Reconditioning Exercise for COVID-19 Patients Experiencing Residual sYmptoms

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
In December of 2019, a previously unknown betacoronavirus was discovered in the airways of patients with pneumonia in Wuhan, China. The novel coronavirus disease (COVID-19) caused by the virus (severe acute respiratory syndrome coronavirus (SARS-CoV-2)) spread rapidly around the world. Common symptoms include cough, fever, dyspnea (i.e. shortness of breath), musculoskeletal aches and pains and fatigue. These symptoms, most notably fatigue and dyspnea, have been reported months after the onset of the disease and often long after patients are thought to have recovered from the disease. Between one and two thirds of patients with milder forms of the disease report symptoms up to two months after the onset of symptoms. This condition is now referred to as Long COVID or Post- Acute Sequelae of SARS-CoV-2 infection, and the characteristic symptoms of this condition are dyspnea and extreme fatigue. Additionally, pulmonary, musculoskeletal, neurological, cardiac, and psychological sequelae in these survivors can affect their physical function and ability to perform activities of daily living. While exercise rehabilitation in patients recovering from COVID-19 has been cautiously recommended, there is little known about the response to exercise in patients with Long COVID-19 nor the optimal methods or strategies for rehabilitating these patients. Understanding the responses to an exercise program is instrumental in designing safe and effective rehabilitation strategies for these patients. The objective of this study is to examine the effect of a 3-month exercise therapy program on physical function in individuals who have recovered from COVID-19 between the previous 2 to 6 months, yet still report symptoms of the disease. The study is a randomized, wait-list-control pilot study designed to gather preliminary data. Participants will be randomized into one of two groups: an immediate treatment group or a wait-list-control group. The immediate treatment group will begin the exercise therapy program following randomization and will participate in the exercise program for a duration of three months. The wait-list-control group will receive usual care for the first three months, after which they will be allowed the opportunity to participate in the exercise therapy program for three months. Outcome measures will me made prior to randomization and following either the three-month exercise program or three months of usual care.

Official Title
-----------------
Reconditioning Exercise for COVID-19 Patients Experiencing Residual sYmptoms

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: Exercise Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Therapy<br>Exercise therapy will be performed three times per week for 12 weeks. | Other: Exercise Therapy<br>* Each exercise session will involve 5 to10 minutes of stretching and slow walking followed by a 30 minute stimulus phase of aerobic exercise. Exercise intensity during the stimulus phase will be prescribed based on the graded exercise test results and will be gradually increased with the goal of the participant exercising continuously for 30 minutes at 50% to 85% of symptom-limited maximum heart rate, or maintained at a level below that which causes symptomatic or silent ischemia. Following the aerobic phase of exercise, participants will complete one set of 8 to 12 repetitions of muscle-strengthening activities for all major muscle groups (legs, hips, back, abdomen, chest, shoulders, and arms). Participants will be provided with a home based aerobic exercise program. They will be encouraged to perform this home-based program twice a week on days when they are not attending the center-based program.<br>|
| No Intervention: Wait List Control<br>Wait-list-control participants will be asked to continue their normal activities over the 12 week period. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, rehabilitation, physical function