks.

    Measured: Lasting 26 weeks.

  70. Skin temperature, °F

    Using the WHOOP 4.0, skin temperature will be recorded. This will be continuously recorded for 26 weeks.

    Measured: Lasting 26 weeks.

  71. IPAQ

    The International Physical Activity Questionnaire - Short Form (IPAQ-SF) is a 6-item questionnaire assessing how active an individual has been by asking about their activity history. Using the IPAQ, activity history will be recorded.

    Measured: At first assessment, during week 1.

  72. IPAQ

    The International Physical Activity Questionnaire - Short Form (IPAQ-SF) is a 6-item questionnaire assessing how active an individual has been by asking about their activity history. Using the IPAQ, activity history will be recorded.

    Measured: At second assessment, during week 11.

  73. IPAQ

    The International Physical Activity Questionnaire - Short Form (IPAQ-SF) is a 6-item questionnaire assessing how active an individual has been by asking about their activity history. Using the IPAQ, activity history will be recorded.

    Measured: At third assessment, during week 20.

  74. Motor Speed on CogPT app

    Using the Sports Academy CogPT iPad application, motor speed will be recorded.

    Measured: At first assessment, during week 1.

  75. Motor Speed on CogPT app

    Using the Sports Academy CogPT iPad application, motor speed will be recorded.

    Measured: At second assessment, during week 11.

  76. Motor Speed on CogPT app

    Using the Sports Academy CogPT iPad application, motor speed will be recorded.

    Measured: At third assessment, during week 20.

  77. Reaction Time on CogPT app

    Using the Sports Academy CogPT iPad application, reaction time will be recorded.

    Measured: At first assessment, during week 1.

  78. Reaction Time on CogPT app

    Using the Sports Academy CogPT iPad application, reaction time will be recorded.

    Measured: At second assessment, during week 11.

  79. Reaction Time on CogPT app

    Using the Sports Academy CogPT iPad application, reaction time will be recorded.

    Measured: At third assessment, during week 20.

  80. Reaction Time with No-Go on CogPT app

    Using the Sports Academy CogPT iPad application, reaction time with no-go will be recorded.

    Measured: At first assessment, during week 1.

  81. Reaction Time with No-Go on CogPT app

    Using the Sports Academy CogPT iPad application, reaction time with no-go will be recorded.

    Measured: At second assessment, during week 11.

  82. Reaction Time with No-Go on CogPT app

    Using the Sports Academy CogPT iPad application, reaction time with no-go will be recorded.

    Measured: At third assessment, during week 20.

  83. Dexterity on CogPT app

    Using the Sports Academy CogPT iPad application, dexterity will be recorded.

    Measured: At first assessment, during week 1.

  84. Dexterity on CogPT app

    Using the Sports Academy CogPT iPad application, dexterity will be recorded.

    Measured: At second assessment, during week 11.

  85. Dexterity on CogPT app

    Using the Sports Academy CogPT iPad application, dexterity will be recorded.

    Measured: At third assessment, during week 20.

  86. Inhibition on CogPT app

    Using the Sports Academy CogPT iPad application, inhibition will be recorded.

    Measured: At first assessment, during week 1.

  87. Inhibition on CogPT app

    Using the Sports Academy CogPT iPad application, inhibition will be recorded.

    Measured: At second assessment, during week 11.

  88. Inhibition on CogPT app

    Using the Sports Academy CogPT iPad application, inhibition will be recorded.

    Measured: At third assessment, during week 20.

  89. Dual-Processing on CogPT app

    Using the Sports Academy CogPT iPad application, dual-processing will be recorded.

    Measured: At first assessment, during week 1.

  90. Dual-Processing on CogPT app

    Using the Sports Academy CogPT application, dual-processing will be recorded.

    Measured: At second assessment, during week 11.

  91. Dual-Processing on CogPT app

    Using the Sports Academy CogPT iPad application, dual-processing will be recorded.

    Measured: At third assessment, during week 20.

  92. Working Memory Capacity

    Using the Sports Academy CogPT iPad application, working memory capacity will be recorded.

    Measured: At first assessment, during week 1.

  93. Working Memory Capacity

    Using the Sports Academy CogPT iPad application, working memory capacity will be recorded.

    Measured: At second assessment, during week 11.

  94. Working Memory Capacity

    Using the Sports Academy CogPT iPad application, working memory capacity will be recorded.

    Measured: At third assessment, during week 20.

  95. Sleep duration on WHOOP

    Using the WHOOP 4.0, sleep duration will be recorded. This will be continuously recorded every night for 26 weeks.

    Measured: Lasting 26 weeks.

  96. Sleep efficiency on WHOOP

    Using the WHOOP 4.0, sleep efficiency will be recorded. This will be continuously recorded every night for 26 weeks.

    Measured: Lasting 26 weeks.

  97. Sleep stage duration on WHOOP

    Using the WHOOP 4.0, sleep stage duration will be recorded. This will be continuously recorded every night for 26 weeks.

    Measured: Lasting 26 weeks.

  98. Patient-Reported Outcomes Measurement Information System (PROMIS)

    The Sleep Disturbance-Short Form 4a is derived from the Patient-Reported Outcomes Measurement Information System (PROMIS) and will be used to assess for adult sleep disturbance profiles. It consists of 4-items and is based on a 5-point scale. The sum of each response creates a total raw score. Higher total scores indicate a greater adult sleep disturbance profile. This measure is normed to the US general population.

    Measured: At first assessment, during week 1.

  99. Patient-Reported Outcomes Measurement Information System (PROMIS)

    The Sleep Disturbance-Short Form 4a is derived from the Patient-Reported Outcomes Measurement Information System (PROMIS) and will be used to assess for adult sleep disturbance profiles. It consists of 4-items and is based on a 5-point scale. The sum of each response creates a total raw score. Higher total scores indicate a greater adult sleep disturbance profile. This measure is normed to the US general population.

    Measured: At second assessment, during week 11.

  100. Patient-Reported Outcomes Measurement Information System (PROMIS)

    The Sleep Disturbance-Short Form 4a is derived from the Patient-Reported Outcomes Measurement Information System (PROMIS) and will be used to assess for adult sleep disturbance profiles. It consists of 4-items and is based on a 5-point scale. The sum of each response creates a total raw score. Higher total scores indicate a greater adult sleep disturbance profile. This measure is normed to the US general population.

    Measured: At third assessment, during week 20.

  101. Health Related Quality of Life (EQ-5D)

    Health Related Quality of Life will be assessed using the EuroQol (EQ-5D), a short questionnaire that covers mobility, self-care, activity, pain/discomfort, and anxiety/depression. This tool has shown to be valid, reliable, and responsive in a wide range of conditions and populations.

    Measured: At first assessment, during week 1.

  102. Health Related Quality of Life (EQ-5D)

    Health Related Quality of Life will be assessed using the EuroQol (EQ-5D), a short questionnaire that covers mobility, self-care, activity, pain/discomfort, and anxiety/depression. This tool has shown to be valid, reliable, and responsive in a wide range of conditions and populations.

    Measured: At second assessment, during week 11.

  103. Health Related Quality of Life (EQ-5D)

    Health Related Quality of Life will be assessed using the EuroQol (EQ-5D), a short questionnaire that covers mobility, self-care, activity, pain/discomfort, and anxiety/depression. This tool has shown to be valid, reliable, and responsive in a wide range of conditions and populations.

    Measured: At third assessment, during week 20.

  104. Anxiety (GAD-7)

    Anxiety will be measured using the General Anxiety Disorder-7 (GAD-7). It is a 7-item form, each of which is scored 0 to 3, yielding a 0 to 21 severity score. Higher scores indicating a more severe anxiety. The GAD-7 has shown to be valid, reliable, and sensitive in clinical practice and research.

    Measured: At first assessment, during week 1.

  105. Anxiety (GAD-7)

    Anxiety will be measured using the General Anxiety Disorder-7 (GAD-7). It is a 7-item form, each of which is scored 0 to 3, yielding a 0 to 21 severity score. Higher scores indicating a more severe anxiety. The GAD-7 has shown to be valid, reliable, and sensitive in clinical practice and research.

    Measured: At second assessment, during week 11.

  106. Anxiety (GAD-7)

    Anxiety will be measured using the General Anxiety Disorder-7 (GAD-7). It is a 7-item form, each of which is scored 0 to 3, yielding a 0 to 21 severity score. Higher scores indicating a more severe anxiety. The GAD-7 has shown to be valid, reliable, and sensitive in clinical practice and research.

    Measured: At third assessment, during week 20.

