Reconditioning Exercise for COVID-19 Patients Experiencing Residual sYmptoms

NCT ID: NCT04958161

Last Updated: 2022-02-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2023-05-31

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise Therapy

Exercise therapy will be performed three times per week for 12 weeks.

Group Type: EXPERIMENTAL

Exercise Therapy

Intervention Type: OTHER

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.

Wait List Control

Wait-list-control participants will be asked to continue their normal activities over the 12 week period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise Therapy

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael J Berry, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University

Locations

Wake Forest University

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00075690

Identifier Type: -

Identifier Source: org_study_id