Clinical trial NCT04958161: Reconditioning Exercise for COVID-19 Patients Experiencing Residual sYmptoms
Official title: Reconditioning Exercise for COVID-19 Patients Experiencing Residual sYmptoms
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Covid19
Keywords: exercise
rehabilitation
physical function
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Performance Based Physical Function
timeFrame: Baseline
measure: Performance Based Physical Function
timeFrame: Week 12
measure: Self-reported Physical Function
timeFrame: Baseline
measure: Self-reported Physical Function
timeFrame: Week 12
Secondary outcomes:
measure: Physical Function
timeFrame: Baseline and Week 12
Other outcomes:
measure: Lung Volumes and Capacities
timeFrame: Baseline and Week 12
measure: Air Flow
timeFrame: Baseline and Week 12
measure: Diffusion Capacity
timeFrame: Baseline and Week 12
measure: Respiratory Muscle Weakness
timeFrame: Baseline and Week 12
measure: Exercise Capacity
timeFrame: Baseline and Week 12
measure: Cognitive Function
timeFrame: Baseline and Week 12
measure: Generic Health Related Quality of Life (HRQL) - Physical Component
timeFrame: Baseline and Week 12
measure: Generic Health Related Quality of Life (HRQL) - Mental Component
timeFrame: Baseline and Week 12
measure: Disease Specific Health Related Quality of Life (HRQL)
timeFrame: Baseline and Week 12
measure: Disability
timeFrame: Baseline and Week 12
measure: Fatigue
timeFrame: Baseline and Week 12
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University
name: Michael J Berry, PhD
role: PRINCIPAL_INVESTIGATOR
References: