Covid19RECOVERYNCT04958161
Reconditioning Exercise for COVID-19 Patients Experiencing Residual sYmptoms
A study testing Exercise Therapy in people with Covid19, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Exercise Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2022to May 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University
Winston-Salem, North Carolina, 27109
About this study
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.
Read the 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
- Being tested
- Exercise Therapy
- Keywords
- exercise, rehabilitation, physical function
- Medical subject headings
- COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Therapy | Experimental | Exercise therapy will be performed three times per week for 12 weeks. Receives: Other: Exercise Therapy |
| Wait List Control | No intervention | Wait-list-control participants will be asked to continue their normal activities over the 12 week period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 12
Secondary outcomes (1)
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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study startJan 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMay 2023 (estimated)
Why it stopped: Unable to enroll anyone.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J Berry, PhD, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958161
- Sponsor's protocol ID
- IRB00075690
- Acronym
- RECOVERY
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconditioning Exercise for COVID-19 Patients Experiencing Residual sYmptoms
- ClinicalTrials.gov ID
- NCT04958161
- Acronym / sponsor ID
- RECOVERY / IRB00075690
- Conditions
- Covid19
- Keywords
- exercise, rehabilitation, physical function
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll anyone.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Therapy | Experimental | Other: Exercise TherapyExercise therapy will be performed three times per week for 12 weeks. |
| Wait List Control | No intervention | –Wait-list-control participants will be asked to continue their normal activities over the 12 week period. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TherapyEach 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. | Other | Exercise Therapy |
Primary outcome
Performance Based Physical Function
Time frame: Baseline
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.
Performance Based Physical Function
Time frame: Week 12
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.
Self-reported Physical Function
Time frame: Baseline
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.
Self-reported Physical Function
Time frame: Week 12
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.
1 secondary outcome
Physical Function
Time frame: Baseline and Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be made available.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Berry, PhD principal investigator
Wake Forest University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Therapy in people with Covid19, run by Wake Forest University Health Sciences 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 7 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: withdrawn, as of the sponsor's last update on 24 Feb 2022. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Performance Based Physical Function (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2022.