  107. PTSD (LEC-5 and PCL-5)

    Post-traumatic stress disorder (PTSD) symptom severity and trauma history will be assessed using two scales. The Life Events Checklist for DSM-5 (LEC-5) is a 17-item self-report measure designed to screen for traumatic life events. Participants will indicate varying levels of exposure to each type of potentially traumatic event included on a 6-point scale. Additionally, participants will complete the PTSD Check List (PCL-5), a 20-item self-report measure which yields a total symptom severity score of 0-80. Higher scores indicating a greater severity.

    Measured: At first assessment, during week 1.

  108. PTSD (LEC-5 and PCL-5)

    Post-traumatic stress disorder (PTSD) symptom severity and trauma history will be assessed using two scales. The Life Events Checklist for DSM-5 (LEC-5) is a 17-item self-report measure designed to screen for traumatic life events. Participants will indicate varying levels of exposure to each type of potentially traumatic event included on a 6-point scale. Additionally, participants will complete the PTSD Check List (PCL-5), a 20-item self-report measure which yields a total symptom severity score of 0-80. Higher scores indicating a greater severity.

    Measured: At second assessment, during week 11.

  109. PTSD (LEC-5 and PCL-5)

    Post-traumatic stress disorder (PTSD) symptom severity and trauma history will be assessed using two scales. The Life Events Checklist for DSM-5 (LEC-5) is a 17-item self-report measure designed to screen for traumatic life events. Participants will indicate varying levels of exposure to each type of potentially traumatic event included on a 6-point scale. Additionally, participants will complete the PTSD Check List (PCL-5), a 20-item self-report measure which yields a total symptom severity score of 0-80. Higher scores indicating a greater severity.

    Measured: At third assessment, during week 20.

  110. Breathlessness (mMRC)

    Breathlessness will be assessed using the Modified Medical Research Council Dyspnea Scale (mMRC) which is a self-report scale ranging from 0 to 4 commonly used to assess dyspnea during everyday life in patients with pulmonary disease. Higher values indicating a greater condition of dyspnea.

    Measured: At first assessment, during week 1.

  111. Breathlessness (mMRC)

    Breathlessness will be assessed using the Modified Medical Research Council Dyspnea Scale (mMRC) which is a self-report scale ranging from 0 to 4 commonly used to assess dyspnea during everyday life in patients with pulmonary disease. Higher values indicating a greater condition of dyspnea.

    Measured: At second assessment, during week 11.

  112. Breathlessness (mMRC)

    Breathlessness will be assessed using the Modified Medical Research Council Dyspnea Scale (mMRC) which is a self-report scale ranging from 0 to 4 commonly used to assess dyspnea during everyday life in patients with pulmonary disease. Higher values indicating a greater condition of dyspnea.

    Measured: At third assessment, during week 20.

  113. Posttraumatic growth (PTGI)

    Post-traumatic growth will be assessed by the Post-Traumatic Growth Inventory (PTGI), a 21-item scale with possible responses of 0 to 5 assessing positive outcomes after traumatic events. Numerical total score will be obtained and recorded with higher scores indicating a greater degree of change as a result of a crisis.

    Measured: At first assessment, during week 1.

  114. Posttraumatic growth (PTGI)

    Post-traumatic growth will be assessed by the Post-Traumatic Growth Inventory (PTGI), a 21-item scale with possible responses of 0 to 5 assessing positive outcomes after traumatic events. Numerical total score will be obtained and recorded with higher scores indicating a greater degree of change as a result of a crisis.

    Measured: At second assessment, during week 11.

  115. Posttraumatic growth (PTGI)

    Post-traumatic growth will be assessed by the Post-Traumatic Growth Inventory (PTGI), a 21-item scale with possible responses of 0 to 5 assessing positive outcomes after traumatic events. Numerical total score will be obtained and recorded with higher scores indicating a greater degree of change as a result of a crisis.

    Measured: At third assessment, during week 20.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2022
  2. Study start22 Apr 2022
  3. Primary completion17 Nov 2023
  4. Study completion29 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05218174
Sponsor's protocol ID
021-347
Acronym
PASC
Status last verified
Oct 2024
First submitted
22 Nov 2021
Last updated
22 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Prescription in people with COVID-19, run by Baylor Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Oxygen Consumption (VO2max), mL/min (time frame: At first assessment, during week 1.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05218174.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.

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