Covid19 Clinical Trial
— RECOVERYOfficial title:
Reconditioning Exercise for COVID-19 Patients Experiencing Residual sYmptoms
NCT number | NCT04958161 |
Other study ID # | IRB00075690 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2022 |
Est. completion date | May 2023 |
Verified date | July 2021 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Individuals who had COVID-19 and are thought to have recovered from the disease often experience long-term symptoms such as fatigue, extreme tiredness and shortness of breath, a condition referred to as Long COVID. Previous studies have shown that regular exercise is beneficial for individuals suffering similar symptoms as a result of other diseases such as Chronic Fatigue Syndrome. The goal of this study is determine if participation in a three-month structured exercise program will improve physical function in individuals suffering from Long COVID.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years and older |
Eligibility | Inclusion Criteria: - 55 years of age or older - Able to read and speak English - Proof of a positive nucleic acid amplification test for the determination of COVID-19 - Two months post positive nucleic acid amplification test for the determination of COVID - Self-report of COVID-19 symptoms (symptoms include any of the following: reduced exercise capacity, fatigue, cough, shortness of breath, headache and/or joint pain) - Able to understand and willing to sign a written informed consent document - Willing and able to complete all study procedures including attending all exercise sessions Exclusion Criteria: - Currently exercising more than 60 minutes per week at a moderate intensity or 30 minutes per week at a high intensity - Current use of supplemental oxygen - Active treatment for cancer - Severe congestive heart failure, pulmonary disease, stroke, peripheral vascular disease, coronary artery disease and/or valvular heart disease - Positive graded exercise test - Major psychiatric disease - Severe liver or hepatic disease - Uncontrolled hypertension or diabetes - Orthopedic impairment that prevents participation in an exercise program - Blindness - BMI > 40kg/m2 - Living more than 35 miles from exercise facility - Plans to move within the next 6 months |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Lung Volumes and Capacities | Nitrogen (N2) washout will be used to measure the various lung volumes and lung capacities according to American Thoracic Society and European Respiratory Society guidelines. | Baseline and Week 12 | |
Other | Air Flow | Air flow out of the lungs will be measured using spirometry. The forced expiratory volume in one second (FEV1) will be measured according to American Thoracic Society and European Respiratory Society guidelines. | Baseline and Week 12 | |
Other | Diffusion Capacity | Gas exchange will be used to measure the diffusion capacity of the lungs. All measures will be made according to American Thoracic Society and European Respiratory Society guidelines. | Baseline and Week 12 | |
Other | Respiratory Muscle Weakness | Maximum inspiratory strength and maximum expiratory strength will be used to determine respiratory muscle weakness. Maximum inspiratory strength and maximum expiratory strength will be measured as pressures at the mouth generated at residual volume and total lung capacity, respectively. All measures will be made according to American Thoracic Society and European Respiratory Society guidelines. | Baseline and Week 12 | |
Other | Exercise Capacity | Peak oxygen consumption (ml/kg/min) or aerobic capacity will be measured directly during a graded exercise test on an electronically braked cycle ergometer. | Baseline and Week 12 | |
Other | Cognitive Function | The Montreal Cognitive Assessment (MoCA) will be used to characterize global cognitive function. Scores range from 0 to 30, with a score of 26 and higher considered normal. | Baseline and Week 12 | |
Other | Generic Health Related Quality of Life (HRQL) - Physical Component | The SF-36 will be used as a generic measure of HRQL. The SF-36 consists of eight scales. Four of the eight scales will be used to produce a Physical Component score ranging from 0 -100 with lower scores indicative of poorer physical health. | Baseline and Week 12 | |
Other | Generic Health Related Quality of Life (HRQL) - Mental Component | The SF-36 will be used as a generic measure of HRQL. The SF-36 consists of eight scales. Four of the eight scales will be used to produce a Mental Component score ranging from 0 -100 score with lower scores indicative of poorer mental health. | Baseline and Week 12 | |
Other | Disease Specific Health Related Quality of Life (HRQL) | St. George's Respiratory Questionnaire (SGRQ) will be used as a disease specific measure of HRQL. SGRQ consists of three sub-scales. All three scales will be used to produce a score ranging from 0 - 100 score with lower scores indicative of a poorer health related quality of life. | Baseline and Week 12 | |
Other | Disability | The Functional Performance Inventory - Short Form (FPI-SF) will be used to assess disability. The FPI-SF queries participants about performance of activities of daily living to assess disability. Scores range from 0 to 3 with higher scores reflecting better functioning. | Baseline and Week 12 | |
Other | Fatigue | The Chalder Fatigue Score (CFQ-11) will be used to measure the severity of fatigue. Scores range from 0 to 33. Persons without fatigue problems would score 11 or lower. | Baseline and Week 12 | |
Primary | Performance Based Physical Function | Six minute walk distance will be used to measure performance based physical function. Subjects will walk at their chosen pace for six minutes on a pre-determined course. Total distance walked will be recorded. | Baseline | |
Primary | Performance Based Physical Function | Six minute walk distance will be used to measure performance based physical function. Subjects will walk at their chosen pace for six minutes on a pre-determined course. Total distance walked will be recorded. | Week 12 | |
Primary | Self-reported Physical Function | The Physical Functioning scale of the Medical Outcomes 36 Item Short Form (SF-36) will be used to measure self-reported physical function. Patient responses are rated on a on a 3-point scale (1- yes, limited a lot; 2 - yes, limited a little; or 3- no, not limited at all) and will then be normalized with a mean of 50 and standard deviation of 10. | Baseline | |
Primary | Self-reported Physical Function | The Physical Functioning scale of the Medical Outcomes 36 Item Short Form (SF-36) will be used to measure self-reported physical function. Patient responses are rated on a on a 3-point scale (1- yes, limited a lot; 2 - yes, limited a little; or 3- no, not limited at all) and will then be normalized with a mean of 50 and standard deviation of 10. | Week 12 | |
Secondary | Physical Function | Physical functioning will also be assessed using the Short Physical Performance Battery (SPPB). The SPPB score is based on timed measures of standing balance, walking speed, and ability to rise from a chair. Scores on each measure range from 0 - 4 and will be summed for a final score. Scores for the SPPB range from 0 to 12 with higher scores indicative of greater physical function. | Baseline and Week 12 |
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